Midmark Elevance® Standard Delivery System Mode d'emploi

User GuideUser Guide

Assistant’s Unit

Integration

Control

Module

®

Indications for Use, Calling Service etc. .....2

Symbols ......................................................3

Standard Water Bottler System .................4

Optional Water Selector Switch System .....4

Master Switch and USB Port ......................5

Work Surface Weight Limit ........................5

Manual Shut-Os - Water & Air Supply ......6

Pressure Regulator Valves ........................6

Flex Arm (Brake) .......................................7

Quick-Connects/ HVE/Saliva Ejectors ........8

Link to Software Specic ICM Screens

Operating Handpieces ...............................9

Syringe Adjustment Knobs .......................10

Coolant Air Control Knob ..........................10

Bypass Toggles .......................................10

Syringe Operation.....................................11

Adjustment Knobs - Assistant’s Unit ......... 11

Barriers .....................................................12

Cleaning, Disinfecting and Maintenance ..12

Handpiece Accessories ............................12

General Cleaning / Visual Inspection .......12

Waterline Maintenance .............................12

Cleaning & Disinfecting Assistance ..........12

Beginning of Each Day... ..........................13

Flushing System- Between Patients .........14

Flushing System- End of Day ...................15

Air/Oil Separator - Clean / Maintain ..........16

Maintain / Replace Regulator Filters ........16

Specs / Replacement Parts .....................17

EMC - Manufacturer’s Declaration and

Guidance ..................................................18

Warranty Information ................................21

Technical Library at Midmark.com

Indications for Use, Calling Service etc. .....2

Symbols ......................................................3

Standard Water Bottler System .................4

Optional Water Selector Switch System .....4

Master Switch and USB Port ......................5

Work Surface Weight Limit ........................5

Manual Shut-Os - Water & Air Supply ......6

Pressure Regulator Valves ........................6

Flex Arm (Brake) .......................................7

Quick-Connects/ HVE/Saliva Ejectors ........8

Link to Software Specic ICM Screens

Operating Handpieces ...............................9

Syringe Adjustment Knobs .......................10

Coolant Air Control Knob ..........................10

Bypass Toggles .......................................10

Syringe Operation.....................................11

Adjustment Knobs - Assistant’s Unit ......... 11

Barriers .....................................................12

Cleaning, Disinfecting and Maintenance ..12

Handpiece Accessories ............................12

General Cleaning / Visual Inspection .......12

Waterline Maintenance .............................12

Cleaning & Disinfecting Assistance ..........12

Beginning of Each Day... ..........................13

Flushing System- Between Patients .........14

Flushing System- End of Day ...................15

Air/Oil Separator - Clean / Maintain ..........16

Maintain / Replace Regulator Filters ........16

Specs / Replacement Parts .....................17

EMC - Manufacturer’s Declaration and

Guidance ..................................................18

Warranty Information ................................21

Technical Library at Midmark.com

Serial Number

Location

Delivery Unit

English

Español

Français

Style P

TP200 20-42-FO-00012 Rev A1 C2169

003-2301-99 Rev MA7 (5/1/19)

Elevance

®

Standard

Delivery System

[Includes: Delivery Unit and Assistant’s Unit]

midmark.com

Indications for Use

Midmark instrument delivery systems are intended to provide dental

professionals with air, water, and suction along with low-voltage electricity

to operate dental handpieces, syringes, and accessories during dental

examinations and treatments.

Disposal of Equipment

At the end of this product’s life, the unit, accessories and other consumable

goods may be contaminated from normal use. Consult local codes and

ordinances for proper disposal of this equipment and other consumable goods.

Transportation / Storage / Operating Conditions

Transportation / Storage Temperature: ...........23°F to 100°F (-5°C to 38°C)

Relative Humidity:........................................ 10% to 90% (non-condensing)

Atmospheric Pressure: ................. 7.2 PSI to 15.3 PSI (50 kPa to 106 kPa)

Operating Temperature Range: ......................59°F to 95°F (15°C to 35°C)

Electromagnetic Interference

Midmark dental operatory components are designed and built to minimize

electromagnetic interference with other devices. However, if interference is

noticed between another device and this operatory, remove the interfering

device from room and / or plug product into an isolated circuit.

Compliance Information and Symbols

Calling For Service

Direct all service inquiries to your authorized Midmark dealer. When

calling for service, you must provide the following information:

Model / serial number

Date of purchase

Symptom(s) of malfunction

Caution

Federal law restricts this device to sale by or on

the order of a licensed dental practitioner.

