Cooper Surgical LEEP PRECISION LP-30-220 User manual

LEEP PRECISION™

Smoke Evacuation System, 230 VAC

Operating Manual (English)

Bedienungsanleitung (Deutsch / German)

Manual de funcionamiento (Español / Spanish)

Manuel d’utilisation (Français / French)

Manuale di funzionamento (Italiano / Italian)

Manual de funcionamento (Português / Portuguese)

操作手册（简体中文 / Mandarin Chinese)

REF LP-30-220

English . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 1

Deutsch / German . . . . . . . . . . . . . . . . . . . . . . Seite 12

Español / Spanish . . . . . . . . . . . . . . . . . . . . Página 23

Français / French . . . . . . . . . . . . . . . . . . . . . . Page 34

Italiano / Italian . . . . . . . . . . . . . . . . . . . . . . . Pagina 45

Português / Portuguese . . . . . . . . . . . . . . . . Página 56

简体中文 / Mandarin Chinese . . . . . . . . . . . . 页码 67

95 Corporate Drive

Trumbull, CT 06611 USA

Phone: (800) 243-2974

Fax: (800) 262-0105

www.coopersurgical.com

International

Phone: (203) 601-9818

Fax: (203) 601-4747

EMERGO EUROPE

Molenstraat 15

2513 BH, The Hague

The Netherlands

CooperSurgical, Inc.

95 Corporate Drive

Trumbull, CT 06611 USA

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.

LEEP PRECISIONTM Smoke Evacuation System, 230 VAC

(English)

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).

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.

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).

Photo B

LP-30-220 • LEEP PRECISIONTM Smoke Evacuation System, 230 VAC

Operating Manual • English (continued)

Photo C

Photo A

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: between +10 °C and +40 °C

Relative Humidity: between 10 % and 90 %

Air Pressure: between 700 hPa and 1060 hPa

Shipping and Storage

Environmental Temperature: between +10 °C and +40 °C

Relative Humidity: between 10 % and 90 %

Air Pressure: between 700 hPa and 1060 hPa

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.

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.

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.

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 Electromagnetic

Environment Guidance

RF Emissions

CISPR 11

Group 1 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.

RF Emissions

CISPR 11 Class A 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.

Harmonic Emissions

IEC 61000-3-2 Class A

Voltage Fluctuations /

Flicker Emissions

IEC 61000-3-3 Complies

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 IEC 60601

Test Level

Compliance

Level

Electromagnetic

Environmental -

Guidance

Electromagnetic

discharge (ESD)

IEC 61000-4-2

±6 kV contact

±8 kV air

±6 kV contact

±8 kV air

Floors should be wood,

concrete, or ceramic tile.

If floors are covered with

synthetic material, the

relative humidity should

be at least 30 percent.

Electrical fast

transient/burst

IEC 61000-4-4

±2 kV for power

supply lines

±1 kV for input/output

lines

±2 kV for power

supply lines

±1 kV for input/

output lines

Mains power quality

should be that of a typical

commercial or hospital

environment.

Surge

IEC 61000-4-5

±1 kV differential mode

±2 kV common mode

±1 kV differential

mode

±2 kV common

mode

Mains power quality

should be that of a typical

commercial or hospital

environment.

Voltage dips, short

interruptions and

voltage variations on

power supply input

lines

IEC 61000-4-11

<5% UT

(>95% dip in UT)

for 0.5 cycle

40% UT

(60% dip in UT)

for 5 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 0.5 cycle

40% UT

(60% dip in UT)

for 5 cycles

70% UT

(30% dip in UT)

for 25 cycles

<5% UT

(>95% dip in UT)

for 5 sec

Mains power quality

should be that of a typical

commercial or hospital

environment.

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

(50/60 Hz)

magnetic field

IEC 61000-4-8

3 A/m 3 A/m Power frequency

magnetic fields should

be at levels characteristic

of a typical location in a

typical commercial or

hospital environment.

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

LP-30-220 • LEEP PRECISIONTM Smoke Evacuation System, 230 VAC

Operating Manual • English (continued)

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