LEEP-PRECISION Smoke Evacuation System Operating Manual Rev A March 2016

LEEP PRECISIONTM Smoke Evacuation System, 230 VAC (English)

System Description The CooperSurgical LEEP PRECISION Smoke Evacuation System LP-30-220 three-stage air filtration system is used to remove airborne particulate plumes produced during office and surgical procedures and has the following features: • Low noise level. • Triple filtration of air provides efficiency level for 0.014 microns rated at 99.999 percent. This includes a pre-filter, a charcoal filter for odor removal and a final safety filter placed after the charcoal filter. • High air flow for effective plume collection. • Conveniently attaches to the CooperSurgical LEEP PRECISION Integrated System-wall-mounted or free-standing.

Cautions • U.S. Federal law restricts this device to sale by or on the order of a physician. • This device produces a strong vacuum force and care should be exercised to ensure that the suction and the position of the inlet end of the suction tubing is adjusted properly to prevent injury to the patient or inadvertent damage to surgical materials. • The materials in the plume removed by this device are potentially hazardous. Handle according to 29 CFR 1910.1030 and OSHA 3127.1992 (Occupational Exposure to Bloodborne Pathogens) guidelines. • To prevent a fire or explosion hazard, do not use the system in the presence of flammable or potentially flammable materials. • Do not allow fluid to be pulled into the system. • To prevent premature failure of the ULPA filter cylinder, do not operate this device without a disposable Pre-Filter in place. • No modification of this equipment is allowed. • No Customer serviceable parts. • Only replacement of power cords or fuses can be done by the user. Only replace with these items with the exact replacement part(s) available from CooperSurgical.

Warning To avoid risk of Electrical Shock, this equipment must only be connected to a supply mains with protected earth.

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LP-30-220 • LEEP PRECISIONTM Smoke Evacuation System, 230 VAC Operating Manual • English (continued)

Initial System Setup The system arrives in one carton that contains the Vacuum Unit. The disposable accessories necessary to conduct procedures may be purchased separately from CooperSurgical.

ULPA Filter Installation Insert the large ULPA Filter cylinder with the Air Flow arrow pointing downward (see Photo A).

Photo A

Operating Instructions Prepare the unit for use by inserting a clean, disposable Pre-Filter onto the ULPA Filter cylinder (see Photo B). Be sure this device is firmly seated. Photo B

For procedures requiring close proximity plume removal (i.e., vaginal speculum) Assemble the ⅜-inch Reducer (Catalog number 6083) onto the port on the disposable Pre-Filter top with a slight twisting motion. Attach one end of an appropriate length of ⅜-inch inner diameter (ID) Evacuation Tubing (Catalog number 6084) to the Reducer Connector and direct the other end to the patient and any appropriate device being used, such as a vaginal speculum equipped with a Smoke Evacuation Adapter (see Photo C).

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Photo C

LP-30-220 • LEEP PRECISIONTM Smoke Evacuation System, 230 VAC Operating Manual • English (continued)

For procedures requiring open area plume removal (i.e., external lesions) 1.

Assemble the sterile Disposable Evacuation Tubing (Catalog number 6084) directly into the top of the Pre-Filter. Position the opposite end over the site to be treated.

2.

Plug the unit into an appropriate wall outlet (see the Specifications section).

3.

Push the POWER switch to the ON position to start the unit.

4.

At the completion of each procedure, activate the system to ensure safe particle containment. Using gloves and a mask, remove the Pre-Filter, the Reducer, and the used section of Suction Tubing and discard into an infectious waste receptacle (see Cautions). The CooperSurgical LEEP PRECISION Smoke Evacuation System LP-30-220 should be stored with a new Pre-Filter and Reducer in place on the ULPA filter.

NOTE: The expected life of the ULPA filter is 3–6 months depending on usage. It must be discarded into an infectious waste receptacle if plume odor is detected or the suction is diminished.

Maintenance Procedures No maintenance is required during normal operation other than making sure that ample space is maintained around the unit to allow for free air flow and adequate cooling.

