Model 9681 Instructions July 2015

3M™ Surgical Clipper Professional 9681

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SAVE THESE INSTRUCTIONS Important Safety Instructions When using this clipper and its accessories, basic precautions should always be followed. Read and understand all safety information before using.

Product Description The 3M™ Surgical Clipper Professional, 9681, is a cordless, rechargeable, battery-operated clipper which is comprised of a clipper body, drop-in charger stand with cord (REF 9682)* and single-use blade assembly (REF 9680). *9683, 9684 and 9685 Additional Drop-in Chargers with Cords

INTENDED USE The 3M™ Surgical Clipper Professional, 9681, is intended to remove body hair and head hair from patients in preparation for any medical procedure requiring hair removal.

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WARNING

CAUTION

To reduce the risks associated with fire and explosion, which if not avoided could result in serious injury or death and/or property damage:

To reduce the risks associated with fire, and hazardous voltage, which if not avoided may result in minor or moderate injury and/or property damage:

•

• • • • • • • • •

• •

Do not operate clipper where aerosol (spray) products, flammable anesthetic mixture with air, nitrous oxide or oxygen administering equipment other than nasal or mask types are being used. Emergency Medical Technicians (EMTs), do not use clipper on a patient whose clothing is saturated with flammable solutions such as gasoline, fuel oil, solvents, etc. Avoid using around flammable alcohol or similar cleaning solution. If alcohol is used to clean the clipper, assure that the clipper and surrounding area is ventilated of fumes before plugging in the drop-in charger with cord or switching on the clipper.

To reduce the risks associated with hazardous voltage, which if not avoided could result in death or serious injury: • • • • • • • • • •

Do not attempt to plug or unplug the drop-in charger with cord from an electrical outlet with wet hands. Unplug the drop-in charger cord before cleaning. Do not place or store a drop-in charger with cord where it can fall or be pulled into a tub or sink of water. Do not retrieve a drop-in charger with cord that has fallen into or is submerged in water or other solutions. Unplug cord from the wall outlet immediately. Never charge the clipper if the drop-in charger has a damaged cord or plug; if it is not working properly, if it has been dropped or damaged, or if the drop-in charger has been dropped into water. Do not put in fire or mutilate the battery pack during disposal as it may burst or release toxic materials. Do not short circuit the battery pack by bridging the battery contacts with a metal or conductive part as it may cause burns. Do not attempt to replace the battery pack. This could result in the risk of fire or electric shock. Do not charge the clipper within 1.5 meters (4.9 feet) of the patient. Do not charge near water.

To reduce the risks associated with cross contamination, which if not avoided could result in death or serious injury: • •

Do not reuse the clipper blade assembly. Single patient use only. Always clean the clipper body between patients.

• • •

Do not sterilize the clipper body, drop-in charger with cord, or blade assembly. Only use attachments recommended by the manufacturer. Always store the clipper and drop-in charger with cord in a moisture-free area. Do not attempt to replace the battery in the clipper. Do not tamper with the device’s internal components. There are no user serviceable parts inside this device. Do not charge the clipper outdoors. Keep drop-in charger with cord away from heated surfaces. See rating plate on drop-in charger cord unit for proper wall outlet voltage. This device may cause (EMI) Electromagnetic Interference. If this occurs, separate product from affected device. The use of accessories other than those specified may result in increased emissions or decreased immunity of the clipper. Do not submerse the clipper in water or other solution deeper than 6 inches or longer than 15 minutes. Do not dismantle the clipper during the useful life of the clipper for this can affect the watertight construction of the clipper.

To reduce the risk associated with environmental contamination, which if not avoided may result in minor or moderate injury: • • •

At the end of product life, dispose of all components in accordance with your governmental regulations. Dispose of batteries properly in accordance with your local, state, and/or government requirements. Do not tamper with the device’s internal components. There are no user-serviceable parts inside this device.

To reduce the risks associated with skin nicks and lacerations, which if not avoided may result in minor or moderate injury: • • •

Do not use the clipper with a damaged or broken clipper blade assembly. Do not clip in a raking manner as this technique may damage the patient’s skin. Blade temperature can reach upwards of 50°C (122°F) after prolonged use.

PURCHASER’S RESPONSIBILITY Only health care professionals or other appropriately trained individuals should use this equipment.

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MECHANICAL ART

9300 WINNETKA AVE N, BROOKLYN PARK, MN 55445, 763.488.5700 DESC: 3M™ - Surgical Clipper Professional 9681 - Insert CHANGES Item Spec. #: 34-8717-5427-0 DATE Supersedes #: 34-8712-4479-3

PU Supersedes (SGS 3615898). Update per markup. 07.31.15 Final release.

