Laerdal Compact Suction Unit (LCSU 3) Directions for Use Rev A

Important Safeguards/Introduction

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IMPORTANT SAFEGUARDS When using electrical products, especially when children are present, basic safety precautions should always be followed. Read all instructions before using. Important information is highlighted by these terms:

DANGER –

Urgent safety information for hazards that will cause serious injury or death.

WARNING – Important safety information for hazards that might cause serious injury. CAUTION –

Information for preventing damage to the product.

NOTE –

Information to which you should pay special attention.

READ ALL INSTRUCTIONS BEFORE USING.

Save These Instructions DANGER To reduce the risk of electrocution: 1. Do not place or store product where it can fall or be pulled into a tub or sink and come in contact with water. 2. Do not place in or drop into water or other liquid. 3. Do not reach for a product that has fallen into water. Unplug the mains supply cable immediately.

WARNING To reduce the risk of burns, electrocution, fire or injury to persons: 1. Close supervision is necessary when this product is used by, on, or near children or physically challenged. 2. Use this product only for its intended use as described in this guide. 3. Never operate this product if: a. It has a damaged power cord or plug. b. It is not working properly. c. It has been dropped or damaged. d. It has been dropped into water. Return the product to an authorized Laerdal Medical Service Center for evaluation and repair. 4. Keep the power cord away from heated surfaces.

DANGER  his suction unit is a vacuum suction device designed for the collection of nonflammable fluid materials in medical applications only. T Improper use during medical applications can cause injury or death. For all medical applications: 1. All suctioning should be done in strict accordance with appropriate procedures that have been established by a licensed medical authority. 2. Some attachments or accessories may not fit the tubing supplied. All attachments or accessories should be checked prior to use to assure proper fit.

Introduction Your suction unit is a compact medical suctioning device designed for reliable, portable operation. This suction unit is ideal for providing emergency suction in the field, transport, and hospital environment. Two collection container options include the 800 ml disposable canister and the 300 ml singleuse sealed disposable canister. To maximize product life and performance, follow recommended operating and maintenance procedures.

Intended Use Statement The device is to be used to remove fluids from the airway or respiratory support system. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection canister. The fluids are trapped in the collection canister for proper disposal.

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Suction Unit System/ Accessory/Replacement Items

EN Your Suction Unit system Inspect the suction unit and all parts before use.

WARNING-Do not attempt to use if any parts are damaged or missing.

88 00 50 Model (refer to Figures A1 and A2) 1. Bacteria Filter (non-sterile) 2. Connection Tubing (for use w/800 ml Canister) * 3. Display Panel (top of unit) 4. Unit Connection Elbow (for use w/ 800 ml) 5. Vacuum Inlet Port (side) 6. Tethered Plug 7. Wire Canister Bracket (for use w/800 ml canister only) 8. 800 ml Disposable Canister with Lid 9. 90° Canister Connection Elbow 10. Vacuum Regulator Knob (on side) 11. DC Power Input (on side) 12. Battery Door 13. Unit Carry Handle/Catheter Holder 14. 1,8 m (6’) Patient Tubing (not shown) 15. AC to DC Adapter/Charger and Line Cord (not shown) 16. High Capacity Rechargeable Battery (not shown) 12V DC Ni-MH 17. Carry Bag with Shoulder Strap (not shown) *Use only Laerdal replacement part 88 49 05 88 00 60 Model (refer to Figures B1 and B2) 1. Display Panel (top of unit) 2. Vacuum Inlet Port (side) 3. 300 ml Disposable Canister with 0.9m (3') Patient Tubing and Internal Bacteria Filter/Fluid Shut-off 4. Canister Tubing Fitting for Disposal 5. Tethered Plug 6. 12V DC Power Input (on side) 7. Vacuum Regulator Knob 8. Battery Door 9. Unit Carry Handle/Catheter Holder 10. AC to DC Adapter/Charger and Line Cord (not shown) 11. High Capacity Rechargeable Battery (not shown), 12V DC Ni-MH

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13

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10

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11 12

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Figures A1 and A2 - 88 00 50 model

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7

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Figures B1 and B2 - 88 00 60 model

Accessory/Replacement Items

The following items can be purchased separately as accessories or replacements for your suction unit.

