BD 5513E User manual

5513E / 5514A / 5514E / 5514U / 5514K
Instructions For Use
Surgical Clipper and Charging Adapter Stand
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cz Česky . . . . . . . 171

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#1 #2 #3
#4 #5

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en
Parts Identification (diagram #1):
1. REF 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. Charging 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 eectively 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
dicult-to-clip areas of the body with BD disposable blade REF 4403A. The Clipper eectively 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
O ...................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. Attach 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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Mode of Operation Continuous
BD Disposable Blades
Mode of Operation Single Use
Operating Voltage / Current 3.25V DC / 390mA (max.)
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)
Disposable Blades REF 4406 & REF 4403A:
Minimum of 80 minutes continuous run-
time up to 120 minutes.
Disposable Blade REF 4412A: Minimum of
50 minutes continuous run-time.
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.
Surgical Clipper Specifications:
Waterproofing IPX7 Rating
Battery Type Li-ion 680mAh
Battery Life Minimum 350 Cycles
Surgical Clipper Specifications (continued):
Weight 200-250g ± 10g. (7-8.80 Oz.)
Power Source 100–240 V AC; 50–60 Hz, 30mA
Type of Protection Against
Electric Shock Class II
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
Charging Adapter Specifications:

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Symbol Explanation:
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.
Temperature
limit
-10°C
+60°C
Humidity
limitation
10%
100%
Atmospheric
pressure limitation
106 kPa
50 kPa
Type B
applied part
Use By
On / Off
Alternating current
Direct current
Watertight Equipment
Operating instructions
Follow operating
instructions
Class II
(Double Insulation)
Do not reuse
Authorized representative in
the European Community
Manufacturer
Medical Device
Unique Device Identifier
Catalog Number
Batch Code

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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.
Any serious incident that has occurred in relation to the device
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.
#6

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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.
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.

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 Electromagnetic environment - guidance
RF emissions
CISPR 11 Group 1
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.
RF emissions
CISPR 11 Class B
REF 5513E/5514 series is suitable 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
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