Surgical Clippers REF 5513E , 5514A , 5514E , 5514U and 5514K Instructions for Use Rev f Feb 2020

en Parts Identification (diagram #1): 1. R  EF 4406, 4403A or 4412A: Disposable blade, single use only REF 4406: General purpose surgical blade designed for all types of hair (light blue) REF 4403A: SensiClip™ surgical blade designed for clipping areas of loose or sensitive skin (light pink) REF 4412A: Neuro surgical blade designed for head hair and/or thick body hair (blue) 2. Clipper handle (REF 5513E) 3. On/Off switch 4. Recharge ( ) LED 5. Charge status ( ) LED 6. C  harging adapter (REF 5514 series): CE marked except REF 5514A. (North America version) Be aware of appropriate plug configuration for your region. Intended Use The BD Surgical Clipper REF 5513E is a rechargeable clipper used with charging adapter (REF 5514 series) and BD disposable blades only (REF 4406, 4403A or 4412A). It is intended to remove head and body hair prior to any medical procedure requiring hair removal. The hair is removed by each blade oscillated by an electric motor. The BD 5513E Clipper will easily and effectively remove body hair and even the thickest hair from the chest with BD disposable blade REF 4406 BD, scalp and other thick coarse hair with BD disposable blade REF 4412A, and other difficult-to-clip areas of the body with BD disposable blade REF 4403A. The Clipper effectively removes wet or dry hair. Charging All Clippers arrive discharged. Before patient use, it is recommended to charge the Clipper a minimum of overnight (Maximum fully charge 17 hours). Switch Clipper off to charge. Place charger upright on a flat surface or wall mount. The charge status ( ) LED glows to indicate it is receiving a charge. Except when charging, it is recommended to unplug the charging adapter from the electrical outlet. This will reduce overall energy consumption and is compliant with best practices. Below are the LED indicators on the Clipper: Orange Solid...Battery is charging Off...Battery is fully charged Blue Flashing...Battery charge low (5 minutes of runtime remaining) Wall mount of charging adapter (diagram #2): The charging adapter can be hung on the wall using wood screws. Place charging adapter per healthcare facility guidelines. 1. Select an appropriate location on the wall where the wall mount can be securely attached. 2. A  ttach the wall mount to the wall as shown with wood screws. • Use no. 6 by 1 inch (25.4mm) round head screws when fixing to wood; or no. 4-6 Molly or Anchor bolts when fixing to sheet rock. 3. Hook the charger onto these screws. 4. Plug the power cord into a power outlet.

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Instructions for use Only trained healthcare personnel should use the Surgical Clipper. If the Surgical Clipper is used for the first time, see the training materials provided by BD. Health care personnel should wear gloves when performing hair removal. Clipper should be disinfected prior to initial use. Suitable for use in healthcare facility environment. Attaching a disposable blade to the Clipper handle (diagram #3): Make sure the Clipper is turned off. Using gloved hands, peel back and remove cover from the blade blister package. Position the new blade on top of the Clipper handle, aligning the mark on the side of the blade with the first line on the handle. Slide the blade back in the direction of the arrow until it clicks into place and the mark on the side of the blade aligns with the dot on the Clipper handle. If blade is dropped or becomes contaminated, discard it. Patient’s skin should be clean. Healthcare professional should instruct patient to avoid sudden movement during clipping process. Use dry or wet clipping method. Choose the appropriate blade depending on the area to clip. Attach blade (see above). Switch Clipper on (diagram #1 – mark 3). Check Clipper and blade for abnormal vibration or noise before patient use. See operating noise specifications listed in the Surgical Clipper specifications table. If abnormalities are found do not use the Clipper. With logo facing up, hold Clipper at approximate 40˚ angle to the patient, (hold between thumb and forefinger with hand underneath, similar to using a pen or a pencil, or with a standard over grip). Glide face of blade gently against surface of skin (diagram #4). For best results clip against the direction of hair growth. It is best to always stretch skin taut for clipping. Removing blade: After clipping, switch Clipper off to stop operation. Position the Clipper blade facing down (diagram #5) over an appropriate trash receptacle, and use your thumb to push the blade forward along the blade frame releasing and disposing of the used blade. Discard blade per facility protocol. Disinfection: Clipper should be disinfected after each use. The Clipper may be rinsed under running water or submerged, for up to 30 minutes, in water to remove any loose hair, debris or other gross contaminants. Cleaning the Clipper can be achieved with a pre-moistened wipe or cloth containing a sodium hypochlorite or hydrogen peroxide solution, following the manufacturer’s instructions for use. Clipper should then be wiped with a pre-moistened disinfectant wipe or cloth moistened with a disinfectant solution. When necessary to clean the charging adapter, disconnect from wall outlet and wipe with the compatible disinfectants as specified for the Clipper. Compatible disinfectants include sodium hypochlorite solution, quaternary ammonium/isopropyl alcohol solution, hydrogen peroxide and benzalkonium chloride/dodecyl dimethyl ammonium chloride/PHMB solutions. Refer to disinfectant instructions for use. Allow Clipper to dry completely before returning to the charging adapter. Disinfectants containing benzyl alcohol can cause chemical damage to the external housing and should not be used for routine cleaning. Use of benzyl alcohol will void the warranty period stated for this product. Should the Clipper become grossly contaminated, discard and contact your local sales representative for a replacement. WARNING: BD blades (REF 4406, 4403A, and 4412A) are single use only and specifically designed for use with the BD 5513E. The user assumes responsibility for appropriate use of this Clipper. Using blades not manufactured or approved by BD will void any warranty and patient results cannot be predicted. Re-use of blades may result in a nonfunctional product and could contribute to cross contamination; potentially putting patient safety at risk.

