Midwest Rdh freedom Manual

ENGLISH • 1

Directions For Use

Mode d’emploi

Instrucciones de uso

Gebrauchsanweisung

Istruzioni per l’uso

Указания по применению

Le système de prophylaxie sans l

El Sistema de Prolaxis Inalámbrico

Kabellose Prophylaxe-System

Il sistema di prolassi senza li

Беспроводной профилактической системы

Cordless Prophy System

Please read carefully and completely before operating unit.

Prière de lire attentivement et complètement avant la première

utilisation de l’appareil.

Por favor lea cuidadosamente y en su totalidad antes de operar la unidad.

Bitte vor Inbetriebnahme der Einheit sorgfältig und vollständig durchlesen.

Si prega di leggere attentamente e completamente prima di utilizzare

l’apparecchio.

Пожалуйста, внимательно и полностью прочтите перед использованием

устройства.

ENGLISH • 2

TABLE OF CONTENTS

OVERVIEW . . . . . . . . . . . . . . . . . . . . 3

1. INDICATIONS FOR USE. . . . . . . . 3

2. CONTRAINDICATIONS . . . . . . . . 3

3. WARNINGS . . . . . . . . . . . . . . . . 3

4. PRECAUTIONS . . . . . . . . . . . . . . 4

5. ADVERSE REACTIONS . . . . . . . . 4

6. MIDWEST®RDH FREEDOM®

CORDLESS PROPHY SYSTEM

DESCRIPTION . . . . . . . . . . . . . . 5

7. UNPACKING THE SYSTEM . . . . . 6

8. INFECTION CONTROL

PROCEDURES . . . . . . . . . . . . . 6

9. SYSTEM SETUP . . . . . . . . . . . . . 9

10. CHARGING THE HANDPIECE

AND FOOT PEDAL . . . . . . . . . . . 9

11. SYNCHRONIZING THE

HANDPIECE AND FOOT

PEDAL . . . . . . . . . . . . . . . . . . . 10

12. PREPARATION FOR USE. . . . . . 11

13. OPERATION . . . . . . . . . . . . . . . 12

14. HANDPIECE INDICATOR

LIGHTS (WHEN IN USE) . . . . . . 12

15. SPECIFICATIONS . . . . . . . . . . . 13

16. CLASSIFICATIONS . . . . . . . . . . 13

17. SYMBOL IDENTIFICATION. . . . . 14

18. DISPOSAL OF UNIT. . . . . . . . . . 15

19. TROUBLESHOOTING. . . . . . . . . 15

20. ACCESSORIES . . . . . . . . . . . . . 17

21. LIMITED WARRANTY . . . . . . . . 18

ENGLISH • 3

1. Indications for Use

The Midwest RDH Freedom is a high-performance

cordless prophylaxis handpiece with a wireless foot

pedal for use with Nupro Freedom® disposable

prophylaxis angles in a hygiene operatory to perform

cleaning and polishing procedures on teeth.

WARNING Use care to prevent personal and / or patient injury

PRECAUTION Use care to prevent product damage and ensure safe and effective product use

Safety Conventions in This Document

3. Warnings

• To prevent damage, charge the handpiece using

only the Midwest RDH Freedom charging base

and power supply.

• Sterilizing the inner module will cause component

damage to the handpiece and the sterilizing equip-

ment, and may cause personal bodily injury.

• The outer sheath must be steam sterilized before

first use and between patients to prevent cross

contamination. See Section 8 for the Infection

Control Procedures.

• The Disposable Prophy Angles are designed for

single-patient use only and should never be used

more than once. Disposable Prophy Angles are not

autoclavable or designed to withstand disinfection

solutions. The risk of reuse of a Disposable Prophy

Angle are damage to equipment and cross-con-

tamination. Install a new Prophy Angle before each

use.

• It is the responsibility of the Dental Healthcare

Professional to determine the appropriate uses of

this product and to understand:

• the health of each patient

• the dental procedures being undertaken

• applicable industry and governmental agency

recommendations for infection control in dental

healthcare settings

• requirements and regulations for safe practice

of dentistry

• these Directions for Use in their entirety

• Per FCC Part 15.21, changes or modifications not

expressly approved by the party responsible for

compliance could void the user’s authority to oper-

ate this equipment.

