Laerdal Suction Unit LSU 78 00 00 and 78 00 30 Directions for Use Rev M

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2 Intended Use

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3 User Interface –– 3.1 Operating Knob  

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7 Device Test

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–– 7.1 Setup  

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–– 7.2 Run the Test

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–– 7.3 Evaluation of Device Test Results

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8 Servicing

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1 Cautions and Warnings

–– 3.2 Indicators  5

9 Troubleshooting 21

–– 3.3 TEST-Button  6 –– 3.4 Power Sources 

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–– 3.5 Automatic Power-save Function 

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10 Accessories and Parts

4 LSU Reusable Canister System –– 4.1 Overview  

11 Specifications 24 7

–– 11.1 Classification 24

–– 4.2 Parts 7 –– 4.3 Use  8 –– 4.4 Quick Reference

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–– 11.2 General Tolerance

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–– 11.3 Physical Characteristics

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–– 11.4 Operation 24

–– 4.5 After Use  11 –– 4.6 Decontamination of Laerdal Reusable Canister 11

–– 11.5 Power Requirements

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–– 11.6 Enviromental Conditions

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–– 11.7 Material Chart

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–– 11.8 Symbols 26

5 Serres Suction Bag System

–– 11.9 EMC Specifications

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–– 5.1 Overview 12 –– 5.2 Parts  

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–– 5.3 Use  

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–– 5.4 Quick Reference  

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12 Limited Warranty 28 13 Addresses 28

–– 5.5 After Use 15

6 Cleaning and Maintenance –– 6.1 General 16 –– 6.2 Clean the Cabinet and parts

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–– 6.3 Disinfection of reusable parts

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–– 6.4 Charge the Battery

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–– 6.5 External Battery Charger

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–– 6.6 Check the Battery Quality

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–– 6.7 Replace the Battery

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–– 6.8 Fastening the brackets

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–– 6.9 Release arm for Canister holder

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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.

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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

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To maintain satisfactory operation of the battery, it is recommended to place the LSU on continuous charge when not in use.

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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.

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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.

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Do not store the battery when it is discharged; always fully charge the battery before storage.

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We recommend charging a spare battery every 6 months when stored in room temperature at 25°C (77°F ).

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).

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The LSU must be charged between each clinical use

Disconnect the LSU from external power prior to cleaning. Use a minimum of liquid to prevent any electrical shock hazard.

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.

Battery

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 block the Exhaust Outlet during use. This will lead to reduced flow and can also cause damage to the LSU. Always use the Reusable version with the filter and the Float Ball in place.

2 Intended Use

Do not immerse the LSU or allow it to stand in water or other liquids. This might damage the device, and cause electrical 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 pump any cleaning solution or other liquids through the vacuum pump, i.e. through the Vacuum Connector. This can damage the LSU.

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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.

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3 User Interface (all configurations)

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

3.2 Indicators

80

120

200

350

500

kPa

11

16

27

47

67

mBar

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.

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It flashes rapidly (approx. twice per second) during the Device Test.

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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.

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Indicates remaining battery capacity during operation from internal battery

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Indicates approx. achieved battery capacity during charging.

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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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3.3 TEST-Button

Typical remaining Battery capacity 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.

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. 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 indication is targeted to show battery capacity as indicated below.The graph shows how the accuracy of the indication can vary.

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 Hz). • DC mains when used with the DC Power Cord: 12-28 VDC.

4 LEDs 3 LEDs

A Wall Bracket to hold the LSU during operation and (optional) charging is available separately (see section 10).

2 LEDs 1 LED

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

AC Connector Socket

Note: 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.

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.

3.5 Automatic Power-save Function

During charging: indicates approx. achieved battery capacity. Capacity < 75% 75 - 80% > 80%

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).

Output* The LED’s will be lit sequentially 3rd LED’s lit and 4th flashing 4 LED’s lit.

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.

*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.

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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. •

A Canister Lid w/Float Ball

•

An Aerosol Filter with tubing

Aerosol Filter Connector from the VACUUM Inlet. The Float Ball will be released and the Angled Connector can be reattached, 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”

4.3.1 Check list •

Check that no parts are missing and that all parts are clean.

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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.

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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.

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Check that a suction catheter is attached to the patient suction tube or suction adapter. Do not use the suction tube or suction adapter without a suction catheter attached.

4.3.3 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 8). 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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4 Safely dispose of the contents of the Canister according to local protocols.

To remove the Canister, proceed as follows:

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 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.

12 Wind 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.

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Disassemble the Canister into separate parts as indicated in the picture above.

3 Connect the Patient Tubing to the Patient inlet.

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The Float Ball on the reusable canister can be snapped out of the lid.

4.5 After Use

4.6.3 Rinsing

2 Connect the yellow angled connector to the yellow Vacuum Seal.

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When suction is complete, set Operating Knob to ”0” and inspect all parts for damage or excessive wear. Replace parts if necessary.

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Clean the LSU and its reusable parts according to section 6.2

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Perform the Device Test according to section 7.

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Rinse all parts under cold running water.

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Immerse in warm water (30-40°C).

4.6.4 Cleaning •

Immerse all parts in hot water (60-70°C) containing a mild detergent (see section 6.3).

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Thoroughly clean all surfaces, use a brush where possible.

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Rinse in warm water and allow to dry.

4.6 Decontamination of Laerdal Reusable Canister

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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.

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Place the LSU on charge (see section 6.4).

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 Suction Tube Serres Suction Tube

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Suction Bag with Filter

Serres Vacuum Connector

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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5.3.2 Using the LSU

The reusable canister must be cleaned if needed according to manufacturer’s instructions for use.

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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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 Perform the Device Test according to section 7.

6 Insert the opposite side of the Serres Vacuum Connector into the canister.

11 Fasten the Suction Tubing on the Suction Tubing Holder

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5 Fully insert canister holder into the LSU.

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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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

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.

60 minutes

Post-treatment

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•

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.

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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.

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. •

If the LSU stops before completing the 20 minutes, the battery should be discarded.

•

Do not store the battery when it is discharged. Always fully charge the battery before storage.

6.7 Replace the Battery

•

Do not store the LSU with a discharged battery.

•

The recommended ambient temperature for charging is from 15°C to 25°C.

Note: Use only batteries recommended by Laerdal Medical.

•

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.

•

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.

•

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 ).

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. *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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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, Vacuum Connector, Angled Connector with Patient 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.

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7.2 Run the Test

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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7.3 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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English

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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