Both Models

Description External Battery Charger (not shown) High Capacity Rechargeable Battery, 12V DC Ni-MH Tethered Plug Replacement Battery Door AC to DC Adapter/Charger Line Cord USA Hospital Grade Line Cord USA Line Cord UK Line Cord EU 12V DC Power Cord Vacuum Gauge Test Fixture (not shown)

Model 88 00 50

Part No. 88 00 70 04 88 00 70 05 88 00 70 06 88 00 70 07 88 44 00 88 44 01 88 44 02 88 44 03 88 44 04 88 45 00 88 50 00

Description Unit Connection Elbow 800 ml Disposable Canister Pack (incl Canister, Lid, Filter, Canister Elbow, Patient Tubing & Unit Elbow) Wire Canister Bracket (for 800 ml Canister) Carry Bag - w/Shoulder Strap 800 ml 800 ml Disposable Canisters (48 each) 800 ml Disposable Canisters (6 each) Bacteria Filter (12 each for the 800 ml Canister) 1,8 m (6') Patient Tubing (for 800 ml Canister) 90° Canister Connection Elbow (for 800 ml Canister) Connection Tubing (6 each for 800 ml Canister)

Model 88 00 60

Description Carry Bag - w/Strap 300 ml 300 ml Disposable Canister with Patient Tubing (10 each) A-8800

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Part No. 88 00 50 02 88 00 50 04 88 00 50 06 88 46 00 88 47 01 88 47 03 88 49 01 88 49 03 88 49 04 88 49 05 Part No. 88 00 60 05 88 60 00

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set-up Set-Up Battery Connection NOTE-All models of LCSU 3 are shipped with the battery in place but not connected. Follow the instructions below:

1. Using a coin or straight-blade screwdriver rotate latch to unlocked position (FIG. 1). 2. Remove door by pulling up on latch (FIG. 2). 3. Remove battery from compartment and plug connector into circuit board (FIG. 3). 4. Replace battery and door; rotate latch to locked position. 5. Fully charge battery for 5 hours before using (please see Battery Charging).

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

WARNING Do not attempt to connect any type of suction tubing directly into the vacuum inlet port. Only use with a Laerdal approved canister. NOTE-Always have a spare 300 ml canister within reach in case the canister in use is full or the filter becomes wet.

88 00 50 Model (800 ml Configuration): 1. Place canister into wire canister bracket; ensure inlet port marked <Patient> is accessible. 2. Attach one end of the connection tubing to connection elbow (FIG. 4). 3. Insert unit connection elbow into side port (FIG. 5). 4. Attach other end of connection tubing to side of filter marked <Out>. NOTE-Use only Laerdal supplied replacement filters (FIG. 6).

5. The 90° canister elbow connects to the clear side of filter marked <In> and to the top of canister lid marked <Vacuum> (FIG 6). NOTE-Verify clear side of filter marked <In> faces canister.

6. Connect the 1.8m (6') patient tubing to canister lid at inlet port labeled <Patient>. 7. Ensure all connections are secure to prevent leakage in the canister/tubing system. 8. Occlude the suction tube and set suction level according to local protocol before suctioning the patient (FIG 7). Be aware that it might be necessary to adjust the suction level during use.

88 00 60 Model (300 ml Configuration): 1. This single-use sealed disposable canister includes an internal filter and fluid shut-off that automatically stops suctioning when it becomes wet (FIG. 8). 2. Firmly attach canister by pushing connection fitting straight into the open side port of unit. (Both the top connection fitting and the bottom support tab secure the canister) (FIG. 9). 3. Securely attach appropriate suction tip to the tubing. 4. Occlude the suction tube and set suction level according to local protocol before suctioning the patient (FIG 7). Be aware that it might be necessary to adjust the suction level during use. NOTE-While suction unit will continue to operate if tipped on its side, canister capacity will be reduced. Keep a spare 300 ml disposable canister within reach.