• Failure to follow recommendations for environ-

mental operating conditions (see Section 15 for

Specifications) could result in injury to patients or

users.

• Inspect the handpiece system before each use for

worn, loose or damaged parts. Do not attempt to

operate unless the Disposable Prophy Angle (DPA)

is properly installed. A loose DPA could eject from

the handpiece causing bodily injury. Reinstall the

DPA or replace any damaged parts as necessary.

• To prevent bodily injury and damage to the device,

do not sterilize the disposable prophy angle, inner

module, charging base, foot pedal or power supply.

Disinfect the inner module, charging base, foot

pedal and power supply using only the tested and

approved disinfectants listed in Section 8, Infection

Control Procedures.

• Operating the Disposable Prophy Angle at an

excessive speed or with excessive force may

cause heating of the tooth and temporary discom-

fort to the patient.

• The inner module, foot pedal, charging base and

power supply are not waterproof. To prevent dam-

age to the equipment, contamination or bodily

injury, do not immerse any of these components in

water or a chemical solution.

• Use only components and accessories listed in

Section 7 of this manual. Failure to do so will void

the warranty, may decrease system performance

and may lead to unsafe operation.

Overview

The MIDWEST®RDH Freedom®Cordless Prophy System offers a cordless design that eliminates cord drag and

allows clinicians easy access and comfort during prophylaxis procedures. Quieter than traditional hygiene and low

speed handpieces, the system offers all-day battery life while delivering the same performance you would expect

from a corded handpiece. The system includes an autoclavable outer sheath for infection control.

2. Contraindications

None Known.

ENGLISH • 4

• Never mount a Disposable Prophy Angle to the

handpiece body while it is operating.

• Dispose of Nupro Freedom® Disposable Prophy

Angles after each patient according to CDC

Guidlines for Infectious Waste and Federal, State

and Local regulations.

• There are no user-serviceable items in the inner

module, power supply, outer sheath, foot pedal or

charging base. Opening any of these units may

result in unsafe operation and will void the war-

ranty.

• According to IEC 60601-1/UL60601-1, this device

must not be used in the presence of a flammable

anesthetic gas mixed with air, oxygen, or nitrous

oxide. (Note: nitrous oxide by itself is not a flam-

mable anesthetic gas.).

4. Precautions

• Before using this product, carefully read and follow

all instructions and save them for future reference.

Observe all precautions and warnings.

• The handpiece system can only be used with

Nupro Freedom® Disposable Prophy Angles.

• As with all dental procedures, use universal pre-

cautions (i.e., wear face mask, eyewear, or face

shield, gloves and protective gown).

• The inner module motor is designed to be lube-

free. Lubrication may cause damage to the inner

module.

• Oil and/or dirt may damage the motor, electron-

ics and battery located inside the handpiece inner

module.

• The batteries are not user replaceable. When

needed, the units should be returned to the listed

repair center for replacement.

• Do not place the system on or next to a radiator

or other heat source. Excessive heat may damage

the system’s electronics.

•Inadvertent system shutdown may occur in the

presence of strong non-compliant radio frequency-

generating components.

• This device complies with part 15 of the FCC

Rules and with Industry Canada license-exempt

RSS standard(s). Operation is subject to the fol-

lowing two conditions: (1) This device may not

cause harmful interference, and (2) This device

must accept any interference received, including

interference that may cause undesired operation.

Changes or modifications not expressly approved

by the party responsible for compliance (i.e. the

manufacturer) could void the user’s authority to

operate the equipment.

This Class B digital apparatus complies with

Canadian ICES-003.

• Under Industry Canada regulations, this radio

transmitter may only operate using an antenna of

a type and maximum (or lesser) gain approved

for the transmitter by Industry Canada. To reduce

potential radio interference to other users, the

antenna type and its gain should be so chosen that

the equivalent isotropically radiated power (e.i.r.p.)

is not more than that necessary for successful

communication.

