Suction Unit LSU - With Reusable Abbott Canister Directions for Use Rev C

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1 Cautions and Warnings Read these Directions for Use carefully, and become thoroughly familiar with the operation and maintenance of the LSU before using it. The LSU should only be used by persons trained in the use of medical suction equipment. 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.

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. Use only accessories supplied by Laerdal or one of our authorised distributors to ensure that the LSU operates satisfactorily.

Battery: - To maintain satisfactory operation of the battery, it is recommended to place the LSU on continuous charge when not in use. - The 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. - 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 store the battery when it is discharged; always fully charge the battery before storage. Do not block the Exhaust Outlet during use.This will lead to reduced flow and can also cause damage to the LSU. Do not use the Reusable version without a filter or the Float Ball. Use only the disposable Abbott liner with filter. If overflow of liquid from the Canister into the pump is suspected, the LSU must be returned for service (see section 9). Overflow of suctioned material can damage the device. Disconnect the LSU from external power prior to cleaning. Use a minimum of liquid to prevent any electrical shock hazard.

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Cautions and Warnings...2 Introduction...4 Unpacking and prepare the LSU for use... 4 Indications for Use... 4 Contraindications... 4 Features and Benefits... 4 Limited Warranty... 4 Description... 5 Quick Reference Guide... 5 User Interface... 6 Canister Systems... 8 Power Sources... 9 Automatic Power-save Function... 9 Operation LSU with Reusable Canister... 10 Getting Started...10 Emptying the Canister...10 Assembly of the Reusable Canister System...11 After Use... 12 Operation LSU with Disposable Canister... 13 Getting Started... 13 Replace the Disposable Canister... 13 Assembly of the Disposable Canister System... 14 After Use... 15 Maintenance... 15 General...15 Battery...15 Cleaning the Cabinet...15 Decontamination of Reusable Parts...16 Charge the Battery... 17 Check the Battery Quality... 17 Replace the Battery... 18 Fastening brackets... 18 Release arm for Canister holder... 18 Device Test... 18 Setup... 18 Run the test... 18 Evaluation of Device test Results... 20 Accessories and Parts... 21 Servicing... 22 Trouble Shooting... 22 Specifications... 23

11.1 11.2 11.3 11.4 11.5 11.6 11.7 11.8 11.9 12

Contents 1 2 2.1 2.2 2.3 2.4 2.5 3 3.1 3.2 3.3 3.4 3.5 4 4.1 4.2 4.3 4.4 5 5.1 5.2 5.3 5.4 6 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9 7 7.1 7.2 7.3 8 9 10 11

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Classification... 23 General tolerance... 23 Physical Characteristics... 23 Operation... 23 Power Requirements... 24 Environmental Conditions... 24 Material Chart... 24 Symbols... 24 EMC Specifications... 25 Addresses... 27

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2 Introduction 2.1 Unpacking and prepare the LSU for use - Remove the LSU from its packaging and inspect all parts for damage. If there are any signs of damage or if any parts are missing, immediately notify Laerdal or one of our authorised distributors. - Insert the battery according to section 6.7. - Place the LSU on charge for a minimum of 24 hours to make sure you have a fully charged battery (see section 6.5). - After being charged for 24 hours, perform the Device Test according to section 7.

2.5 Limited 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 and tubing systems.

2.2 Indications for 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. 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. 2.3 Contraindications None known. 2.4 Features and Benefits - Splashproof, rugged and solid. - Easy access to the tubing. - Equipped with an internal battery that can easily be replaced without using tools. - Charging of battery can be done directly from AC or DC mains - no external charger is needed. - Fast charge option of 3 hours, giving approx. 80% battery capacity. - Operation possible from internal battery and directly from AC or DC mains - no adapter is needed. - A large combined ON/OFF switch and vacuum selector makes operation easy even with heavy-duty gloves. - A green LED bargraph makes it easy to observe the actual vacuum level during operation. - Another green LED bargraph indicates approx. remaining battery capacity. 4

