Laerdal Compact Suction Unit (LCSU) Model 88 00 xx series Instruction Guide Rev C

English

2

IEC Symbols / Important Safeguards

TABLE OF CONTENTS IEC Symbols ... Important Safeguards ... International Travel ... Introduction ... Important Parts of Your Suction Unit ... Accessory/Replacement Items ... Set-Up... How to Operate Your Suction Unit ... Battery Charging ... Cleaning Instructions ... Maintenance ... Troubleshooting ... Specifications/Classifications ... Warranty ... Declaration of Conformity ...

2 2 3 3 3 4 4 4 5 5 6 6 7 8 8

Español Instrucciones ... 9 Français ... 16 Deutsch... 23 Italiano... 30 Nederlands ... 37 IEC SYMBOLS Attention, consult instruction guide

Alternating current

Direct current

Type BF applied part

“On” compressor

“Off” compressor (external battery charging)

Center positive polarity indicator

IPX2 vertically falling drops shall have no harmful effects when the enclosure is tilted at an angle up to 15° on either side of the vertical.

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 100-405-00

I n t e r n a t i o n a l Tr a v e l / I n t r o d u c t i o n / I m p o r t a n t P a r t s

3

English

DANGER To reduce the risk of electrocution: 1. 2. 3. 4.

Do not use while bathing. Do not place or store product where it can fall or be pulled into a tub or sink. Do not place in or drop into water or other liquid. Do not reach for a product that has fallen into water. Unplug 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 invalids. 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 examination and repair. 4. Keep the power cord away from heated surfaces. 5. Never use while drowsy or asleep. NOTE– The 88 00 40 series is not factory equipped with an internal rechargeable battery; it may be purchased separately and installed by your Laerdal Medical provider. 88 00 20 and 88 00 30 series are factory equipped with an internal rechargeable battery and all information regarding battery operation in this guide is applicable.

DANGER This suction unit is a vacuum suction device designed for the collection of nonflammable fluid materials in medical applications only. 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.

INTERNATIONAL TRAVEL The suction unit is equipped with a switch mode power supply 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. NOTE– Check power cord for adaptability before using.

INTRODUCTION Your suction unit is a compact medical suctioning device which has been designed for reliable, portable operation. Because of the small size, light weight and multi-source powering, this suction unit is ideal for providing emergency suction in the field, home, transport, and hospital treatment environment. Two collection bottle options give the choice between the economical 800 ml disposable canister or the 1,200 ml reusable canister. Following the recommended operating and maintenance procedures outlined in this instruction guide will maximize the life of this product.

IMPORTANT PARTS OF YOUR SUCTION UNIT (refer to diagram) Description Factory equipped on models: 1 Bacteria filter (non-sterile) All models 2 4" Connection tubing All models -- 8mmID FDA approved Silicone tubing. Use only specified connection tubing 3 Vacuum gauge All models for replacement. 4 Tubing connector All models 5 Vacuum regulator knob All models 6 DC power input (on side) All models 7 Power switch All models 8 6' patient tubing All models -- .25”ID x 6’ FDA approved PVC tubing 9 800 cc disposable canister w/lid All models with connecting couplers. Use only specified patient tubing for replacement. (float shut off incorporated into lid) 10 90° connection elbow All models All models Switch mode adapter (not shown) Internal rechargeable battery (not shown) 88 00 20 & 88 00 30 series Carrying case (not shown) All models DC Cable (not shown) All models All models Mains Cable (not shown)

10

1

2

3

4

9

5 8

6 7

NOTE– This unit complies with electromagnetic compatibility standards as defined in the included Declaration of Conformity. 100-405-00

English

4

Accessory & Replacement Items / Set-Up / Operation

ACCESSORY/REPLACEMENT ITEMS The following items can be purchased separately as accessories or replacement items for your suction unit: Description Switch mode AC to DC adapter/charger Line cord for US Hospital grade line cord (120 VAC) Line cord for UK Line cord for Continental Europe Line cord for Australia 12V DC power cord (1 each) Fuse for 12VDC Cord, 3A Carrying case (softpack w/shoulder strap) Shoulder strap (only) 800 ml Disposable collection bottle (48 each) Filter, 800ml collection bottle, elbow & tubing package 1200 ml Reusable collection bottle (16 each) 1200ml bottle package Bacteria filter (non-sterile) (12 pack) 6’ Patient Tubing Vacuum gauge test fixture

Part No. 88 44 00 88 44 01 88 44 02 88 44 03 88 44 04 88 44 05 88 45 00 88 45 01 88 46 00 88 46 01 88 47 01 88 47 02 88 48 01 88 48 02 88 49 01 88 49 03 88 50 00

SET-UP 1. Connect either end of the 4" tubing to the tubing connector then connect the other end to the bacteria filter. Ensure that the clear side of the bacteria filter is toward elbow and bottle when installing/re-installing. Do not reverse direction of filter. 2. The bacteria filter should then be connected to the 90˚ elbow connection, and the 90˚ connection should be connected to the top of the canister lid where it says <Vacuum>. 3. The 6' patient tubing should be connected to the canister lid at the outlet labeled <Patient>. 4. Please assure that all connections are secure and without leaks before using. 5. Verify that unit is at desired suction level before beginning patient suction.