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Surgical Clipper Specifications:

Surgical Clipper Specifications (continued):

Mode of Operation

Continuous

Waterproofing

IPX7 Rating

BD Disposable Blades Mode of Operation

Single Use

Battery Type

Li-ion 680mAh

Operating Voltage / Current

3.25V DC / 390mA (max.)

Battery Life

Minimum 350 Cycles

Weight

121 grams (4.3 oz.)

Dimension

6.0" (153 mm) H × 1.9" (49 mm) W × 1.5" (39 mm) D

Full Charge Time

Maximum 17 hours

Continuous Run Time (Fully Charged)

Charging Adapter Specifications: Weight

200-250g ± 10g. (7-8.80 Oz.)

Power Source

100–240 V AC; 50–60 Hz, 30mA

Disposable Blades REF 4406 & REF 4403A: Minimum of 80 minutes continuous runtime up to 120 minutes.

Type of Protection Against Electric Shock

Class II

Disposable Blade REF 4412A: Minimum of 50 minutes continuous run-time.

Dimension

3.15" (80 mm) H × 2.40" (61 mm) W × 1.73" (44 mm) D & Cord Length 73.62" (1870 mm)

Ambient Operating Temperature, Humidity, and Atmospheric Pressure

+41 °F (+5 °C) to +95 °F (+35 °C), 30% to 75% RH, 70 to 106 kPa.

Storage Temperature, Humidity, and Atmospheric Pressure

+14 °F (-10 °C) to +140 °F (+60 °C), 10% to 100% RH, 50 to 106 kPa.

Waterproofing

IPX7 Rating

Cord Plug Type

5514A - Type B 5514E - Type F 5514K - Type I 5514U - Type G

Operating Noise

REF 4406 Blade is less than 72dB. REF 4412A Blade is less than 69dB. REF 4403A Blade is less than 75dB.

Type of Protection Against Electric Shock

Internally Powered

Degree of Protection Against Electric Shock

Type B Applied Part

Degree of Protection Against Flammable Anesthetic

Equipment not suitable for use in the presence of a flammable anesthetic.

Ambient Operating Temperature, Humidity, and Atmospheric Pressure

+41 °F (+5 °C) to +95 °F (+35 °C), 30% to 75% RH, 70 to 106 kPa.

Storage Temperature, Humidity, and Atmospheric Pressure

+14 °F (-10 °C) to +140 °F (+60 °C), 10% to 100% RH, 50 to 106 kPa.