• This equipment has been tested and found to

comply with the limits for a Class B digital device,

pursuant to Part 15 of the FCC Rules. These lim-

its are designed to provide reasonable protection

against harmful interference in a residential instal-

lation. 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 radio communica-

tions. However, there is no guarantee that interfer-

ence will not occur in a particular installation. If

this equipment does cause harmful interference to

radio or television reception, which can be deter-

mined by turning the equipment off and on, the

user is encouraged to try to correct the interfer-

ence by one or more of the following measures:

• Reorient or relocate the receiving antenna.

• Increase the separation between the equip-

ment and receiver.

• Connect the equipment into an outlet on a

circuit different from that to which the receiver

is connected.

5. Adverse Reactions

There are no known adverse reactions.

ENGLISH • 5

6. MIDWEST®RDH Freedom® Cordless Prophy System Description

Nupro Freedom®

Disposable Prophy Angle

Removable, Autoclavable

Outer Sheath

Charging Base

(See Section 10)

Removable, Replaceable

Color Ring

Inner

Module

LED Indicator Lights

(Charging - See Section 10)

(Operation - See Section 14)

Wireless Rechargable Foot Pedal

(Charging - See Section 10)

(Syncronization - See Section 10)

Handpiece Tray

Cradle - Autoclavable

Handpiece Tray

Cradle - Autoclavable

Module

LED Indicator Lights

(Charging - See Section 10)

ENGLISH • 6

7. Unpacking the System

As you unpack your MIDWEST®RDH Freedom® Cordless Prophy System, verify that the following compo-

nents and accessories are included:

8. Infection Control Procedures

The objective of the information provided in this section is to reduce the potential for cross contamination when

using a MIDWEST®RDH Freedom® Cordless Prophy System during routine dental care. In the event any

regulatory agency disagrees with this information, the agency requirements take precedence.

NOTE: Outer sheaths and handpiece cradle must be steam-autoclave sterilized prior to each use.

Additional outer sheaths and handpiece cradles are available for purchase.

Basic System:

1- Handpiece Inner Module

1- Handpiece Outer Sheath

1- Charging Base

1- Wireless Foot Pedal

1- Power Supply

1- Double-ended extension cable (not shown)

20- NUPRO Freedom Disposable Prophy

Angles (DPAs)

1- Disposa-Shield Trial Pack (25)

1- Handpiece Cradle

Premium System:

1- Handpiece Inner Module

3- Handpiece Outer Sheaths

1- Charging Base

1- Wireless Foot Pedal

1- Power Supply

1- Double-ended extension cable (not shown)

20- NUPRO Freedom Disposable Prophy

Angles (DPAs)

1- Disposa-Shield Trial Pack (25)

1- Handpiece Cradle

1- Carrying case

ENGLISH • 7

WARNINGS These instructions are for use ONLY on the outer sheath and handpiece cradle. All

other parts of the system should be disinfected according to the procedures in the

“Disinfection” section.

The outer sheath and handpiece cradle for the MIDWEST®RDH Freedom® Cordless

Prophy System are not sterile upon receipt and must be sterilized prior to use in

accordance with the following instructions.

LIMITATIONS ON

REPROCESSING The Handpiece Cradle may only be sterilized following the pre-vacuum sterilization

procedures. The Gravity Steam sterilization procedures have not been validated for the

Handpiece Cradle.

Do not use an automatic washer/disinfector for the sheath. Discoloration of material

will occur.

Repeated cleaning and sterilization cycles have minimum effect on these instruments.

End of life is normally determined by wear and damage due to use.

Do not use chemical disinfectants prior to sterilization or rapid deterioration of the

material may occur.

Cold liquid disinfection/sterilization, chemical vapor sterilization, and dry heat

sterilization methods have not been tested or validated for efficacy and are not

recommended for use.

Do not immerse the outer sheath or handpiece cradle in an ultrasonic bath.

POINT OF USE Remove excess soil with disposable cloth or paper wipe.

It is recommended that instruments are reprocessed as soon as is reasonably practical

following use.

CONTAINMENT AND

TRANSPORTATION Protect the outer sheath and handpiece cradle from contact with other dental

instruments that may cause damage.