Cleaning Procedures The outside of the unit may be cleaned as necessary with a soft cloth dampened (not wet) with isopropyl alcohol. Do not allow liquid to get inside of the unit.

Specifications Use Environmental Temperature: Relative Humidity: Air Pressure:

between +10 °C and +40 °C between 10 % and 90 % between 700 hPa and 1060 hPa

Shipping and Storage Environmental Temperature: Relative Humidity: Air Pressure:

between +10 °C and +40 °C between 10 % and 90 % between 700 hPa and 1060 hPa

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LP-30-220 • LEEP PRECISIONTM Smoke Evacuation System, 230 VAC Operating Manual • English (continued)

Fuses:

10A, 250V, T-Type, slow blow

Safety Class:

I

Power Rating:

2200 VA

Electrical:

230 VAC, 50 Hz

Size (W x D x H):

9 inches x 9 inches x 22 inches (22.86 cm x 22.86 cm x 53.24 cm)

Weight:

21 pounds (9.53 Kg)

Air Flow:

35 CFM minimum

Filter:

Pre-Filter, charcoal filter for odor removal, and hydrophobic ULPA filter rated at 99.999 percent efficiency level for 0.014 micron particles (based on Standard CNC Evaluations).

WEEE Directive In order to preserve, protect and improve the quality of the environment, protect human health and utilize natural resources prudently and rationally - do not dispose of waste electrical or electronic equipment (WEEE) as unsorted municipal waste. Contact local WEEE disposal sites.

Reordering Information Disposable Pre-filter:

Catalog (REF) number 6081

ULPA Filter:

Catalog (REF) number 6082

Reducer:

Catalog (REF) number 6083

Disposable Tubing (⅜ inch ID):

Catalog (REF) number 6084

Liability Statement CooperSurgical guarantees the safety, reliability, and performance of the LEEP PRECISION Smoke Evacuation System only if the installation, recalibrations, and repairs are performed by personnel authorized by CooperSurgical and if it is used in compliance with given instructions in an area that meets all applicable IEC requirements.

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LP-30-220 • LEEP PRECISIONTM Smoke Evacuation System, 230 VAC Operating Manual • English (continued)

Warranty Information CooperSurgical, Inc., warrants that the CooperSurgical LEEP PRECISION Smoke Evacuation System LP-30-220 (the “Product”) will be free from defects in materials and workmanship for a period of one (1) year from the original date of purchase. If the Product should become inoperable due to a defect in materials or workmanship during this one (1) year warranty period, CooperSurgical will at its option repair or replace the Product. The limited warranty does not include replacement or service to repair damage resulting from improper installation, external electrical fault, accident, disaster, negligence, modification, or use for any purpose other than that for which it was originally designed or indicated for use in this Operating Manual. This warranty does not cover service or repair by personnel not authorized by CooperSurgical nor normal wear and tear, and does not apply to disposable or single- or limited-use items or components. The sole and exclusive remedy under this Limited Warranty shall be repair or replacement as provided herein. The foregoing Limited Warranty states the sole warranty made by CooperSurgical with respect to the Product and all parts thereof, and is in lieu of any other warranty by CooperSurgical with respect to the Product. COOPERSURGICAL NEITHER MAKES NOR GRANTS ANY OTHER WARRANTY, EITHER EXPRESSED OR IMPLIED, WITH RESPECT TO THE PRODUCT, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT WILL COOPERSURGICAL BE LIABLE FOR ANY DAMAGES ARISING OUT OF THE LOSS OF USE OF THE PRODUCT OR ANY OTHER INCIDENTAL OR CONSEQUENTIAL DAMAGES, WHETHER OR NOT COOPERSURGICAL HAS ADVANCE KNOWLEDGE OF THE POSSIBILITY OF SAME. NOTE: No person, agent, distributor, dealer, or company is authorized to change or modify the terms of this limited warranty.