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Symbol Explanation: 106 kPa

Catalog Number

Direct current

Authorized representative in the European Community

Atmospheric pressure limitation

Batch Code

Watertight Equipment

Class II (Double Insulation)

Medical Device

Alternating current

Follow operating instructions

10%

-10°C

50 kPa

Unique Device Identifier

On / Off

Do not reuse

Manufacturer

Use By

Operating instructions

100%

Humidity limitation +60°C

Temperature limit

Type B applied part

Information for Users on Collection and Disposal of Old Equipment and used Batteries These symbols on the products, packaging, and/or accompanying documents mean that used electrical and electronic products and batteries should not be mixed with general household waste. For proper treatment, recovery and recycling of old products and used batteries, please take them to applicable collection points, in accordance with your national legislation and the Directives 2002/96/EC and 2006/66/EC. By disposing of these products and batteries correctly, you will help to save valuable resources and prevent any potential negative effects on human health and the environment which could otherwise arise from inappropriate waste handling. For more information about collection and recycling of old products and batteries, please contact your local municipality, your waste disposal service or the point of sale where you purchased the items. Penalties may be applicable for incorrect disposal of this waste, in accordance with national legislation. Information on Disposal in other Countries outside the European Union These symbols are only valid in the European Union. If you wish to discard these items, please contact your local authorities or dealer and ask for the correct method of disposal.

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Caution • The clipper REF 5513E must be used with REF 5514 series charger. • Disposable single use blades (REF 4406, 4403A and 4412A) are designed for optimal use with 5513E only. Using blades not manufactured or approved by BD will void any warranty and patient results cannot be predicted. • Do not submerse Clipper in water or other solution deeper than 3.3 feet (1 m) for no longer than 30 minutes. • Do not plug in with wet hands. Do not connect to charging adapter if clipper is wet. • Keep charging adapter cord away from heated surfaces. • Do not position charging adapter where it is difficult to unplug. • Do not place the Clipper on the charging adapter until charging adapter is seated on a flat surface or securely mounted to a wall. • Prior to charging Clipper ensure charging adapter is free of metallic debris. • Do not use near flammable anesthetic, aerosol spray or oxygen - administering equipment other than nasal or mask types. • Do not expose to hot water, salt water, organic solvents or bleach solutions. • Do not use hydrocarbon or phenol based cleaners or cleaners containing acetone or ketones. • Do not use with damaged blade, handle, or both. • Do not replace supply cord. If supply cord is damaged return to manufacturer or service agent for replacement, to avoid hazard. • Do not sterilize. • Do not take the housing apart as this can affect the watertight construction. • Operating Clipper without blade could lead to injury. • Service or repair must be performed only by qualified repair personnel. Service or repair performed by unqualified personnel may result in a risk of injury, electric shock or fire.

Caution (continued) • Except when charging, it is recommended to unplug the charging adapter from the electrical outlet. This will reduce overall energy consumption and is compliant with best practices. • Do not leave Clipper running without applying to skin for more than 1 minute as blade temperature may exceed 60 °C and potentially leading to thermal injury. • During use, do not keep the Clipper blade applied to the same position of the patient’s skin for longer than 1 minute (these operations may result in blade surface becoming hot). • Inspect treatment site for selection of appropriate blade. If skin irregularities are present, proceed with caution. • In cases of minor injury, seek medical treatment if necessary. • Healthcare personnel should instruct patient to avoid sudden movement during clipping process. Notes • Avoid charging in direct sunlight or near radiating heat. • When not used for extended periods of time, charge every six months to preserve battery life. • Clipper contains a Lithium-ion battery. Dispose of at an officially assigned location, if available. • The battery in this Clipper is not intended to be replaced by users. Diagram #6 is intended only for removal of the chargeable battery for the purpose of proper disposal. • Do not apply Clipper blade to injured skin area.

 ny serious incident that has occurred in relation to the device A should be reported to BD at bd.com and the Competent Authority of the Member State.

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For environmental protection and recycling of materials This Clipper contains a lithium-ion battery. Remove the battery before disposal of the Clipper (#6). When discarding the battery and/or electrical equipment, it should not be mixed with general waste; it must be recycled or disposed of properly according to local regulations. ATTENTION: For the United States: A lithium ion battery that is recyclable powers the product you have purchased. Please call 1-800-8-BATTERY for information on how to recycle this battery.