Proof prepared for 3M Company

REV. 00 INT. SRWv TN

Structure #:

K Printed Colors-Back: 1

K

Reference: 9681

Notes to Printer:

Requesters: Scott Keppers DIE #: 8" x 5.5" Spread

Created in Adobe InDesign CS5 Printed Colors-Front: 1

SGS#: 4149096 FILE: 34871754270.indd

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This bar code symbol was produced using a bar width adjustment of minus 0.004. If this does not Because of the differences in scanning equipment, SGS Minnesota cannot guarantee the scannability Bar Code Special Instructions: Magnification: meet the needs of the printing process or equipment to be used, the printer is responsible to recreate of UPC Bar codes. The Uniform Code Council recommends a UPC symbol be printed black on white the file using the appropriate bar width adjustment while meeting 3M quality requirements. at 100% with no truncation. All UPC codes are test scanned and verified before leaving our facility. XXX%

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Match Colors: 0

Explanation of Symbols Caution – see instructions for use Equipment Switch “On” Equipment Switch "Off"

INSTRUCTIONS FOR USE Consult instructions for use Class II Equipment

Type B Applied Part

Use Indoors

Fail-safe Transformer

Splash Proof

Direct Current

Do Not Reuse

Non-Sterile

Keep Dry

To Attach a Disposable Blade to the Clipper Body: Make sure that the ON/OFF button is in the OFF position. After removing the lid of the clipper blade assembly blister pack and without touching the blade assembly, hold the clipper body over the clipper blade assembly (a). Slide the new clipper blade assembly into position until it clicks (b).

To Use the Clipper: The patient’s skin should be clean. To turn the clipper on, simply push the ON/OFF button above the LED battery gauge on the clipper to the ON position. The power indicator will light up to the corresponding battery capacity (c). LED Battery Gauge Operation The top three LED light gauges will be green and the bottom two will be yellow. These gauges indicate battery capacity. See (d) below. NOTE: When battery level is low, the lowest LED will blink indicating re-charge is needed. The LEDs will also blink when in the charge stand indicating that the clipper is charging. The level of charge can be determined by the light that is blinking at that time. Percent of Charge

Temperature Limitation

The disposal of Li-ion batteries as municipal solid waste is prohibited

Recycle in accordance with your local, state, and/or government requirements.

Storage Storage and transport conditions: -20°C to +50°C; -4°F to +122°F; 10% to 100% RH, 50 to 106kPa Operation conditions: +0°C to +40°C; 32°F to +104°F; 30% to 75% RH, 70 to 106kPa

a.

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c.

80-100%

REE

60-80%

REE

40-60%

ELLO

20-40%

ELLO

0-20%

d.

Use short, gentle strokes, holding the clipper blade assembly at a flat to slight angle to the patient’s skin (e). For best results, clip against the direction of the hair growth. For contoured areas, stretch the skin taut while clipping. There are several ways to grasp the clipper. Determine the most comfortable technique that allows you to keep the clipper blade assembly at a flat to a slight angle to the skin. This technique can be performed in a push or pull motion. Never rake the clipper over the skin (f).

e.

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b.

REE

f.

g.

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To Change Disposable Blade:

9681 Battery Pack Removal

Push the ON/OFF button into the OFF position. Hold the clipper body in one hand. Position the clipper over an appropriate waste receptacle with the blade facing downward. With your thumb, push the blade release button to push the blade off the clipper body into waste receptacle (g).

The clipper body contains recyclable Lithium-Ion (Li-Ion) batteries, which are not intended to be replaced. When your rechargeable clipper reaches the end of its useful life, the battery pack must be removed from the clipper and be recycled or disposed of properly in accordance with your local, state, and/or government requirements. The disposal of Li-ion batteries as municipal solid waste is prohibited.

NOTE: To reduce cross contamination between patients, remove the clipper blade assembly and discard appropriately after each use.

Care and Cleaning of the Clipper Body:

The procedure below describes the removal of the battery pack for the purpose of proper disposal. Discard the clipper after the battery pack has been removed.

The housing of the clipper body is made of durable plastic and is water resistant. It may be wiped off with a damp cloth containing a small amount of alcohol, disinfectant, or a mild detergent solution. It can also be rinsed under running water or submersed in a high level disinfectant solution. Approved chemicals for use in cleaning include 70% alcohol, 2% bleach, Alkaline Gluteraldehyde, Quaternary ammonium chloride, or Chlor-clean solution. Allow to dry completely before placing clipper back into drop-in charger or reusing. Do not sterilize the clipper body or blade assembly.