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LP-30-220 • LEEP PRECISIONTM Smoke Evacuation System, 230 VAC Operating Manual • English (continued)

To Obtain Warranty Service Contact the Service Department at CooperSurgical to obtain a Return Authorization Number. This Return Authorization Number must appear on all correspondence regarding your warranty claim; CooperSurgical is not required to accept a Product returned without a Return Authorization Number. The Product must be returned to CooperSurgical together with proof of date of purchase. All products must be properly disinfected prior to returning for service. All shipments to CooperSurgical must be insured and safely and securely packed, preferably in the original shipping carton. Include a letter explaining the problem and a reference to the Return Authorization Number. All return transportation and insurance charges must be prepaid by the customer and the customer will bear all risk of loss. If CooperSurgical determines that the Product requires repair covered under this Limited Warranty, CooperSurgical will repair or replace the Product as provided above and will return the repaired or replacement Product to the customer, freight prepaid with the risk of loss passing to the customer upon delivery to common carrier. If CooperSurgical determines that the Product requires a repair that is not covered by this Limited Warranty, CooperSurgical will either return the Product to the customer at the customer’s expense or contact the customer for further instructions. If so instructed by the customer, CooperSurgical will repair the Product and return the repaired Product to the customer, freight prepaid with risk of loss passing on the customer upon delivery to the common carrier. CooperSurgical shall be entitled to invoice the customer for the reasonable cost of non-warranty inspection and repair of the Product and the cost of the return freight. NOTE: There are no user-serviceable parts (excluding intermittent filter changes). Repairs should only be carried out by authorized CooperSurgical service personnel.

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LP-30-220 • LEEP PRECISIONTM Smoke Evacuation System, 230 VAC Operating Manual • English (continued)

CooperSurgical LEEP PRECISION Smoke Evacuation System EMC Compliance Information •

Medical electrical equipment requires special precautions regarding EMC and must be installed and put into service according to the EMC information provided in the accompanying documents.

•

Portable and mobile RF communications equipment can affect medical electrical equipment.

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The CooperSurgical LEEP PRECISION Smoke Evacuation System is intended for use in the electromagnetic environment specified below. The customer or the end user of the CooperSurgical LEEP PRECISION Smoke Evacuation System should assure that it is used in such an environment. Emissions Test

Compliance

RF Emissions CISPR 11

Group 1

RF Emissions CISPR 11

Class A

Harmonic Emissions IEC 61000-3-2

Class A

Voltage Fluctuations / Flicker Emissions IEC 61000-3-3

Complies

Electromagnetic Environment Guidance CooperSurgical LEEP PRECISION Smoke Evacuation Systems use only RF energy for their internal function. Therefore, RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. CooperSurgical LEEP PRECISION Smoke Evacuation Systems are suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

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LP-30-220 • LEEP PRECISIONTM Smoke Evacuation System, 230 VAC Operating Manual • English (continued)

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The CooperSurgical LEEP PRECISION Smoke Evacuation Systems are intended for use in the electromagnetic environment specified below. The customer or the end user of the CooperSurgical LEEP PRECISION Smoke Evacuation System should assure that it is used in such an environment. Immunity Test

Electromagnetic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4

Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency (50/60 Hz) magnetic field

IEC 60601 Test Level

Compliance Level

±6 kV contact

±6 kV contact

±8 kV air

±8 kV air

±2 kV for power supply lines

±2 kV for power supply lines

±1 kV for input/output lines

output lines

±1 kV differential mode

±1 kV for input/

Electromagnetic Environmental Guidance Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 percent. Mains power quality should be that of a typical commercial or hospital environment.

±1 kV differential mode ±2 kV common mode

Mains power quality should be that of a typical commercial or hospital environment.

<5% UT (>95% dip in UT) for 0.5 cycle

<5% UT (>95% dip in UT) for 0.5 cycle

Mains power quality should be that of a typical commercial or hospital environment.