WARNING

Do not modify this equipment without authorization

of the manufacturer.

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Equipment Alert

Indicates a potentially hazardous situation which

could result in equipment damage if not avoided.

Caution

Indicates a potentially hazardous situation which may

result in minor or moderate injury if not avoided. It may

also be used to alert against unsafe practices

WARNING

Indicates a potentially hazardous situation which

could result in serious injury if not avoided.

Humidity

Limit

Type BF,

Applied Part

Type B,

Applied Part

Proper Shipping

Orientation

Fragile

Protective

Earth Ground

Pressure

Limit

Temperature

Limit

100 F

38 C

23 F

-5 C

Maximum stacking

height (Refer to “n”

number on package.)

Keep Dry

Note

Amplifies a procedure, practice, or condition.

USB

Refer to instruction

manual/booklet

Symbols

These symbols may appear on your equipment and/or in the manuals.

Warnings and cautions are provided in the manuals where applicable.

Manufacturer

Catalogue Number

Serial Number

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To fill the Water Bottle...

A) Verify system is depressurized.

B) Unscrew water bottle from the quick disconnect mounting cap.

C) Fill bottle with water.

D) Screw water bottle into quick disconnect mounting cap.

Note: You will hear a hissing noise when air is supplied to the system if the bottle is

improperly installed.

Before filling bottle on a water selector switch system...

A) Turn master switch OFF.

B) Press and hold syringe air button until all residual air pressure

is released (you can hear it stop hissing).

Standard Water Bottle System

The standard bottle water system features an air supply switch to shut o air

supplied to the bottle system.

Optional Water Selector Switch System

The optional water selector switch system uses a toggle switch to select either

city or bottle water. Before removing the water bottle from this

system, turn the master switch OFF and hold down the syringe air button to

release residual air in the system.

Equipment Alert

The Air Supply Switch and the Water Selector Switch are mounted in

the same location. Operation of the switch depends on which type of

water system your delivery has.

LR

Quick

Disconnect

Mounting

Cap

ON

OFF

ON

OFF

CONSOLE

Air Supply

Switch

Water

Selector

Switch

Air Supply

Switch

Water

Selector

Switch

Note

Use water with a hardness level <60 ppm of calcium carbonate.

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English - 4

Product Features

Work Surface Weight Limit

Maximum load on ex arm mounted

units is 10 lb (4.5 kg)

Master Switch and USB Port

The master switch must be ON to operate the delivery system.

To turn the delivery system ON or OFF...

Move the master switch to the desired position.

NOTE

Turning the system OFF may affect recorded data

(e.g. pictures recorded using a camera). Be sure to

retain any needed data before turning system OFF.

Caution

Exceeding the work surface weight limit

may result in personal injury or damage

the equipment.

WARNING

Risk of Electrical Shock Hazard:

Accessory equipment connected to the USB port

must be certified according to IEC 60601-1 safety standards

for electromedical equipment.

ON

OFF

USB Port

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English - 5

DA3027i

0

4

80

100

5

6

7

40

60

80

100

20

0

1

2

3

5

6

7

4

0

Manual Shut-O Valves for Water and Air Supply

Use manual shut-o valves to stop the facility supplied air and water.

Pressure Regulator Valves

Use pressure regulator valves to control the air and water pressure

supplied to delivery instruments.

Recommended Settings:

City Water Regulator

Gauge Setting

30 psi

Air Pressure Regulator

Gauge Setting

80 psi

Equipment Alert

Delivery components were designed

to operate at the recommended settings.

Poor performance or damage to equipment may

result if recommended settings are not maintained.

Pressure regulator adjustment...

A) Pull up knob and turn to adjust.

B) Watch regulator gauge as you turn knob to achieve

desired setting

C) Push knob DOWN to lock.

Air Regulator

Gauge

Air Manual

Shut-o Valve

Water Manual

Shut-o Valve

Optional

City Water

Gauge

Shut-o Valves

Rotate clockwise 1/4

turn to Shut o.

Turn Clockwise

for more pressure

Optional

City Water

Regulator

Adjustment

Knob

Air

Regulator

Adjustment

Knob

Turn Counter-Clockwise

for less pressure

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Flex Arm (Brake)

The ex arm contains a brake mechanism that prevents the unit from lowering until you release it by touching and holding a brake release touch sensor.