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3 Description 3.1 Quick Reference Guide 3.1.1 LSU w/Reusable Canister System

Aerosol Filter

PATIENT Inlet

Vacuum Connector

Patient Suction Tubing

VACUUM Inlet

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

3.1.2 LSU w/Disposable Canister System

PATIENT Inlet

Vacuum Connector

Patient Suction Tubing

VACUUM Inlet User Interface

Vacuum tubing

Canister

Abbott liner with filter Canister Holder

T-bar

Release Arm Battery Door

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TEST-Button Vacuum Indicator Power ON Indicator

Battery Status Indicator

External Power Indicator Failure Mode Indicator

Operating Knob

3.2 User Interface

- 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.

3.2.1 Operating Knob The Operating Knob is a combined ON/OFF switch and vacuum selector, located at the bottom of the User Interface. 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.

3.2.2.2 External Power Indicator This green LED is continuously lit while external AC or DC power is connected. 3.2.2.3 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 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 9).

3.2.2 Indicators 3.2.2.1 Power ON Indicator This green LED has 3 modes: - It is lit continuously while the LSU is switched ON. - It flashes rapidly (approx. twice per second) during the Device Test.

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3.2.2.4 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).

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TYPICAL REMAINING BATTERY CAPACITY (for a new battery stored in room temperature ) > 50 % 30 - 50% 20 - 30% < 20%

OUTPUT 4 LEDs lit. 3 LEDs lit. 2 LEDs lit. 1 LED lit.

Battery Low; (min. 1 minute of operation left based on 500+ mmHg/free flow).

1 LED flashes.

During charging: indicates approx. achieved battery capacity. mmHg kPa mBar

80 11 107

120 16 160

200 27 267

350 47 467

500 67 667

CAPACITY < 75% 75 - 80% > 80%

3.2.2.5 Battery Status Indicator This green LED bargraph has 3 functions: - Indicates remaining battery capacity during operation from internal battery - Indicates approx. achieved battery capacity during charging - Indicates which test is currently in progress during device test

OUTPUT* The LED's will be lit sequentially. 3 LED's lit and 4th flashing. 4 LED's lit.

*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.

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.

3.2.3 TEST-Button 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).

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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3.3 Canister Systems The LSU can be delivered with a Reusable or a Disposable Canister System as described below. Both Canisters have a corresponding sized Canister Holder. 3.3.1 LSU Reusable Canister System

Patient Suction Tubing

Canister

PATIENT Inlet VACUUM Inlet.

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. - A Canister Lid w/Float Ball that prevents overflow if the Canister is full or the LSU tips over. - An Aerosol Filter with tubing that protects the LSU by preventing aerosols from entering the Pump Unit.* The Canister Lid contains a Float Ball that shuts off the vacuum if the canister is full or the LSU tips over.To reset the valve, remove the Angled Connector from the VACUUM Inlet. The LSU Reusable Canister System must not be used without the Aerosol Filter or the Float Ball. It is recommended always to have extra Aerosol Filters with the LSU in case one has to be discarded.

Aerosol Filter

Decontamination must be performed in accordance with section 6.4. For the Aerosol Filter the instructions below must be followed: - The Aerosol Filter is not designed for decontamination. - 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 or in areas where cross contamination is not an issue, the Aerosol Filter should be replaced at least once a month. - If the Aerosol Filter becomes wet, it should be replaced immediately or as soon as possible after use.

*The Aersol Filter is not intended for microbiological or for particle filtration.

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3.3.2 Disposable Canister System Disposable Parts

Reusable Parts

PATIENT Inlet Patient Suction Tubing

Reusable Canister T-bar Vacuum Connector Tubing

VACUUM Inlet Disposable Liner including lid with filter, tube and connectors The Disposable Canister System consists of: - A 1000 ml reusable transparent plastic Canister including a Canister Connector. - A disposable liner including lid with filter, tube and connectors. The Abbott Receptal® Canister 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 inner liner.