PREPARATION FOR

DECONTAMINATION Remove the outer sheath from the inner module of the handpiece. Only the outer

sheath, color ring of the handpiece, and handpiece cradle may be steam-autoclave

sterilized.

CLEANING: MANUAL Rinse the instruments with running water to remove any gross debris.

DISINFECTION Disinfection of the instruments is not necessary prior to steam - autoclave sterilization.

PACKAGING Place each instrument in a separate paper or paper/plastic steam-sterilization pouch.

If using a sterilizing cassette, ensure that the sterilizer’s maximum load is not exceeded.

STERILIZATION Use a steam autoclave. Place bagged instruments into the steam autoclave, paper

side up when using a paper/plastic pouch.

Gravity Steam Sterilization

Full Cycle:135°C (275°F) for 3.5 minutes

Pre-vacuum Steam Sterilization

Full Cycle:132°C (270°F) for 3 minutes

Alternate Method: Place non-bagged instruments into the steam autoclave and run at

the listed cycles.

NOTE: Instruments sterilized unbagged should be used immediately.

DRYING To dry, use the drying cycle of the autoclave. Set cycle for 20 to 30 minutes. Do not

exceed 137°C.

Instructions for Sterilizing The Outer Sheath And Handpiece Cradle

The Handpiece Cradle may only be sterilized following the pre-vacuum

sterilization procedures. The Gravity Steam sterilization procedures have

not been validated for the Handpiece Cradle.

ENGLISH • 8

WARNINGS The charging base, inner module, foot pedal, power supply and double-ended

extension cable (not shown) are not sterilizable by autoclave, but can be disinfected

following the procedures listed below.

Only use water based non-immersion type disinfectant solutions.

Per the Centers for Disease Control and Prevention (CDC), chemical germicide

registered with the EPA as a “hospital disinfectant” and labeled for “tuberculocidal”

(i.e., mycobactericidal) activity is recommended for disinfecting surfaces that have

been soiled with patient material. These intermediate-level disinfectants include

phenolics, and chlorine-containing compounds.

The following tuberculocidal disinfectants are safe for use on the components listed

above: • Phenolics (Dual Water-Based) such as Birex SE Concentrate or Disinfectant

Wipes (Manufactured by Biotrol)

• Phenolics (Dual Alcohol-Based) such as Cavicide Spray or Wipes

(Manufactured by TotalCare)

• Quarternaries (Dual or Synergized Plus Alcohol) such as Lysol IC

Disinfectant Spray (Manufactured by Sultan Heathcare)

• Sodium Hypochlorite such as Clorox Germicidal Spray or Wipes

(Manufactured by Harry J. Bosworth Company)

• Sodium Bromide & Chlorine (Microstat Tablets) 2 tablets/quart of water

LIMITATIONS ON

REPROCESSING Repeated cleaning has minimum effect on these instruments. End of life is normally

determined by wear and damage due to use.

Do not use disinfectant solution on sterilizable outer sheaths. Refer to sterilization

procedures for sterilizable outer sheaths.

POINT OF USE Remove excess soil with disposable cloth or paper wipe. Discard wipe after use.

CONTAINMENT AND

TRANSPORTATION Handle with care.

CLEANING Generously spray disinfectant solution on a clean cloth. Wipe the outer surfaces of

the charging base, inner module, foot pedal, power supply and cords. Discard used

cloth. Wipe dry with a clean cloth.

DISINFECTION Generously spray disinfectant solution on a clean cloth. Wipe the outer surfaces of the

charging base, inner module, foot pedal, and the power supply and its cord.

Discard used cloth.

Allow disinfectant to air dry.

Instructions For Disinfecting All Other Parts (Charging Base, Inner Module, Foot Pedal and Power Supply)

MAINTENANCE Visually inspect to ensure that all contamination has been removed.

Check for distortion, damage or wear. Discard damaged, worn or corroded

instruments.

STORAGE To maintain sterility, instruments should remain bagged until ready for use.

MANUFACTURER CONTACT In the United States, contact DENTSPLY Professional Customer Service Technical

Support at 800-989-8826. For areas outside the United States, contact your local

DENTSPLY Division.