HOW TO OPERATE YOUR SUCTION UNIT Before connecting the unit to the AC adapter or 12V DC cord, make sure that the power switch located on the side of the unit is in the “Off” position. Select power source desired. LED Explanations: L1- Green– External power supplied to unit from AC power source or DC cord. Illuminated when external power is supplied. L2 - Yellow– Battery is being charged. Light will go out when battery is fully charged (88 00 20 & 88 00 30 Series only). L3 - Red– Low battery. Seek another power source and charge battery as soon as possible when light remains on continuous (88 00 20 & 88 00 30 Series only). AC OPERATION– Plug the small connector of the AC adapter into the DC power input located on the side of the unit. Plug the AC end into a grounded wall-outlet power source. NOTE– The power supply may become warm to the touch during charging or running of the unit. This is normal.

12V DC OPERATION– (such as a car lighter receptacle). Plug the small connector of the DC power cord into the DC power input on the side of the unit. Plug the large connector into the 12V DC power receptacle of the automobile. BATTERY OPERATION– Verify that your unit has an internal rechargeable battery; factory installed on 88 00 20 and 88 00 30 series or provider installed on 88 00 40 series (installed as an option). To ensure proper operation from internal battery, fully charge the battery for 10-17 hours as explained in the Battery Charging section. To operate the unit from an internal rechargeable battery, ensure that no external power sources are plugged into the DC power input on the side of the unit. Once the power source is selected, simply turn the unit “On” using the power switch located on the side of the unit. The power indicator light (displayed on the top of the unit) will indicate which power source is being used by staying continuously lit when external power is connected.

If the unit does not receive an external power source 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. Switch to another power source immediately to avoid an interrupted suction procedure. 100-405-00

Battery Charging / Cleaning

5

English

Adjust the vacuum level from 80 to 550 mm Hg by turning the vacuum regulator knob located on the side of the unit (clockwise to increase vacuum and counter-clockwise to decrease vacuum). The desired level of vacuum can be set by using the gauge located on the top of the unit near the handle. To accurately read the gauge, block the patient end of the hose or cap off the collection bottle and allow the gauge to reach a stable vacuum reading. NOTE– Gauge is for reference only. If the unit sustains a severe drop, validity of the gauge must be checked.

Suction at the patient is automatically obstructed when liquid level reaches the float shut-off located on the underside of the collection bottle lid. NOTE– Always transport unit with vacuum regulator knob rotated fully clockwise in case unit is dropped. CAUTION– When automatic float shut-off is activated, contents of the collection bottle should be emptied. Further suctioning could cause damage to the vacuum pump. CAUTION– Should fluid be aspirated back into the unit, equipment provider servicing is necessary as possible vacuum pump damage may result.

BATTERY CHARGING On 88 00 20 and 88 00 30 series, the units are equipped with a factory-installed rechargeable battery. The unit will have a light for low battery and charge indication. On 88 00 40 series, the units are not factory equipped with a rechargeable battery; check with your equipment provider to determine if your unit has been upgraded with a rechargeable battery. Once you've determined that your unit is equipped with an internal rechargeable battery, connect the unit to the proper AC or DC power source using the AC adapter or DC power cord. The green external power light shall be illuminated. The yellow charge indicator will be illuminated while the battery is charging. Verify that this illuminates when charging begins. As the charge nears a full charge, the yellow LED may flash on and off for several minutes. This is normal. NOTE– A discharged battery will require 10-17 hours (depending on depth of discharge) of charging to reach a full capacity. NOTE– Do not connect the AC adapter to an outlet controlled by a switch to ensure power is supplied to unit at all times. NOTE– Do not connect the DC power cord to an outlet that is not constantly energized. NOTE– A fully charged battery, on the 88 00 20 and 88 00 30 series will provide approximately 60 minutes of continuous operation at a zero vacuum level (free flow). NOTE– If unit is not in use for extended periods, battery should be recharged every 6 months minimum. CAUTION– Discharging the battery completely will shorten the life of the battery. Do not operate the unit more than a few minutes if the low battery indicator light is lit. Recharge as soon as possible. NOTE– When charging the battery, the battery charging indicator light will remain lit. If your unit does not hold a charge, please be sure the model you are using has a battery installed prior to returning it to your authorized Laerdal Medical provider or to Laerdal Medical. Verify that the charge light turns on when the external power is applied with the switch in the “Off” position. NOTE– Units equipped with an internal rechargeable battery contain a sealed lead-acid battery which must be recycled.