Charging the 9681 Battery-Operated Clipper: h.

To charge the clipper: 1. Push the ON/OFF button to the OFF position. 2. Clean the clipper body before returning clipper to the drop-in charger, making sure the clipper and charger contacts are clean and free of hair or other contaminants. 3. Connect the cord of the drop-in charger to an appropriate electrical outlet, making sure the cord is not pinched or kinked. 4. To be certain that the 9681 clipper is fully charged, plug it in for 3 hours before its initial use and every use thereafter. 5. We recommend leaving the clipper body in the drop-in charger in between uses. It cannot be overcharged.

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1. 2. 3. 4. 5. 6. 7. 8.

i.

j. k.

Make sure that the ON/OFF button is in the OFF position. Remove disposable clipper blade assembly. Dry clipper and hands completely. Remove the three housing screws (h). Pull or pry the top and bottom housing apart from the top (i). Pull motor and battery pack out. (j) Pull Li-ion battery out of the assembly (k) Recycle battery pack or dispose of appropriately.

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Components/Accessories

9681 Clipper Specifications Motor Voltage:

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1.0 amps max.

Current with full load:

1.3 amps max.

RPM:

5500-6000

Power Adapters Charge Circuits:

All power adapters/charge circuits are 100-240 VAC, 50-60Hz.

Charging Time:

3 hours

Battery Operating Time:

160 minutes

Battery:

Lithium-Ion (Li-ion)

Clipper Weight (with blade):

180 grams (6.7 oz)

Clipper Dimensions (with blade): 3 1. 9681 3M™ Surgical Clipper Professional 2. 9680 3M™ Clipper Blade Assembly 3. 9682 3M™ Drop-in Charger Stand with cord (Plug Type A)* 9683 3M™ Drop-in Charger Stand with cord (Plug Type C) 9684 3M™ Drop-in Charger Stand with cord (Plug Type G) 9685 3M™ Drop-in-Charger Stand with cord (Plug Type I) *Not CE Marked NOTE: The 9680 3M™ Clipper Blade Assembly is the only acceptable blade to be used on the 9681 3M™ Surgical Clipper Professional.

3.6 volt DC

Current without load:

15.5 cm (6.1 in.) Length 4.3 cm (1.69 in.) Diameter

THE DEVICE HAS BEEN TESTED IN ACCORDANCE WITH IEC 60601‑1 MEDICAL – GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE MEDICAL. This device complies with the requirements of European Medical Device Directive 93/42/EEC.

Warranties/3M Liability Limited Warranty This warranty is in lieu of any other warranty express or implied except as indicated below: This 3M™ Surgical Clipper Professional is warranted against any defects in material or workmanship for a period of 2 years from the date of purchase. If this surgical clipper is determined to be defective within the warranty period, it will be replaced without charge by 3M. In the U.S., contact your local 3M Sales Representative or the 3M Health Care Helpline – 1 800 228.3957. Helpline personnel are available Monday through Friday, from 7:00 AM to 6:00 PM Central Time. After business hours, a voice prompt system will take your product complaint information. International customers, please contact your local 3M Subsidiary for necessary shipping labels and packing list. Please include a description of the defect with the returned unit. This warranty does not cover damage caused by misuse, negligence, accident, abuse or alteration, modification of the units by anyone other than 3M or affixation of any accessory not manufactured by 3M, or use of the surgical clipper with current or voltage other than that specified in this instruction insert. Replacements after the warranty period will be made and charged to the customer on the basis of rates which are available upon request. EXCEPT FOR PERSONAL INJURY, 3M IS NOT LIABLE IN EITHER TORT OR CONTRACT FOR ANY LOSS OR DAMAGE, DIRECT, CONSEQUENTIAL, OR INCIDENTAL ARISING OUT OF THE USE, MISUSE, OR INABILITY TO USE THIS PRODUCT. All implied warranties are limited in duration to 2 years from date of original purchase. This warranty does not apply to Australia and New Zealand. Customers should rely on their statutory rights.