A Wall Bracket to hold the LSU during operation and (optional) charging is available separately (see section 8).

Note: Do not use an Abbott liner without a filter!

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.

AC Connector Socket DC Connector Socket

The disposable parts must be replaced after each use.The Reusable Canister must be cleaned as stated on the canister.The Vacuum Connector Tubing is reusable and should be cleaned in accordance with section 6.3.

3.5 Automatic Power-save Function The LSU has an Automatic Power-save Function that switches the pump motor off. While in this mode, the Power ON Indicator will flash slowly (approx. once per second). 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.

A Filter Tubing is available for the Abbott Canister System (see section 8). 3.4 Power Sources 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: - AC mains when used with the AC Power Cord: 100-240 VAC (50/60/400 Hz). - DC mains when used with the DC Power Cord: 12-28 VDC.

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4. Operating LSU with Reusable Canister 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.

5. 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. 6. When suction is complete, set the Operating Knob to "0"

4.1 Getting Started 1. Check that no parts are missing and that all parts are clean. 2. 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. 3. Ensure 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.

Note: To prevent overflow, the LSU must be transported in an upright position when the canister contains suctioned material. 4.2 Emptying the Canister 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. 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 9). When liquid reaches the top of the Canister, the LSU will stop suctioning.To continue suctioning, empty canister and replace the filter. Over flow of suctioned material can damage the device.

To remove the Canister, proceed as follows:

4 Unwrap the Patient Suction Tubing.

Note: The LSU must be operated in the upright position to prevent overflow of suctioned material.

1. Disconnect the Filter Tubing from the blue Vacuum Inlet (see section 3.3.1 regarding handling instructions for the Aerosol Filter). 10

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3. Secure the Lid to the Canister by turning it clockwise until it is securely fastened. 2. To release the Canister Holder, press down the Release Arm while sliding the Holder towards you. Remove the Canister from the Holder.

4. Connect the Suction Catheter Adapter to the Patient Tube.

3. Release the Patient Suction Tubing (if applicable). 4. Safely dispose of the contents of the Canister according to local protocols. 5. Clean the LSU according to section 6.3 and its reusable parts according to section 6.4.

5. Connect the Angled Connector to the Patient Tube.

4.3 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.

6. Mount the yellow Vacuum Seal in the centre hole of the Lid and push it into place.

2. If the Float Ball has been removed, hold the lid upside down and snap the ball into place as shown.

7. Connect the Aerosol Filter (blue ring) to the blue Vacuum Inlet on the LSU. (Color code: Blue on Blue)

Note: Never use the LSU without the Float Ball. 11

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8. Insert the Canister in the canister holder and slide it into the LSU.

4.3.1 Reusable Canister System 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. 2. Connect the yellow angled connector to the yellow Vacuum Seal. 3. Connect the Patient Tubing to the Patient inlet.

9. Connect the yellow Angled Connector to the yellow Vacuum Seal (Color code:Yellow on Yellow)

4.4 After Use - When suction is complete, set Operating Knob to ”0” and inspect all parts for damage or excessive wear. Replace parts if necessary. - Clean the LSU according to section 6.3 and its reusable parts according to section 6.4. - Perform the Device Test according to section 7. - Place the LSU on charge (see section 6.5).

10. Connect the Angled Connector on the Patient tubing to the PATIENT Inlet on the canister Lid. 11. Perform the Device Test according to section 7

12. Wind the Patient Tubing on the Patient Tubing Holder 13. Place the LSU on charge (see section 6.5) Note: Connect tubing according to color code: Blue on Blue & Yellow on Yellow.

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5. Operating LSU with Disposable Canister

8. When suctioning is complete, set the Operating Knob to "0"

5.1 Getting Started Note: Read all the Cautions and Warnings listed in section 1 thoroughly before you use the LSU.

Note: To prevent overflow the LSU should be transported in an upright position when the canister contains suctioned material.