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Operation

How to Operate Your Suction Unit Control Panel Symbols (Figure 10) On/Off  xternal power: Supplied from AC to DC Adapter/Charger or 12V DC Power E Cord. Illuminates in GREEN when power is supplied. Battery charging: Illuminates in YELLOW. The light will go out when the battery is fully charged. Low battery: Illuminates in RED when battery reaches a discharged state. mmHg

Figure 10

Suction level setting: Scale/strength illuminates in GREEN. This scale shows the level of suction strength in mmHg.

Power Source Options AC OPERATION - Plug the 90 degree power connector of AC to DC Adapter/Charger into DC power input (FIG 11) and connect the line cord. Plug the other end of AC to DC Adapter/Charger into a grounded AC supply. 12V DC OPERATION - Plug the small 90 degree power connector of 12V DC power cord into DC power input (FIG 11). Plug large end of cord into 12V DC power receptacle of vehicle. BATTERY OPERATION - Your unit is equipped with a high capacity rechargeable battery. For initial charge on new unit, fully charge the battery for a minimum of 5 hours (please see Battery Charging). NOTE–To operate unit from the rechargeable battery, ensure that no external power sources are plugged into the suction unit.

Figure 11

NOTE–During charging or operating, the power supply may become warm to touch; this is normal.

WARNING If you get the Low Battery Warning symbol, immediately switch to an external power source to avoid an interrupted suction procedure. If the unit does not receive external power or the battery does not get recharged immediately, the low battery indicator light will remain on and the performance of the unit will drop off rapidly and then shut down.

How To Adjust The Vacuum Level 1. Once power source is selected, turn the unit on by pressing the “On” button. The GREEN light, representing external power, will remain lit when external power is connected. 2. Occlude (block) the patient end of the tubing, then adjust vacuum level from 50 to 550 mmHg by turning the vacuum regulator knob clockwise to increase and counter-clockwise to decrease the vacuum (FIG 12). Release and occlude once more to confirm setting. The desired level of vacuum can be viewed on the LED display (FIG 10). NOTE–The LEDs have two brightness levels. As the vacuum level is adjusted the LEDs will illuminate in progression. When an LED is at half brightness, it indicates that the vacuum level is halfway between the previous fully lit LED and the half brightness LED. EXAMPLE: If the 150 mmHg LED is fully illuminated and the 200 mmHg LED is at half brightness, this indicates that the suction level is 175 mm Hg. When the 200 mmHg LED illuminates at full brightness, this indicates the unit has reached 200 mmHg. Attention should be taken when setting the different vacuum levels; and it might be necessary to adjust the suction level to local protocol during use.

3.

Figure 12

Connect suction tip or catheter as appropriate.

NOTE–If the unit does not maintain vacuum, refer to Troubleshooting. NOTE–For 88 00 50 Model, suction ceases when liquid level reaches float shut-off valve located on underside of 800 ml canister lid. For 88 00 60 Model, suction ceases when liquid level reaches filter located inside 300 ml canister.

NOTE–Dispose of canister and/or contents according to local protocol. CAUTION–Further suctioning attempts with a full canister may cause damage to the vacuum pump and voids warranty. Equipment service is required if fluid content is aspirated back into the unit.

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battery charging/ battery replacement/cleaning

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Battery Charging Models 88 00 50 & 88 00 60 Series are equipped with a factory-installed high capacity rechargeable battery. Located on the display panel is the low battery and charge indicator light (FIG 10). 1. Connect the unit to either an AC or DC power source. 2. The green external power light shall be illuminated. The yellow charge indicator will remain lit while the battery is charging. 3. Ensure that the yellow charging light is illuminated when charging begins. As the battery nears a full charge, the yellow battery charging light may flash for several minutes. This is normal. If your unit does not hold a charge, check that the yellow light turns on when external power is applied with the power button “Off”. If problems persist, contact an authorized Laerdal Medical Service Center. NOTE–Recharging the battery to full capacity may take up to 5 hours depending on the depth of discharge. If unit is not in use for extended periods, the battery should be recharged every 3-6 months. A fully charged battery will provide approximately 45-60 minutes of continuous operation at zero vacuum level (free flow). Unit can be left on charge when not in use. CAUTION–Completely discharging the battery will shorten the battery life. Do not operate the unit for more than a few minutes if the low battery indicator light is lit. Recharge the battery as soon as possible.