CLEANING INSTRUCTIONS Collection Bottle: 1. Shut off unit using power switch and allow vacuum to drop. Disconnect power source from the DC input receptacle on the unit. 2. With the collection bottle still in the holder, remove the lid. The bottle can now be taken out of the holder to be emptied. NOTE– The 800ml disposable collection bottle and lid are meant for single-patient use only and must be discarded after use.

3. Reusable 1200 ml collection bottles and lids should be thoroughly cleaned after each use by one of the following methods: l Wash in a hot water/dishwashing detergent solution and rinse with clean, hot tap water. Then wash in one part vinegar to three parts hot water solution. Rinse with hot tap water and air dry. l Wash in a hot water/dishwashing detergent solution and rinse with clean, hot tap water. Then wash with rubbing alcohol and air dry. l Wash in a hot water/dishwashing detergent solution and rinse with clean, hot tap water. Then wash with a commercial (bacterial-germicidal) disinfectant, follow disinfectant manufacturer's recommended instructions and dilution rates carefully. l Clean the 1200 ml autoclavable jar, lid assembly, gasket, seal washer, float guide, and float thoroughly with mild soap. Rinse thoroughly with clean water and dry thoroughly. Place parts in autoclave as follows ensuring the parts are not touching: l Jar with open end down. l Float and float guide upright with large ends down. l Gasket and seal washer can be placed in a gusset pouch prior to autoclaving. Autoclave for 3 to 5 minute cycle at 270ºF (132ºC). In lieu of autoclave sterilization, the above parts can be soaked in an activated dialdehyde solution. Suction Unit: 1. With the power switch in the “Off” position, disconnect the suction unit from all external power sources. 2. Wipe the housing with a clean cloth and any commercial (bacterial-germicidal) disinfectant. CAUTION– Do not submerge in water as this will result in damage to the vacuum pump.

100-405-00

English

6

M a i n t e n a n c e / Tr o u b l e s h o o t i n g

Tubing: 1. Disconnect the tubing from the unit. 2. Tubing should be rinsed thoroughly after every use by running hot tap water through it followed by a solution of one part vinegar to three parts hot water. 3. Rinse with hot tap water and air dry. 4. Keep the outer surface of the tubing clean by wiping with a clean, damp cloth. Carrying Case: 1. Wipe the case using a clean cloth dampened with detergent and/or disinfectant.

MAINTENANCE Inspect suction tubing and collection bottle for leaks, cracks, etc. before each use.

DANGER Electric shock hazard. Do not attempt to open or remove cabinet, there are no user-serviceable internal components. If service is required, return unit to a qualified Laerdal Medical provider or an authorized service center. Opening or tampering with the unit will void warranty. Filter Changing: 1. Change bacteria filter if overflow occurs or every two months, whichever comes first. 2. Remove filter by disconnecting it from suction unit and lid assembly. 3. Replace with a clean Laerdal bacteria filter (non-sterile) 88 49 01 (12/pack) and remount to suction unit and lid. Additional filters may be purchased from your authorized Laerdal Medical provider. NOTE– Do not substitute any other material for this bacteria filter. Substitution may lead to contamination or poor performance; use only Laerdal filters.

TROUBLESHOOTING NOTE– Your suction unit contains no user-serviceable parts. If you believe your unit is not working properly, BEFORE YOU RETURN IT TO THE HOME MEDICAL EQUIPMENT PROVIDER WHERE YOU PURCHASED IT OR TO Laerdal Medical, please take a few moments to check for these possible causes:

100-405-00

Problem

Action

Unit does not turn 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 running from an internal battery, ensure that your unit has a battery installed. 4. If battery is installed, check that it is fully charged.

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 flow shut-off is not activated. 4. Check for leaks or cracks in bottle assembly.

Low vacuum.

1. Use vacuum adjustment knob to increase vacuum level. 2. Check system for leaks. 3. Push vacuum adjustment knob and then release.

Battery will not hold a charge. (Charge indicator should be illuminated if battery is connected during charge mode.)

