Model 9661L Instructions Sept 2019

Directions for Use

• There are no known reciprocal interferences posed by use of this medical equipment in environments intended for use. • In case of liquid spills in the patient’s environment that may come in contact with the medical equipment, immediately clean the medical equipment according to the care and cleaning Instructions contained in this manual. • 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. Caution- 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. • Do not use the Specialty Blade Assembly 9690 in sensitive areas such as the scrotum and axilla.

A. To Attach a Disposable Blade Assembly (9660 or 9690) onto the Clipper Body: • Make sure that the ON/OFF switch is in the OFF position. • Hold the clipper body at a 45° (degree) angle over the opened blade assembly package. Push the clipper body into the blade to secure. An audible snap indicates blade assembly is securely attached. B, C. To Use the Clipper: • The patient’s skin should be clean. To turn the clipper on, slide the ON/OFF switch to the ON position. Use short gentle strokes with either blade set to remove hair effectively. • Surgical Clipper Blade Assembly (9660): The Surgical Clipper Blade Assembly should be held flat or at a slight angle to the patient’s skin (B). For best results, clip against the direction of the hair growth. For sensitive skin areas, stretch the skin taut while clipping. The Surgical Clipper Blade Assembly is able to pivot while on the 3M™ Surgical Clipper 9661L with Pivoting Head. • Specialty Blade Assembly (9690): The Specialty Blade Assembly, designed for head and heavy body hair, should be held flat to the patient’s skin (C). The Specialty Blade Assembly is NOT able to pivot while on the 3M™ Surgical Clipper 9661L with Pivoting Head. DO NOT use Specialty Blade Assembly 9690 in sensitive areas such as the scrotum and axilla. D. To Remove Disposable Blade Assembly (9660 or 9690): • Ensure the ON/OFF switch is in the OFF position. • Position the clipper over an appropriate waste receptacle with the blade assembly facing downward. • Use your thumb to push blade assembly off the clipper body into an approved waste receptacle. E, F. Care and Cleaning of the Clipper Body: • The housing of the clipper body is made of durable plastic and is water resistant. The clipper may be rinsed under running water or submerged, up to 30 minutes, in water to remove any loose hair or debris (E) (F). • For disinfection, clipper should be wiped with a pre-moistened disinfectant wipe or cloth moistened with disinfectant solution. • Allow to dry completely before returning to drop-in charger stand with cord or reusing. • Do not sterilize the clipper body, blade assembly, or drop-in charger stand with cord. • Compatible disinfectants include: 70% isopropyl alcohol, 1:10 bleach solution, quaternary ammonium germicidal detergent, and 3% hydrogen peroxide (follow product labels for proper dilution). • No parts of the clipper require servicing during use.

User Responsibility

Only health care professionals should use this equipment.

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 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. There are no serviceable or replacement parts available for repair. In the U.S., contact your local 3M sales representative or the 3M Health Care Helpline at: 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. For customers outside of the United States, please contact your local 3M sales representative 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. 2

The procedure below describes the removal of the battery for the purpose of proper disposal. Discard the clipper after the battery has been removed. 1. Make sure that the ON/OFF switch is in the OFF position. 2. Remove disposable blade assembly 3. Dry clipper and hands completely 4. Remove screws from back of clipper body using a small Phillips head screwdriver 5. Separate top and bottom clipper housings 6. Remove battery by snipping battery wire 7. Recycle or dispose of battery appropriately

Charging the 9661L Clipper: 1. Plug the drop-in charger stand with cord into an appropriate electrical outlet, making sure the cord is not pinched, kinked or damaged. 2. Clean the clipper body before returning the clipper to the charger with cord, making sure the clipper and the charger contacts are clean, dry, and free of hair and other contaminants. 3. To start charging, slide the clipper power switch to the OFF position and place the clipper into the drop-in charger stand with cord. • A flashing AMBER indicator light indicates clipper is charging. The indicator will return to a steady GREEN light indicating a full charge condition. • Charge time is approximately 4 hours from a fully depleted status. 4. In use, the clipper indicator light remains GREEN. Charge the clipper when the GREEN light turns to flashing AMBER. Once GREEN light turns to flashing AMBER light, there is approximately 10 minutes of clipping time remaining. Note: When charging, if the AMBER indicator light fails to FLASH proceed with the following items: • Check to be sure drop-in charger stand with cord is free of hair or debris. • Wiggle the clipper body until proper contact has been made with the clipper terminals. • Wipe electrical contacts with alcohol and allow them to dry before reinserting the clipper body into the drop-in charger stand with cord. • Check to ensure that corded charge stand MAINS power plug is properly connected. Installation of drop-in charger stand with cord: The drop-in charger stand with cord is designed with rubber feet to sit on a flat surface such as a counter/desk top. Alternatively, it may be mounted flush to a wall by two #6 (3.5mm) screws, spaced vertically at 1.58” (40mm).