40% UT (60% dip in UT) for 5 cycles

40% UT (60% dip in UT) for 5 cycles

70% UT (30% dip in UT) for 25 cycles

70% UT (30% dip in UT) for 25 cycles

<5% UT (>95% dip in UT) for 5 sec

<5% UT (>95% dip in UT) for 5 sec

3 A/m

3 A/m

±2 kV common mode

IEC 61000-4-8

If the user of the CooperSurgical LEEP PRECISION Smoke Evacuation System requires continued operation during power mains interruptions, it is recommended that the CooperSurgical LEEP PRECISION Smoke Evacuation System be powered from an uninterruptible power supply or a battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE UT is the a.c. mains voltage prior to application of the test level; in this case, 230 V.

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LP-30-220 • LEEP PRECISIONTM Smoke Evacuation System, 230 VAC Operating Manual • English (continued) Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environmental Guidance

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3V

3 V/m 80 MHz to 2.5 GHz

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the CooperSurgical LEEP PRECISION Smoke Evacuation System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Radiated RF IEC 61000-4-3

Recommended separation distance NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

d=

[ ]√ 3.5 V1

P

d=

[ ]√

P

80 MHz to 800 MHz

d=

[ ]√

P

800 MHz to 2.5 GHz

a Field strengths from fixed transmitters, such

as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcasts, and TV broadcasts cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the CooperSurgical LEEP PRECISION Smoke Evacuation System is used exceeds the applicable RF compliance level above, the CooperSurgical LEEP PRECISION Smoke Evacuation System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the CooperSurgical LEEP PRECISION Smoke Evacuation System. b Over the frequency range 150 kHz to 80 MHz,

field strengths should be less than 3 V/m.

9

3.5 E1

7 E1

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:

LP-30-220 • LEEP PRECISIONTM Smoke Evacuation System, 230 VAC Operating Manual • English (continued)

Recommended Separation Distance Recommended Separation Distance between portable and mobile RF communications equipment and the CooperSurgical LEEP PRECISION Smoke Evacuation System The CooperSurgical LEEP PRECISION Smoke Evacuation Systems are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the CooperSurgical LEEP PRECISION Smoke Evacuation Systems can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CooperSurgical LEEP PRECISION Smoke Evacuation Systems as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter in Watts

Separation distance according to frequency of transmitter (Meters) [Notes 1 & 2] 150 kHz to 80 MHz

d=

P [ 3.5 V ]√ 1

80 MHz to 800 MHz

d=

800 MHz to 2.5 GHz

1

[ E7 ]√ P

√P [ 3.5 E ]

d=

1

0.01

0.1167

0.1167

0.2333

0.1

0.3689

0.3689

0.7379

1

1.1667

1.1667

2.3333

10

3.6894

3.6894

7.3789

100

11.667

11.667

23.333

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output rating of the transmitter in watts (W) according to the transmitter manufacturer. For the CooperSurgical LEEP PRECISION Smoke Evacuation System: V1 = 3 Vrms E1 = 3 V/m NOTE 1:

At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2:

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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LP-30-220 • LEEP PRECISIONTM Smoke Evacuation System, 230 VAC Operating Manual • English (continued)

Explanation of Symbols REF

Reorder Number

This side up

Serial Number

High Voltage Symbol

Consult instructions for use. Manufacturer Date of Manufacture Caution Fragile Non-sterile Keep Dry

Symbol indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.

6D33

MEDICAL EQUIPMENT WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARD ONLY IN ACCORDANCE WITH UL60601-1 AND CAN/CSA C22.2 No.601.1

Product conforms to the Medical Device Directive 93/42/EEC.

EC REP

Authorized Representative in the European Community.

PRECISIONTM is a trademark of CooperSurgical, Inc. CooperSurgical is a registered trademark of CooperSurgical, Inc. © 2016 CooperSurgical, Inc.

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95 Corporate Drive Trumbull, CT 06611 USA Phone: (800) 243-2974 Fax: (800) 262-0105 International Phone: (203) 601-9818 Fax: (203) 601-4747 www.coopersurgical.com

37997 • Rev. A • 3/16

EC REP EMERGO EUROPE Molenstraat 15 2513 BH, The Hague The Netherlands CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT 06611 USA