1. Check that no parts are missing and that all parts are clean. 2. 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 battery is installed. 3. Ensure that the T-bar is securely tightened and the yellow connector from the Abbott liner goes to the yellow T-bar on the canister. (Yellow on Yellow). 4. Connect the blue Vacuum Tubing connector to the blue Vacuum Inlet on the LSU. (Blue on Blue). Connect the yellow connector to the yellow T-bar (Yellow on Yellow). 5. Ensure that the Patient Suction Tubing is securely connected to the PATIENT Inlet on the Canister Lid.

5.2 Replace the Disposable Canister Note: It is recommended to replace the Canister when it is 3/4 full. When liquid reaches the top of the Canister, the LSU will not suction any more liquid. If over flow of liquid from the Canister into the pump is suspected, the LSU must be returned for service (see section 9). Over flow of suctioned material can damage the device. To remove the Canister, proceed as follows:

1. Disconnect the Vacuum Connector Tubing at the yellow T-bar on the canister Connector.

6 Release the Strap holding the Patient Suction Tubing.

2. Release the Canister Holder, press down the Release Arm while sliding the Holder towards you. 3. Remove the Canister from the Holder.

Note: The LSU should be operated in the upright position to prevent overflow of suctioned material. 7. 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.

4. Unwrap/release the Patient Suction Tubing (if applicable).

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4. Insert the Canister in the in the Canister Holder and slide it into the LSU.

5. Safely dispose of the Abbott Liner according to local protocols. 6. Clean the LSU according to section 6.3. 5. Connect the yellow Connector on the Vacuum tubing to the Yellow T-Bar on the Abbott Canister (Color code:Yellow on Yellow).

5.3 Assembly of the disposable canister system

6. Connect the white Angled Connector to the Patient Tubing

1. Mount the Disposable Abbott Liner in the Abbott Canister

7. Connect the white Angled Connector to the white PATIENT INLET on the Abbott Liner (Color code: White on White) 8. Perform the Device Test according to section 7

2. Make sure that the yellow T-bar is securely tightened. Connect the yellow connector from the Abbott Liner to the yellow T-Bar on the Abbott Canister. (Color code:Yellow on Yellow).

9. Strap the Patient Tubing to the side of the LSU. 10. Place the LSU on charge (see section 6.5)

3. Connect the blue Vacuum Connector on the Vacuum Tubing to the blue Vacuum Inlet on the LSU. (Color Code: Blue on Blue).

Note: Connect tubing to color code: Blue on Blue, Yellow on Yellow & White on White. 14

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6. Maintenance 6.1 General - Make sure the maintenance instructions under section 4.4 and 5.4 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. 6.2 Battery - To maintain satisfactory operation of the battery, it is recommended to place the LSU on continuous charge when not in use. - Replace the battery when it does not pass the Battery Quality Check (see section 6.6 for details), or after 3 years. - Do not store the LSU with an empty battery.

5.3.1 Disposable Canister System Quick reference The assembly of the tubing is illustrated on the right side of the LSU. 1. Connect the blue Vacuum Connector on the Vacuum Tubing to the blue Vacuum Inlet. 2. Connect the two yellow connectors to the yellow T-bar on the Abbott canister. 3. Connect the white Patient Tubing to the white Patient inlet.

6.3 Clean the Cabinet Warning: Disconnect the LSU from external power prior to cleaning. 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.

5.4 After Use - When suction is complete, set Operating Knob to ”0” and inspect all parts for damage or excessive wear. Replace parts if necessary. - Clean the LSU according to section 6.3. - Perform the Device Test according to section 7. - Place the LSU on charge (see section 6.5).

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6.4 Decontamination of Laerdal Reusable Canister 6.4.1 Parts to be Decontaminated 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.

6.

1. 7.

2.

4.

3.