How supplied

1. Disposable Blade Assembly (9660 or 9690) APPLIED PART 2. ON/OFF Switch 3. Clipper Body (9661L) 4. Indicator Light 5. Drop-in charger stand with cord

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3M™ Surgical Clipper 9661L with Pivoting Head Components 9660 Surgical Clipper Blade Assembly 9690 Specialty Blade Assembly 9661L Surgical Clipper with Pivoting Head 3M™ Surgical Clipper 9661L with Pivoting Head Accessories 9662L Drop-in charger stand with cord 120V, 60Hz (Plug Type A) 9663L Drop-in charger stand with cord 240V, 50Hz (Plug Type I) 9665L Drop-in charger stand with cord 230V, 50-60Hz (Plug Type G) 9668L Drop-in charger stand with cord 230V, 50-60Hz (Plug Type C) 3M™ Surgical Clipper 9661L with Pivoting Head Components and Accessories 9667L Starter Kit, includes 9661L and 9662L 9667L-A Starter Kit, includes 9661L and 9663L 9667L-E Starter Kit, includes 9661L and 9668L

Storage/ Shelf Life/Disposal

Storage and Temperature Limitations Storage & Transportation Temperatures: 35°C -20°C (-4°F) to +35°C (95°F) 95°F 10% to 100% RH -20°C 50 to 106kPa (7.25 – 15.37 psi) -4°F Operating Conditions: 0°C (32°F) to +35°C (95°F) 10% to 100% RH 76 to 106kPA (11.02 – 15.37 psi) Battery Removal: The clipper body contains a recyclable Lithium-ion (Li-ion) battery that is not intended to be replaced. When your rechargeable clipper reaches the end of its expected service life (~500 hours), the battery 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. For additional information in the U.S.A., call 1-800-822-8837. 3

Technical Specifications Power Supply Output: Motor Voltage:

Charge Current: Running Current: Charging Time: Battery Operating Time: Clipper Weight: Clipper Dimensions:

5.0 Vdc, 1200mA 3.6 Volts DC Current without load: 1000 mA max. Current with motor stalled: 3.5 amps max. 500-1300 milliamps 700 mA 4 hours initial, 4 hours thereafter 160 minimum minutes 144 grams (5 oz.) 16.1 cm (6.34 in) Height – with 9660 blade 17.5 cm (6.89 in) Height – with 9690 blade 4.1 cm (1.6 in) Width – with 9660 blade 5.1 cm (2.0 in) Width – with 9690 blade 4.1 cm (1.6 in) Width – 9661L body 14.2 cm (5.6 in) Height – 9661L body 12.7 cm (5.0 in) Circumference – 9661L body

The device has been tested in accordance with ANSI/AAMI ES60601-1:2005/(R) 2012, CAN/CSA-C22.2 NO. 60601-1:14, IEC 60601-1:2005 + A1: 2012 Medical Electrical Equipment – General Requirements for Basic Safety and Essential Performance. The device (including components and accessories) bearing the CE mark complies with the requirements of the Medical Device Directive 93/42/EEC, as amended per 2007/47EC.

Table 2 Guidance and Manufacturer’s Declaration Guidance and manufacturer’s declaration – electromagnetic immunity The Model 9661L is intended for use in the electromagnet environment specified below. The customer or the end user of the Model 9661L should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Floors should be wood, concrete or ceramic tile. +8 kV contact Electrostatic discharge (ESD) +8 kV contact If floors are covered with synthetic material, the +15 kV air +15 kV air IEC 61000-4-2 relative humidity should be at least 30%. +2 kV for power +2 kV for power Mains power quality should be that of a typical Electrical fast transient/burst supply lines supply lines commercial or hospital environment. IEC 61000-4-4 +1 kV for input/output lines +1 kV for input/output lines Surge IEC 61000-4-5

+1 kV differential mode +2 kV common mode

+1 kV differential mode +2 kV common mode

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

>95% dip in 0.5 cycle 60% dip in 5 cycles 30% dip for 25 cycles >95% dip in 5 seconds 0% dip in 1 cycles 0% dip in 0.5 cycles@0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°

>95% dip in 0.5 cycle Mains power quality should be that of a typical 60% dip in 5 cycles 30% commercial or hospital environment. dip for 25 cycles If the user of the Model 9661L requires >95% dip in 5 seconds continued operation during very long power 0% dip in 1 cycles mains interruptions, it is recommended 0% dip in 0.5 cycles@0°, that the Model 9661L be powered from an 45°, 90°, 135°, 180°, 225°, uninterruptible power supply or battery. 270° and 315°

Power frequency (50/60 Hz) magnetic field 30 A/m 30 A/m IEC 61000-4-8 NOTE: UT is the a.c. mains voltage prior to application of the test level.