Battery replacement (refer to Battery Connection in Set Up) 1. Using a coin or straight-blade screwdriver rotate latch to unlocked position. 2. Remove door by pulling up on latch. 3. Remove battery from compartment and unplug connector from circuit board. 4. Install new battery by reversing the above steps. 5. Dispose of battery properly by following local protocol.

Cleaning Instructions Collection Canister: 1. 2. 3.

To remove canister, push power button to turn unit off. Wait for vacuum level to drop. Disconnect external power source from input receptacle on unit (if applicable). Remove canister from unit or holder by disconnecting the elbow, tubing and filter as needed.

NOTE–Insert tethered plug into side port of unit. 4. The 800 ml disposable collection canister and lid are for single-patient use only and must be discarded after use. The 300 ml disposable collection canister is meant for single-use only and must be discarded after use. NOTE–Before disposal of the 300ml canister, attach free end of tubing to the fitting at the bottom of the canister (FIG 13). This prevents liquid from leaking out of the canister.

Suction Unit:

Figure 13

1. With the power “Off,” disconnect the unit from all external power sources. 2. Wipe the outside housing with a clean damp cloth and detergent. CAUTION–Do not submerge suction unit in water as this will result in damage to vacuum pump. 3. If disinfection is desired, follow the disinfectant manufacturer's recommended instructions and dilution rates carefully.

Tubing: 1.

Disconnect tubing and discard; both patient tubing and connection tubing are considered single-patient use only.

Carry Bag: 1. 2.

Wipe the bag with a clean, damp cloth soaked with a mild detergent. If disinfection is desired, follow the disinfectant manufacturer's recommended instructions and dilution rates carefully.

Changing Filter (800 ml disposable canister): 1. Filter can be used for up to 2 months of use, but change filter immediately if contamination or discoloration is observed. 2. Remove the bacteria filter by disconnecting it from the suction unit and lid assembly. 3. Replace it with a new Bacteria Filter # 88 49 01 (12 each) and remount it to the suction unit and disposable canister lid.

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troubleshooting/ specifications/classifications

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NOTE–Verify clear side of filter marked <In> faces canister (FIG 14). NOTE–Use only the Bacteria Filter provided by Laerdal Medical or one of its Distributors. Substitution may lead to contamination of the unit and/or poor performance and will void warranty.

Troubleshooting NOTE–Before you return unit to an authorized Laerdal Medical Service Center, follow Troubleshooting protocol below: Figure 14

DANGER  lectric shock hazard. Do not attempt to open or remove cabinet, there are no user-serviceable internal components. If service is E required, return the suction unit to an authorized Laerdal Medical Service Center. Opening or tampering with the unit will void the warranty. Problem

Action

Unit does not power on. (Green external power indicator should be illuminated when power is applied.)

1. Check power sources and connections. 2. Ensure wall outlet is live by plugging in a lamp. 3. If operating from 12V DC, ensure DC outlet is live by plugging in known working device such as a cell phone charger. 4. Verify that battery is properly installed, connected and fully charged before use.

Pump runs, but no vacuum.

1. Check that all tubing is connected properly. 2. Check tubing connections for breaks, leaks, or occlusions. 3. Ensure that 800 ml suction canister float shut-off is not activated or that 300 ml canister filter is not clogged. 4. Check for leaks or cracks in canister assembly.

Low vacuum.

1. Use vacuum adjustment knob to increase vacuum level (return to local protocol level after test). 2. Check system for leaks.

Battery will not hold a charge. (Charge 1. Verify that charge light turns on. indicator should be illuminated if wbattery 2. Check electrical connections during charging. is connected during charge mode.) 3. Ensure wall outlet is live by plugging in a lamp. Battery seems insufficient, does not hold charge.