6.4.2 Preparation - Remove and empty the Canister according to section 4.2 - Disassemble the Canister into separate parts as indicated in the picture above. - The Float Ball on the reusable canister can be snapped out of the lid. 6.4.3 Rinsing - Rinse all parts under cold running water. - Immerse in warm water (30-40°C). 6.4.4 Cleaning - Immerse all parts in hot water (60-70°C) containing a mild detergent (see section 6.3). - Thoroughly clean all surfaces, use a brush where possible. - Rinse in warm water and allow to dry. - Inspect all parts to be visibly clean and dry. Note: Thorough rinsing and cleaning are very important steps prior to disinfection.

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6.4.5 Disinfection 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 in clean, warm water. Allow to dry.

Sodium Hypochlorite, (not cleared for use in the US)

Room temperature/ Conc.: 0.5%

20 minutes

Virkon

Room temperature/ Conc.: 1%

10 minutes

Rinse all parts in clean, warm water. Allow to dry.

Steam autoclaving

Autoclave at max. 121° C

20 minutes

Allow parts to cool.

6.5 Charge the Battery The internal rechargeable Lead-Acid 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: 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 3.2.2.5 for details). 3. The LSU must 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. Note: - To maintain satisfactory operation of the battery, it is recommended to place the LSU on continuous charge immediately after use. - 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.

Rinse all parts in clean, warm water. Allow to dry.

- Do not store the battery when it is discharged. Always fully charge the battery before storage. - 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. - If no battery is installed, the battery status indicator will be fully lit for approx. 5 sec. until it is turned off. 6.5.1 External Battery Charge The LSU battery can also be charged in an optional External Battery Charger. See section 8. 6.6 Check the Battery Quality If poor battery quality is LED 4____ suspected, charge the battery LED 3____ for a minimum of 24 hours and LED 2____ then perform the following test LED 1____ without connection to external power: - Run the Device Test and then 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.

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6.7 Replace the Battery Note: Use only batteries recommended by Laerdal.

7 Device test The Device test is user initiated test program for all models which can identify whether the LSU operates satisfactorily or if the LSU needs service.

1. Open the Battery Door. 2. To remove the battery, push and move it slightly to the left and then release. 3. Withdraw the battery from the LSU.* 4. To insert a battery, push it fully in and then to the right to lock it. 5. Close the Battery Door. 6. After inserting the battery, place the LSU on charge unless a fully charged battery is inserted.

The program runs 4 different tests: 1 It tests for occlusions in the Suction System (including canister and tubing) 2 It tests the vacuum build-up efficacy of the Pump System (How much vacuum is built up within 3 seconds) 3 It tests the maximum achievable vacuum level of the LSU (reaches this level within 10 seconds) 4 It tests if there are air leakages in the Pump System (including canister and tubing)

*When you discard the battery, dispose of safely in accordance with local protocols for sealed lead acid batteries.

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.

Fastening brackets

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 8.

7.2 Run the Test

1 Press and hold the TEST-Button while setting the Operating Knob to 500+ mmHg.

6.9 Release arm for Canister holder An extra release arm for the canister holder can be attached. See section 8.

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

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* 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. 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 until all 4 LED’s have illuminated and LED 1 lights up again.*

3 Keep the tubing blocked while LED 2 , 3 and 4 lights up.

4 Release the tubing when LED 1 comes on again 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: 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. 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. 19

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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

Test 1

Blockage in the LED #1 lit up Suction System (including canister and tubing

Battery indicator:

Test result indications

Action if test failed

Test Passed <100 mmHg

Check possible blockages (e.g. twisted tubing, blocked filter, blocked filter in the liner) and run the Device.Test again.

Fail 100 mmHg

Pass Test 2

Test 3

Test 4

The vacuum build-up efficacy of the Pump System (How much vacuum is built up within 3 seconds)

LED #2 lit up

The maximum achievable vacuum level of the LSU (reaches this level within 10 seconds)

LED #3 lit up

Test Passed >300 mmHg

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

Pass 300 mmHg

Fail

Air leakages in LED #4 lit up the Pump System (including canister and tubing)

Test Passed >500 mmHg

Pass 500 mmHg

Fail

Test Passed >450 mmHg

Pass

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

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

450 mmHg

Fail

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 section 9).

* 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.

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