Instructions For Sterilizing The Outer Sheath And Tray Cradle, Cont.

Only use water based non-immersion type disinfectant solutions.

Per the Centers for Disease Control and Prevention (CDC), chemical germicide

registered with the EPA as a “hospital disinfectant” and labeled for “tuberculocidal”

ENGLISH • 9

DRYING When cleaning, wipe surfaces dry with a clean cloth. To achieve disinfection, allow

surfaces to air dry.

MAINTENANCE Visually inspect to ensure that all contamination has been removed.

Visually inspect power supply and cords for damage.

STORAGE Ambient temperature range: -20˚C to 50˚C

Relative humidity range: 45 - 95% (non-condensing)

MANUFACTURER CONTACT In the United States, contact DENTSPLY Professional Customer Service Technical

Support at 800-989-8826. For areas outside the United States, contact your local

DENTSPLY Division.

Instructions For Disinfecting All Other Parts (Charging Base, Inner Module, Foot Pedal and Power Supply), Cont.

The instructions provided above have been validated by DENTSPLY as being capable of preparing a medical device for

re-use. It remains the responsibility of the processor to ensure that the processing is actually performed using equipment,

materials and personnel in the processing facility to achieve the desired result. This requires validation and routine

monitoring of the process. Likewise, any deviation by the processor from the instructions provided should be properly

evaluated for effectiveness and potential adverse consequences.

9. System Setup

Both the handpiece and foot pedal must be

charged prior to first use. Only use the Midwest

RDH Freedom power supply. Failure to do so

could cause your system to malfunction and

void your warranty. Charge the handpiece and

foot pedal for at least 90 minutes. (See Section 10,

Charging the Handpiece and Foot Pedal).

10. Charging the Handpiece and Foot

Pedal

When the corresponding indicator light is orange,

the handpiece and/or foot pedal must be charged.

10.1 A double-ended extension cable has been sup-

plied that allows you to charge both the inner

module and the foot pedal at the same time. Plug

the female onto the Power Supply Cable plug and

plug the male ends into the charging base and foot

pedal.

You can also charge the inner module and the foot

pedal individually using the power supply cable

alone.

10.2 Plug the power supply into a wall outlet.

NOTE: The green power-on indicator on the back of the

charging base illuminates when the charging base is

successfully connected.

NOTE: Unplug the power supply from the wall outlet

(power mains) to remove all power to the charging base.

PRECAUTION: Connect to single phase AC power 100-

240V power only. Otherwise, malfunction will occur.

Do not unplug the power supply by pulling on the cord.

Handpiece charge

indicator

Foot-pedal charge

indicator

Power supply

connector

Power supply

connector

Power Indicator

ENGLISH • 10

10.3 Place the inner module or handpiece on the

charging base, aligning the charging contacts on

each.

10.4 Refer to the figure and table below to determine

the charging progress for the inner module.

NOTE:

• The handpiece should be recharged after each full day’s

use.

• If necessary, the handpiece may be “quick charged” for

a single use in 15 minutes.

10.5 The foot pedal should be recharged monthly. A

fully discharged foot pedal will need approximately

90 minutes to fully recharge. The foot pedal may

be operated while charging.

NOTE:

• The middle LED light on the inner module denotes the

degree of the charge in the foot pedal battery. A solid

green light means greater than 30%. A solid orange

light means less than 30%.

Indicator Lights Degree of Charge

Scrolling orange Less than 50%

Scrolling green 50-90%

Solid green Greater than 95%

NOTE:

• After one week of non-use, both the handpiece and the

foot pedal enter an enhanced battery-saving mode.

• Place the handpiece inner module into an

energized charging base for 5 seconds to

restore normal functions.

• Connect the foot pedal to the power supply for 5

seconds to restore normal functions.

11. Synchronizing the Handpiece and

Foot Pedal

NOTE:

Follow this procedure when:

• the foot pedal or handpiece inner module is replaced

for any reason

• the handpiece and foot pedal do not seem to be

communicating properly

11.1 Place the foot pedal within 10 feet of the charging

base.

11.2 Invert the foot pedal and remove the screw and the

access door.