Limited Warranty: This Surgical Clipper product from BD, REF 5513E and REF 5514 series, is warranted against defects in material and workmanship under normal use for a period of 2 years from the date of purchase. If this product is determined to be defective within the warranty period, it will be repaired or replaced without charge by BD if you contact your local representative or customer service representative who will provide you with the proper authorization, necessary shipping labels and packing list. Please include a description of the defect with the returned unit. This warranty does not cover the replaceable blade unit nor does it cover damage caused by misuse, negligence, accident, or abuse, alteration or modification of the units by any other than BD or its authorized agent, or affixation of any accessory not manufactured or authorized by BD, or use of the Surgical Clipper with current or voltage other than that specified in these instructions. The purchaser assumes responsibility for the safe operation of this Clipper in conjunction with approved and manufactured BD blades (REF 4406, 4403A, and 4412A). Only trained health care professionals or other appropriately trained individuals should use this equipment. BD is not liable in either tort or contract for any cost, expense, loss, or damage whether direct, consequential, special, collateral, or incidental arising out of the use, misuse, or inability to use this product. Except as expressly provided above, BD disclaims all warranties including, but not limited to the implied warranties of merchantability and fitness for particular purpose.

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#6

This equipment has been tested and found to comply with the limits for the medical devices to the IEC 60601‑1‑2, Medical Device Regulation 2017/745/EU. These limits are designed to provide reasonable protection against harmful interference. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to the other devices which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures; - Reorient or relocate the receiving device. - Increase the separation between the equipment. - Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected. - Consult the manufacturer or field service for help.

EMC Information of REF 5513E/5514 series REF 5513E/5514 series needs special precautions regarding EMC and needs to be used according to the following EMC information. WARNING: • Use of REF 5513E/5514 series adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, REF 5513E/5514 series and the other equipment should be observed to verify that they are operating normally. • Use of accessories, other than those specified or provided by the manufacturer of REF 5513E/5514 series could result in increased electromagnetic emissions or decreased electromagnetic immunity of REF 5513E/5514 series and result in improper operation. • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of REF 5513E/5514 series, including cables specified by the manufacturer. Otherwise, degradation of the performance of REF 5513E/5514 series could result.

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Guidance and manufacturer’s declaration - electromagnetic emissions REF 5513E/5514 series is intended for use in the electromagnetic environment specified below. The customer or the user of REF 5513E/5514 series should insure that it is used in such an environment. Emission test

Compliance

RF emissions CISPR 11

Group 1

RF emissions CISPR 11

Class B

Harmonic emissions IEC 61000‑3‑2

Class A

Voltage fluctuations/ flicker emissions IEC 61000‑3‑3

Complies

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Electromagnetic environment - guidance REF 5513E/5514 series 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.

REF 5513E/5514 series is suitable use in all establishments, including domestic establishments and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes.

Guidance and manufacturer’s declaration - electromagnetic immunity REF 5513E/5514 series is intended for use in the electromagnetic environment specified below. The customer or the user of REF 5513E/5514 series should insure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance

Electrostatic discharge (ESD) IEC 61000‑4‑2

±8 kV contact ±2/4/8/15 kV air

±8 kV contact ±2/4/8/15 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%.

Electrical fast transient/burst IEC 61000‑4‑4

±2 kV for power supply lines 100kHz repetition frequency

±2 kV for power supply lines 100kHz repetition frequency

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

Surge IEC 61000‑4‑5

±0.5/1kV line to line

±0.5/1kV line to line

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

0% UΤ; 0.5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270°and 315° 0% UΤ; 1 cycle and 70% UΤ; 25/30 cycles Single phase: at 0° 0% UΤ: 250/300 cycle

0% UΤ; 0.5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270°and 315° 0% UΤ; 1 cycle and 70% UΤ; 25 cycles Single phase: at 0° 0% UΤ: 250 cycle

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

Power frequency (50/60 Hz) magnetic field IEC 61000‑4‑8

30 A/m 50 Hz/60Hz

30 A/m 50 Hz/60Hz

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

Note: UΤ is the a.c. mains voltage prior to application of the test level

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Guidance and manufacturer’s declaration - electromagnetic immunity REF 5513E/5514 series is intended for use in the electromagnetic environment specified below. The customer or the user of REF 5513E/5514 series should insure that it is used in such an environment.