1. Ensure that unit is equipped with an internal battery by contacting your Laerdal Medical equipment provider. 2. Verify that charge light turns on. 3. Check electrical connections during charging. 4. Ensure wall outlet is live by plugging in a lamp.

Battery seems not to hold a 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 at free flow (no suction load and tubing unobstructed) for 20 minutes. If LCSU stops before completing the 20 minutes, contact Laerdal to arrange for battery replacement.

Specifications / Classifications

English

7

SPECIFICATIONS/CLASSIFICATIONS Size

H x W x D inches (cm)

88 00 20, 88 00 30, & 88 00 40 Series...9.0 x 7.0 x 8.0 (22.9 x 17.8 x 20.3) Weight

lb. (kg)

88 00 20 & 88 00 30 Series...6.3 (2.9) 88 00 40 Series...3.8 (1.7) Electrical Requirements... 100-240 V AC 50/60 Hz 0.75 A max; 12 V DC, 33 W max Internal Rechargeable Battery 88 00 20 & 88 00 30 Series...Factory Equipped 88 00 40 Series...Not Factory Equipped (provider-installed option) Vacuum Range 88 00 20, 88 00 30, & 88 00 40 Series...80 to 550 mm Hg Air Flow @ pump inlet: ...27 LPM (free flow) typical (may be less when running from internal battery) Collection Bottle Capacity 88 00 20 & 88 00 40 Series...800 ml (cc) Disposable 88 00 30 Series...1,200 ml (cc) Reusable 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) Warranty 88 00 20 & 88 00 30 Series...Two-years limited, excluding internal battery and collection bottle 88 00 40 Series...Two-years limited, excluding collection bottle Internal Battery...90-day Approvals 88 00 20, 88 00 30, & 88 00 40 Series...IEC 601-1; CAN/CSA-C22.2 No. 601.1-M90; UL 2601-1, CE EN 60601-1-2 88 00 20 & 88 00 30 Series meets RTCA/D-160D...DO-160D - section 20 Category U DO-160D - section 21 Category L For battery operation only Airline use 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...IPX2 and ordinary power supply Mode of Operation...Intermittent Operation: 30 minutes on, 30 minutes off Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or nitrous oxide. ISO Classification 88 00 20 & 88 00 30 Series only - Electrically powered medical suction equipment for field and transport use according to ISO 10079-1 : 1991 High Flow/High Vacuum 88 00 40 Series - Electrically powered medical suction equipment for non-transport use according to ISO 10079-1 : 1991

100-405-00

English

8

Wa r r a n t y / D e c l a r a t i o n o f C o n f o r m i t y

TWO-YEAR LIMITED WARRANTY The compressor portion of the Laerdal Compact Suction Unit 88 00 20, 88 00 30, & 88 00 40 Series (excluding internal rechargeable battery and collection bottle) 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. 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 Laerdal Medical Provider or Laerdal Medical 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, compensating for costs incurred in rental while said unit is under repair, or costs for labor incurred in repairing or replacing defective part(s).

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. Manufacturer's Note 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 Provider: Phone ___________________________________ Purchase Date ____________________________ Serial #__________________________________

DECLARATION OF CONFORMITY Manufacturer: Address

Sunrise Medical Respiratory Products Division 100 DeVilbiss Drive Somerset, PA 15501-2125 USA

Product Designation:

Laerdal Compact Suction Unit (LCSU)

Type/Model:

88 00 20, 88 00 30, & 88 00 40 Series

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:

IS09001/ISO13485

Notified Body RWTÛV MDD Annex II Applied Safety Standards Applied: UL 2601-1 IEC 601-1 CAN/CSA 22.2 No. 601.1-M90 ISO 10079-1 EMC (Electromagnetic Compatibility) Compliance to:

For Battery Operation Only:

IEC 801-2 through 5 CISPR 11/Level B EN 60601-1-2

DO-160D, Section 20 Category U; Section 21 Category L. For Airline Use

Authorized Representative: Sunrise Medical Ltd. Sunrise Business Park High Street Wollaston, West Midlands DY8 4PS ENGLAND 44-138-444-6688 0044 100-405-00

Manufactured for & 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

4002 Stavanger

Toronto, Ontario M1V 4C3 CANADA

Phone: 800-431-1055

NORWAY

Tel: +1 (416) 298-9600

Fax: 800-227-1143

www.Laerdal.com

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

www.Laerdal.com

ou en français (800) 567-9987 Fax: +1 (416) 298-8016 www.Laerdal.com

The Laerdal name and logo are trademarks of Laerdal Medical. All rights reserved. 100-405-00 Rev. C