11.3 Remove the inner module from the outer sheath of

the handpiece.

11.4 Place the inner module on the charging base,

ensuring that the three indicator lights are scrolling

or all are solid green.

Charging Contacts

Indicator lights

Screw

Access Door

ENGLISH • 11

12. Preparation for Use

12.1 Position the foot pedal for use, ensuring that the

floor is level.

12.2 Ensure that the outer sheath has been sterilized

according to the Infection Control Procedures (sec-

tion 8).

12.3 When it is sufficiently charged, insert the inner

module into a Disposa-Shield®sleeve. Ensure that

the nose of the inner module completely clears the

opening of the Disposa-Shield sleeve.

PRECAUTION: Do not install the covered inner module

into the outer sheath without ensuring the Disposa-

Shield sleeve is clear of the inner module nose. The

Disposa-Shield protects the inner module from debris

and splatter. Do NOT apply the Disposa-Shield to the

outer sheath, which must be sterilized before each use.

12.4 Install the inner module into the outer sheath by

aligning the swoops on each and snapping in

place.

12.5 Attach a NUPRO Freedom Disposable Prophy

Angle to the handpiece by aligning the swoops on

each and snapping in place.

12.6 Verify that all parts of the handpiece are securely

attached before use.

Aligned correctly

Fully-Assembled Handpiece

11.5 Invert the inner module and place it on the charg-

ing base as shown. The LED shown below will

blink green if the position is correct for synchroni-

zation.

11.6 When the indicator lights display a scrolling green

and orange pattern, press the red button in the

bottom compartment of the foot pedal within 15

seconds.

NOTE:

• The LED beside the synchronization switch of the foot

pedal flashes orange to indicate that the foot pedal is in

synchronization mode.

11.7 If the synchronization was successful, the three

indicator lights on the handpiece and the LED in

the foot pedal will flash green several times.

11.8 If all three handpiece indicator lights, and the foot

pedal LED flash orange, the syncing was unsuc-

cessful. Return the inner module to an upright

position in the charging base and repeat the proce-

dure.

Access Door

LED

place.

Aligned correctly

ENGLISH • 12

13. Operation

13.1 The handpiece powers up when it detects motion, i.e. when the user picks it up. If not in use, it will shut

down again after a minute.

13.2 Load the DPA with prophy paste and depress the foot pedal slowly to avoid splatter. The DPA (motor) will

only rotate in one direction.

13.3 Adjust pressure on the foot pedal to control the rotation speed of the DPA throughout the procedure.

13.4 Follow standard prophylaxis procedures as you would with any corded prophy device.

13.5 You only need to apply a light pressure during polishings. Applying excessive force to the polishing surface

may slow or stop the rotation of the DPA and result in ineffective polishing.

13.6 The Handpiece Cradle should be placed on the instrument tray so that the Handpiece may be placed in it to

avoid the handpiece possibly rolling and falling off the tray during a prophylaxis procedure.

NOTES:

• If the handpiece seems to be losing power, recharge as

soon as possible.

• If the handpiece battery is completely discharged, the

three LEDs will blink and the unit will shut down. The

handpiece must be put in the charging base before it’s

able to operate again.

14. Handpiece Indicator Lights (when in use)

The MIDWEST®RDH Freedom® Cordless Prophy System handpiece has three LEDs. Whenever the handpiece

is in normal operational mode (i.e., not being charged or synchronized) the handpiece indicator lights display

information about the system according to the table below:

Handpiece charge

indicator

Temperature

indicator light

Foot-pedal charge

indicator

Degree of Charge Color Light Functional Description

Handpiece charge

indicator Orange Handpiece charge less than 50%

Green Handpiece charge greater than 50%

Foot-pedal charge indicator Orange Foot pedal charge less than 30%

Green Foot pedal charge greater than 30%

Temperature indicator light Orange Illuminates when the internal temperature of the handpiece is higher than

normal. The light will turn off when the temperature returns to normal.

Operator should refrain from using the handpiece for several minutes until

the indicator light goes out. If the temperature indicator light persists, call

technical support.