Immunity test

Conducted RF IEC 61000‑4‑6

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance

3V 0.15MHz-80MHz 6V in ISM bands between 0.15MHz and 80MHz 80% AM at 1 kHz

3V 0.15MHz-80MHz 6V in ISM and amateur radio bands between 0.15MHz and 80MHz 80% AM at 1 kHz

Portable and mobile RF communications equipment should be used no closer to any part of REF 5513E/5514 series, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2 √P d = 0.35√P 80MHz to 800MHz d = 0.7√P 800MHz to 2.7GHz

Radiated RF IEC 61000‑4‑3

3V/m 80MHz-2,7GHz 80% AM at 1 kHz

10V/m 80MHz-2,7GHz 80% AM at 1 kHz

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 strength from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

Proximity fields from RF wireless communications equipment IEC 61000-4-3

IEC 60601-2: 2014 Table 9

IEC 60601-1-2: 2014 Table 9

d = 6/E√P 380MHz to 5.8GHz

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.

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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 REF 5513E/5514 series is used exceeds the applicable RF compliance level above, REF 5513E/5514 series should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating REF 5513E/5514 series. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distance between portable and mobile RF communications equipment and REF 5513E/5514 series REF 5513E/5514 series is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of REF 5513E/5514 series can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and REF 5513E/5514 series as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W

Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d = 1.2 √P

80 MHz to 800 MHz d = 0.35 √P

800 MHz to 2.7 GHz d = 0.7 √P

0.01

0.12

0.035

0.07

0.1

0.38

0.11

0.22

1

1.2

0.35

0.7

10

3.8

1.1

2.2

100

12

3.5

7

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 power rating of the transmitter in watts (W) according to the transmitter manufacturer. 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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IEC 60601-1-2: 2014, Table 9 Band (MHz)

14

Service

Maximum power (W)

Distance (m)

Immunity Test Level (V/m)

380-390

TETRA 400

1.8

0.3

27

430-470

GMRS 460, FRS 460

2

0.3

28

704-787

LTE Band 13, 17

0.2

0.3

9

800-960

GSM 800/900 TETRA 800, iDEN 820, CDMA 850, LTE Band 5

2

0.3

28

1700-1990

GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS

2

0.3

28

2400-2570

Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7

2

0.3

28

5100-5800

WLAN 802.11 a/n

0.2

0.3

9

IEC 60601-1-2: 2014, tabel 9 Bånd (MHz)

110

Service

Maksimal effekt (W)

Afstand (m)

Immunitetstestniveau (V/m)

380-390

TETRA 400

1,8

0,3

27

430-470

GMRS 460, FRS 460

2

0,3

28

704-787

LTE-bånd 13, 17

0,2

0,3

9

800-960

GSM 800/900 TETRA 800, iDEN 820, CDMA 850, LTE-bånd 5

2

0,3

28

1700-1990

GSM 1800; CDMA 1900; GSM 1900; DECT; LTE-bånd 1, 3, 4, 25; UMTS

2

0,3

28

2400-2570

Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE-bånd 7

2

0,3

28

5100-5800

WLAN 802.11 a/n

0,2

0,3

9

Made in Japan 36-10431 Rev. F Becton, Dickinson and Company 75 North Fairway Drive Vernon Hills, IL 60061 USA BD Switzerland Sàrl Terre Bonne Park – A4 Route de Crassier 17 1262 Eysins, Switzerland BD, the BD Logo, and SensiClip are trademarks of Becton, Dickinson and Company or its affiliates. ©2020 BD. All rights reserved.

Becton Dickinson Pty Ltd. 4 Research Park Drive North Ryde, NSW, 2113, Australia Becton Dickinson Limited 14B George Bourke Drive Mt. Wellington, Auckland, 1060 New Zealand Sponsored in Australia and New Zealand by BD. bd.com bd.com/surgeryifu bd.com/symbols-glossary

Issuance Date: 2020.02.05