Table 1 Guidance and Manufacturer’s Declaration Guidance and manufacturer’s declaration tables - Electromagnetic Emissions The Model 9661L is intended for use in the electromagnetic environment specified below. The customer or user of the Model 9661L device should ensure that it is used in such an environment. Emissions test Compliance Electromagnetic environment – guidance The Model 9661L uses RF energy only for its internal function. RF emissions Group 1 Therefore, its RF emissions are very low and are not likely to cause CISPR 11 any interference in nearby electronic equipment RF emissions CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/flicker emissions IEC 61000-3-3

Complies

The Model 9661L is 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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Mains power quality should be that of a typical commercial or hospital environment.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Table 4 Guidance and Manufacturer’s Declaration Guidance and manufacturer’s declaration - electromagnetic emissions The Model 9661L is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 9661L should assure that it is used in such an environment. Immunity test IEC 60601 Compliance level Electromagnetic environment - guidance test level Portable and mobile RF communications equipment should be used no closer to any part of the Model 9661L, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. c 3 Vrms Recommended separation distance 3 Vrms D = 1.17 √P Conducted RF 150 kHz to 10 V/m from IEC 61000-4-6 80 MHzc D = 1.17 √P (80 MHz to 800 MHz) 30MHz to 1GHz, D = 2.33 √P (800 MHz to 2.7 GHz) 10 V/m for 10 V/m Radiated RF IEC where P is the maximum output power rating of the transmitter in watts 1GHz to 2.7 GHz; 80 MHz to 61000-4-3 (W) according to the transmitter manufacturer and d is the recommended (1000 Hz. 80% 2.7 GHz Modulated Test Signal) 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: 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. 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 broadcast and TV broadcast 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 Model 9661L is used exceeds the applicable RF compliance level above, the Model 9661L should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Model 9661L. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. c 6 V RMS was applied in the ISM and amateur radio bands, (see note 2 on subsequent page).

Table 6 Guidance and Manufacturer’s Declaration Recommended separation distance between Portable and mobile RF communications equipment and the Model 9661L The Model 9661L is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Model 9661L can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Model 9661L as recommended below, according to the maximum output power of the communications equipment. Separation Distance According to Frequency of Transmitter (m) Rated Max. Output Power of 800 MHz to 2.7 GHz **150 kHz to 80 MHz 80 MHz to 800 MHz Transmitter (W) d =1.17 √P d = 2.33 √P d = 1.17 √P (E1=10) (V1=3) (E1=10) 0.01 0.12 0.04 0.07 0.1 0.37 0.11 0.22 1 1.17 0.35 0.70 10 3.70 1.11 2.21 100 11.70 3.50 7.00 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. **See Note 2, (below): 6 V RMS was applied in the ISM and amateur radio bands. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz NOTE 3 An additional factor of 10/3 has been incorporated into the formulae used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2,5 GHz to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. NOTE 4 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Please report a serious incident occurring in relation to the device to 3M and the local competent authority (EU) or local regulatory authority.

Explanation of Symbols: Symbol Title

“OFF” (power) “ON” (power)

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Symbol

Description and Reference

To indicate disconnection from the mains, at least for main switches, or their positions, and all those cases where safety is involved. Source: IEC 60417, 5008 To indicate connection to the mains, at least for mains switches, or their positions, and all those cases where safety is involved. Source: IEC 60417, 5007

Atmospheric pressure limitation

Indicates the range of atmospheric pressure to which the medical device can be safely exposed. ISO 15223, 5.3.9

Authorized Representative in European Community

Indicates the authorized representative in the European Community. ISO 15223, 5.1.2

Catalogue number

Indicates the manufacturer's catalogue number so that the medical device can be identified. ISO 15223, 5.1.6

Caution

Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself. Source: ISO 15223, 5.4.4

CE Mark

Indicates conformity to European Union Medical Device Regulation or Directive.

Class II equipment

To identify equipment meeting the safety requirements for Class II equipment per IEC 61140. Source: IEC/TR 60878

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Printed Colors – Front:

Requester: Creator: File Name: Structure #: Date:

Susan Barker deZinnia_26550.1 34872482673.indd SS-84941 12/09/19

Printed Colors – Back: Match Colors:

This artwork has been created as requested by 3M. 3M is responsible for the artwork AS APPROVED and assumes full responsibility for its correctness.

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