ENGLISH • 13

15. Specifications

16. Classifications

Power Supply manufacturer:

Power Supply model number:

AC Input

Ault (SL Power)

MW170KB0502B03

Continuous (100-240 VAC)

AC Input Current Less than 0.7A

AC Input Phases Single

AC Input Frequency 50-60 Hz

DC Output Power 8W

DC Output Voltage and Current +5VDC at 1.6A

Output Regulation +/- 10%

Weight Handpiece with metal sheath = 120 g

Foot pedal = 200 g

Dimensions Handpiece with sheath & disposable angle

L = 190 mm, W = 30 mm

Foot pedal W = 118 mm H = 40 mm

Foot Pedal Protection Class IPX1. Not for operating theatres.

Remote Communication Frequency:

Power:

Channels:

2405-2480 MHz

1mW

Operating Environment Ambient temperature:

Relative Humidity:

Atmospheric Pressure:

Altitude:

10°C-40°C

45-95% (non-condensing)

80-106 kPa

< 2,000 meters

Transport and Storage Conditions Ambient temperature:

Relative Humidity:

Atmospheric Pressure:

Altitude:

-20°C to 50°C

45-95% (non-condensing)

54-106 kPa

< 5,000 meters

Handpiece Performance Protection Class IPX3.

Max Cup Speed

Max Torque 3000 rpm

10 mNm

Type of protection against electric shock: Class II

Degree of protection against electric shock: Type B Applied Part

Mode of operation for handpiece:

Mode of operation for foot pedal:

Non-continuous: 5 minutes ON, 25 minutes OFF

Continuous

Degree of safety of application in the presence of a

flammable anesthetic mixture with air or with oxygen or

nitrous oxide:

Equipment not suitable for use in the presence of flammable

mixtures

According to medical device directive: IIA (Rule 9) (ISO/IEC 60601)

Pollution Degree Classification Pollution Degree 2

Overvoltage Category Category II (connected to wall outlet)

ENGLISH • 14

17. Symbol Identification

The following standard symbols appear on the device label.

Class II

Equipment

Class II Equipment

Type B applied part

MEDICAL EQUIPMENT

WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN

ACCORDANCE WITH UL-2601-1/60601-1, CAN/CSA C22.2 NO.601.1

Consult instructions for use

135 Sterilizable up to the temperature specified

Do not re-use

Do not re-use (For DPAs)

Dispose of in accordance with the Waste Electrical and Electronic Equipment Directive 2002/96/

EC of the European Parliament and the Council of the European Union

IPX0 Protection Class IPX0

IPX0 Classification of ingress of water for Charger – not protected

IPX1 Footswitch not for operating theatres

Protection Class IPX1

IPX1 Classification of ingress of water

IPX3 Protection Class IPX3

IPX3 Classification of ingress of water for Inner Module - Protected against falling spray.

5 min

25 min

Duty Cycle for handpiece:

5 minutes ON

25 minutes OFF

Serial Number

LOT Batch Code/Lot Number

This symbol is a mandatory marking for devices entering the European market to indicate conformity

with the essential health and safety requirements set out in European Directives. The symbol may be

accompanied by a four-digit identification number of the notified body.

5V-1A Direct Current (DC) supply. 5 Volts, 1 Amp

Polarity of power (DC). Positive counter.

Do Not Autoclave (Inner Module)

ENGLISH • 15

18.Disposal of Unit

U.S. - Dispose of the system components in accordance with state and local laws.

EU - Dispose of in accordance with the Waste Electrical and Electronic Equipment Directive 2002/96/EC of the

European Parliment and the Council of the European Union.

19. Troubleshooting

Problem Solution

DPA is not revolving. 1. Ensure the outer sheath and the DPA are snapped

together securely.

2. Ensure that the Inner Module and the Outer Sheath are

snapped together securely.

3. Verify the handpiece is powered up and properly

charged. If the handpiece lights do not illuminate,

place the handpiece in the charging base for a

minimum of 5 seconds, and then remove it to use.

4. Verify the foot pedal is not in battery saving mode or

discharged. This is done by connecting the power

supply to the foot pedal. The foot pedal will operate

while charging.