1. Perform the following test to determine if battery replacement is necessary: a. Charge battery as directed. b. Disconnect charging accessory and operate the LCSU 3 at free flow (no suction load and tubing unobstructed) for 20 minutes. If LCSU 3 stops before completing the 20 minutes, contact an authorized Laerdal Medical Service Center for advice regarding battery replacement.

NOTE–If problem is not resolved, contact your authorized Laerdal Medical Service Center:

Specifications/Classifications Size - H x W x D inches (cm) 88 00 50 Model (with 800ml collection canister and holder)... 8.5" x 7.75" x 9" (21.6cm x 19.7cm x22.9cm) 88 00 60 Model (with 300ml collection canister)... 7.1" x 10.5" x2.9" (18cm x 26.7cm x 7.4cm) Weight - lb. (kg) 88 00 50 Model ... 3.75 lbs. (1.70 kg) 88 00 60 Model ... 3.375 lbs. (1.53 kg) Electrical Requirements...100-240 VAC 47-63 Hz 0.75 A max; 12 VDC, 33 W max International Travel - The suction unit is equipped with an AC to DC Adapter/Charger allowing operation on any AC voltage (100-240 VAC, 50/60 Hz). However the correct power cord must be used to connect to adaptable wall power. (See Accessory List on page 4.) NOTE-Check power cord for adaptability before using. Internal Rechargeable Battery... 12 VDC Vacuum Range 88 00 50 & 88 00 60 Model ...50 to 550 mm Hg (+/- 27.5 mm Hg) Air Flow @ pump inlet:... 27 LPM (free flow) typical (may be less when running from internal battery) Collection Canister Capacity 88 00 50 Model ... Disposable 800 ml (cc) Maximum 88 00 60 Model ... Single-Use Sealed Disposable 300 ml (cc) Maximum A-8800

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warranty

NOTE–If either unit is operated off vertical or on an uneven surface, the collection canister overflow shutoff may activate prematurely, shutting off suction before canister achieves full capacity. Always have a spare replacement canister readily available.

Environmental Conditions Operating Temperature Range...32°F (0°c) - 104°F (40°c) Operating Relative Humidity... 0-95% Operating Atmospheric Pressure...10.2 Psi (70 kPA) - 15.4 Psi (106 kPA) Storage & Transport Temperature Range... -40°F (-40°C) - 158°F (70°C) Storage & Transport Relative Humidity... 0-95% Storage & Transport Atmospheric Pressure...7.3 Psi (50 kPA) - 15.4 Psi (106 kPA) Limited Warranty 88 00 50 & 88 00 60 Model...Two-years limited, excluding internal battery and collection canister Internal Battery... 90 Days Certifications IEC 601-1; IEC 68; CAN/CSA-C22.2 No. 601.1-M90; UL 2601-1, CE EN 60601-1-2, ISO10079-1:1999 Meets RTCA/DO-160E (for battery operation only; commercial aircraft, airborne equipment)... DO-160E - section 21 Category M NOTE - This unit complies with electromagnetic compatibility standards as defined in the included Declaration of Conformity. Equipment Classifications With respect to protection from electric shock...Class I and internally powered Degree of protection against electric shock... Type BF Applied Parts Degree of protection against ingress of liquids... IP12 and standard power supply Mode of Operation...Intermittent Operation: 30 minutes on, 30 minutes off WARNING-Do not use equipment in the presence of a flammable or anesthetic gas mixture.