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IEC 60601-1-2 2nd and 3rd Edition Guidance Tables Table 201 / Table 1 (2nd / 3rd Edition, Respectively) Guidance and Manufacturer’s Declaration – Emissions All Equipment and Systems Guidance and Manufacturer’s Declaration - Emissions The 3M™ Surgical Clipper Professional, 9681 is intended for use in the electromagnetic environment specified below. The customer or user of the 3M™ Surgical Clipper Professional, 9681 should ensure that it is used in such an environment. Emissions Test

Compliance

Electromagnetic Environment – Guidance

RF Emissions CISPR 11

Group 1

The 3M™ Surgical Clipper Professional, 9681 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF Emissions CISPR 11

Class B

Harmonics IEC 61000-3-2

Class A

Flicker IEC 61000-3-3

Complies

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The 3M™ Surgical Clipper Professional, 9681 is suitable for use in all establishments, including domestic, and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Table 202 / Table 2 (2nd / 3rd Edition, Respectively) Guidance and Manufacturer’s Declaration – Immunity All Equipment and Systems Guidance and Manufacturer’s Declaration – Immunity The 3M™ Surgical Clipper Professional, 9681 is intended for use in the electromagnetic environment specified below. The customer or user of the 3M™ Surgical Clipper Professional, 9681 should ensure that it is used in such an environment.

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment – Guidance

ESD IEC 61000-4-2

±6kV Contact ±8kV Air

±6kV Contact ±8kV Air

Floors should be wood, concrete or ceramic tile. If floors are synthetic, the r/h should be at least 30%

EFT IEC 61000-4-4

±2kV Mains ±1kV I/Os

±2kV Mains No I/O lines

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

Surge IEC 61000-4-5

±1kV Differential ±2kV Common

±1kV Differential ±2kV Common

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

Voltage Dips/Dropout IEC 61000-4-11

>95% Dip for 0.5 Cycle 60% Dip for 5 Cycles 30% Dip for 25 Cycles >95% Dip for 5 Seconds

>95% Dip for 0.5 Cycle 60% Dip for 5 Cycles 30% Dip for 25 Cycles >95% Dip for 5 Seconds

Mains power quality should be that of a typical commercial or hospital environment. If the user of the 3M™ Surgical Clipper Professional, 9681 requires continued operation during power mains interruptions, it is recommended that the 3M™ Surgical Clipper Professional, 9681 be powered from an uninterruptible power supply or battery.

Power Frequency 50/60Hz Magnetic Field IEC 61000-4-8

3A/m

3A/m

Power frequency magnetic fields should be that of a typical commercial or hospital environment.

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Table 204 / Table 4 (2nd / 3rd Edition, Respectively)

Table 206 / Table 6 (2nd / 3rd Edition, Respectively)

Guidance and Manufacturer’s Declaration – Immunity Equipment and Systems that are NOT Life-supporting

Recommended Separation Distances between portable and mobile RF Communications equipment and the 3M™ Surgical Clipper Professional, 9681 Equipment and Systems that are NOT Life-supporting

Guidance and Manufacturer’s Declaration – Emissions The 3M™ Surgical Clipper Professional, 9681 is intended for use in the electromagnetic environment specified below. The customer or user of the 3M™ Surgical Clipper Professional, 9681 should ensure that it is used in such an environment.

Immunity Test

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

IEC 60601 Test Level

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

Compliance Level

(V1) = 3Vrms

(E1) = 3V/m

Electromagnetic Environment – Guidance Portable and mobile communications equipment should be separated from the 3M™ Surgical Clipper Professional, 9681 by no less than the distances calculated/listed below: D=(3.5/V1)(Sqrt P) D=(3.5/E1)(Sqrt P) 80 to 800 MHz D=(7/E1)(Sqrt P) 800 MHz to 2.5 GHz Where P is the max power in watts and D is the recommended separation distance in meters. Field strengths from fixed transmitters, as determined by an electromagnetic site survey, should be less than the compliance levels (V1 and E1). Interference may occur in the vicinity of equipment containing a transmitter.

Recommended Separations Distances for the 3M™ Surgical Clipper Professional, 9681 The 3M™ Surgical Clipper Professional, 9681 is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the 3M™ Surgical Clipper Professional, 9681 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the 3M™ Surgical Clipper Professional, 9681 as recommended below, according to the maximum output power of the communications equipment.

Max Output Power (Watts)

Separation (m) 150kHz to 80MHz D=(3.5/V1)(Sqrt P)

Separation (m) 80 to 800MHz D=(3.5/E1)(Sqrt P)

Separation (m) 800MHz to 2.5GHz D=(7/E1)(Sqrt P)

0.01

0.11667

0.11667

0.23333

0.1

0.36894

0.36894

0.73785

1

1.1667

1.1667

2.3333

10

3.6894

3.6894

7.3785

100

11.667

11.667

23.333

Made in China for 3M Health Care 2510 Conway Avenue St. Paul, MN 55144 U.S.A. 1-800-228-3957 www.3M.com © 2015, 3M. All rights reserved. 3M is a trademark of 3M. Used under license in Canada. 12

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