5. Ensure the DPA is not damaged by removing the DPA

and spinning the cup between your fingers. The cup

should spin freely.

6. Ensure that the sheath is not damaged by removing

the inner module from the sheath, leaving the DPA

connected, and spinning the DPA cup between your

fingers. The cup should spin freely. If the cup does not

spin freely, place 1-2 drops of MIDWEST Lubricant into

the sheath nose and try to spin again. If the cup still

does not spin freely, call Technical Support.

7. If DPA still does not spin freely, remove the sheath

from the inner module and verify the inner module

motor spins when the foot pedal is depressed. If the

inner module motor does not spin, resynchronize the

foot pedal with the inner module as per instructions

contained in this manual.

8. Resynchronize the units. See Section 11 Synchronizing

the Handpiece and Foot Pedal.

9. If the synchronization is not successful and/or the

handpiece still does not spin, call Technical Support.

Excessive noise or vibration during operation. 1. Ensure that the outer sheath is aligned correctly with the

inner module.

2. Check the components for gross debris or

contamination and adhere to all infection control

procedures.

3. Check for damaged, worn or broken components.

4. Call Technical Support if necessary.

Foot pedal does not charge. 1. Ensure that the power cord is securely attached to the

wall outlet and the foot pedal.

2. Remove the foot pedal access door and look in

the compartment; ensure that the LED in the bottom

compartment is illuminated. If not, return the foot

pedal to Technical Support for professional battery

replacement.

ENGLISH • 16

Difficulty removing outer sheath from inner module. 1. Check the components for gross debris

2. Hold the handpiece outer sheath securely and twist the

inner module

3. Inspect parts for wear

4. Call Technical Support if necessary

Charging base does not drain liquids. Clear any debris from the hole at the bottom of the

charging base.

Handpiece does not charge. 1. Clean the charge contacts on the handpiece and

charging base, using one of the approved cleaning

solutions described in section 8.

2. Verify that the power supply is properly connected to

the charging base and that the green LED on back

lights up.

3. Verify that the handpiece is able to properly sit inside

the charging base, and that there are no foreign

obstructions.

4. If still not charging, return the handpiece to Technical

Support for professional battery replacement.

Handpiece does not hold charge. 1. Verify that the handpiece properly charges (LEDs scroll

when in the charger).

2. Return the handpiece to Technical Support for

professional battery replacement.

Orange Service Light in handpiece illuminates. 1. Handpiece is heating up due to excess ON time or

load. Do not use handpiece for several minutes and

allow it to cool down.

2. If LED still illuminates even after allowing handpiece to

cool down, set aside and call Technical Support.

Power supply overheating. Immediately unplug the unit and call Technical Support.

Power cords are frayed or damaged in any way. Do not use. Call Technical Support.

NOTE:

For current Technical Support contact information, see “Manufacturer contact“ in the infection control procedures

(section 8).

ENGLISH • 17

20. Accessories

MIDWEST RDH FREEDOM

Item Description DENTSPLY Part Number

Outer Sheath 9070301

Inner Module, Lavender 9070402

Inner Module, Pink 9070404

Charging Base, Lavender 9070502

Charging Base, Pink 9070504

Wireless Foot Pedal 9070601

Power Supply-Domestic 9070701

Double-ended Extension Cable 90730

Power Supply, with Adapter Plugs - International 9070702

Handpiece Cradle 9070801

Carrying Case 9070901

Color Rings, Sheath-Multi Colored Package 9071001

Disposa-Shield Surface Barrier A88018D5

Item Description DENTSPLY Part Number

NUPRO Freedom DPA, Lavender Soft Cup – Box/100 96570001

NUPRO Freedom DPA, Lavender Firm Cup – Box/100 96570101

NUPRO Freedom DPA, Lavender Brush Cup – Box/100 96570201

NUPRO Freedom DPA, Pink Soft Cup – Box/100 96570601

NUPRO Freedom DPA, Pink Firm Cup – Box/100 96570701

Item Description DENTSPLY Part Number

NUPRO Freedom Prophy Pack – Box/100

• NUPRO Prophy Paste Mint Flavor, Medium Grit