ISO Classification 88 00 50 & 88 00 60 Models - Electrically powered medical suction equipment for field and transport use according to ISO 10079-1:1999 High Flow/High Vacuum

Two-Year Limited Warranty The compressor portion of the Laerdal Compact Suction Unit 88 00 50 & 88 00 60 Models (excluding internal rechargeable battery and collection canister) is warranted to be free from defective workmanship and materials for a period of two years from date of purchase. Internal rechargeable batteries are warranted for 90 days. Refer to the Laerdal Global Warranty for terms and conditions on www.laerdal.com. Any defective part(s) will be repaired or replaced at Laerdal Medical's option if the unit has not been tampered with or used improperly during that period. Make certain that any malfunction is not due to inadequate cleaning or failure to follow the instructions. If repair is necessary, contact your authorized Laerdal Medical Service Center for instructions. NOTE - Be sure to retain a dated proof of purchase document to verify unit is within 2-year warranty period. NOTE - This warranty does not cover providing a loaner unit or compensating for costs incurred in rental while said unit is under repair. THERE IS NO OTHER EXPRESS WARRANTY. IMPLIED WARRANTIES, INCLUDING THOSE OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE LIMITED TO THE DURATION OF THE EXPRESS LIMITED WARRANTY AND TO THE EXTENT PERMITTED BY LAW ANY AND ALL IMPLIED WARRANTIES ARE EXCLUDED. THIS IS THE EXCLUSIVE REMEDY AND LIABILITY FOR CONSEQUENTIAL AND INCIDENTAL DAMAGES UNDER ANY AND ALL WARRANTIES ARE EXCLUDED TO THE EXTENT EXCLUSION IS PERMITTED BY LAW. SOME STATES DO NOT ALLOW LIMITATIONS ON HOW LONG AN IMPLIED WARRANTY LASTS, OR THE LIMITATION OR EXCLUSION OF CONSEQUENTIAL OR INCIDENTAL DAMAGES, SO THE ABOVE LIMITATION OR EXCLUSION MAY NOT APPLY TO YOU. This warranty gives you specific legal rights, and you may also have other rights which vary from state to state.

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declaration of conformity Header

A Note From Laerdal Thank you for choosing a Laerdal Compact Suction Unit. We want you to be a satisfied customer. If you have any questions or comments, please send them to our address on the back cover. For service, call your authorized Laerdal Medical Service Center: Phone_ _____________________________________________________ Purchase Date________________________________________________ Serial #_____________________________________________________

Declaration of Conformity Manufacturer: Address:

Sunrise Medical dba DeVilbiss Healthcare 100 DeVilbiss Drive Somerset, PA 15501-2125 USA

Product Designation: Laerdal Compact Suction Unit 3 (LCSU 3) Type/Model:

88 00 50 & 88 00 60 Models

We herewith declare that the above-mentioned product complies with the requirements of EC Directive 93/42/EEC and the following: Class:

IIa, Rule 2

Quality System Standards Applied:

ISO13485:2003

Notified Body:

TÛV NORD

MDD:

Annex II Applied

Safety Standards Applied:

 L 2601-1 U EN 60601-1 CAN/CSA 22.2 No. 601.1-M90 ISO 10079-1:1999

EMC Compliance to:

IEC 801-2 through 5 CISPR 11/Level B EN 60601-1-2 RTCA DO-160E

For Battery Operation Only: RTCA/DO-160E, Section 21 Category M Commercial Aircraft, Airborne Equipment Authorized Representative:

S unrise Medical Ltd. Sunrise Business Park High Street Wollaston, West Midlands DY8 4PS ENGLAND 44-138-444-6688

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Distributed by: Laerdal Medical Corporation

Laerdal Medical AS

Laerdal Medical Canada Ltd.

167 Myers Corners Road

PO Box 377

151 Nashdene Road, Unit #45

Wappingers Falls, NY 12590 USA

Tanke Svilandsgate 30

Toronto, Ontario M1V 4C3 CANADA

Phone: 1-800-431-1055

4002 Stavanger

Tel: 1-416-298-9600

Fax: 1-800-227-1143

NORWAY

Toll free: 1-888-LAERDAL (1-888-523-7325)

www.Laerdal.com

www.Laerdal.com

ou en français 1-800-567-9987 Fax: 1-416-298-8016 www.Laerdal.ca

The Laerdal product and company name, and company logo are trademarks of Laerdal Medical AS. ©2008 Laerdal Medical AS. All rights reserved. A-8800 Rev. A