To position Elevance delivery unit...

A) Press and hold any brake release touch sensor.

B) Move to desired position.

Brake Release

Touch Sensors

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English - 7

Quick-Connect Ports

Quick-Connect Ports (air [yellow] and water [blue]) allow you to quickly

connect accessories to the delivery system.

Each Quick-Connect Port features a hinged clip that secures the

connecting line to a raised ring found on each port opening.

Water

Air

Water

Air

Console

Upper Pivot

Cover

HVE and Saliva Ejectors

DA2308i

HVE

Open

Closed

Open

Closed

Saliva Ejector

To use HVE and Saliva Ejectors...

A) Verify that facility vacuum system is ON.

B) Move lever to towards the OPEN position to activate

and moderate suction for the HVE / Saliva Ejector.

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Water

Selector

Switch

Illuminates when

Water Button is ON

Handpiece

Handpiece Operation.

A) Turn master switch ON.

B) Move water selector switch to desired setting.

C) Pull handpiece from holder.

D) Press footpedal to deliver drive air / water to

the handpiece.

Operation and Adjustments

Operating Handpieces

Handpieces deliver air and water (if water selector switch is ON) when the footpedal is pressed. The water selector switch on the foot control toggles the water

selection ON or OFF.

Water can also be turned ON or OFF using a water button, located on the delivery unit and on the assistant’s unit control pad. This water button overrides the

water selector switch on the foot control. The most convenient setting is to have the foot control selector switch in the water OFF position and then use one of the

water buttons on the control pads to turn the water OFF and ON. The assistant’s unit has a blue dot that illuminates when the water is ON. The bottom bar of the

display screen informs: Water: On or Water: Normal (meaning the water override is OFF and the selector switch is the active control).

Water Button

Master

Switch

Water

ON

Water Button

Footpedal

Water

OFF

Note

Water control is also impacted by the control

software. Always read the display screens and

indicators to be aware of the active water setting.

Blue

Dot

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Coolant Air

Bypass

Drive Air

Adjustment

Syringe Air

Syringe Water

Bypass

Coolant Water

Adjustment

Water Bypass

Toggle

Drive Air

Bypass Toggle

Syringe Adjustment Knobs

Water and Air is manually controlled by the buttons on the syringe. The volume of water and air supplied to those buttons is manually controlled by the syringe air

and syringe water knobs shown here.

Adjust the Syringe Air and Water

Rotate syringe knobs to modify the volume of air and

water supplied to the syringe. Operation of the syringe is

manual. See Syringe Operation.

Adjust the Coolant Air

Rotate the coolant air knob until the desired coolant air flow

to the handpieces is achieved.

Adjust the Bypass Coolant Water

Rotate the coolant water adjustment knob until the desired

coolant water flow to the handpieces is achieved.

Note: When water toggle in BYPASS position adjustment knob adjusts

coolant water for all handpieces.

Adjust the Bypass Drive Air

Rotate the drive air adjustment knob until the desired drive air

flow to the handpieces is achieved.

Note: When drive air toggle in BYPASS position, the adjustment knob adjusts

drive air for all handpieces.

Bypass Toggles for Handpiece Air and Water

Bypass controls provide a method to manually supply air and water to all the

air-driven handpieces if the ICM loses power. Manual control is available when

the water and drive air bypass toggles are ipped into the BYPASS positions.

Coolant Air Control Knob

The Coolant Air control knob controls the volume of coolant air supplied

to all handpieces.

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TP200 20-42-FO-00012 Rev A1 C2169

English - 10

Press Water Button

for a Water Stream

Press Air Button for

an Air Stream

Press Air and Water

Buttons for a

Water/Air Mist Spray

Syringe Water

Adjustment

Knob

Syringe Air

Adjustment

Knob

Syringe Operation

This page shows operation and adjustment for a standard three-way

syringe.

Before beginning...

Turn the master switch ON.

To adjust the air spray pressure and water spray

pattern...

Rotate the syringe air adjustment knob as desired.

To adjust the water stream pressure and water

spray pattern...

Rotate the syringe water adjustment knob as desired.

Adjustment Knobs - Assistant’s Units

Elevance assistant’s units have screw-type control knobs under the

assistant’s head to adjust air and water ow to the syringe.

Syringe

Water

Syringe

Air

Control

Knobs

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Barriers

Midmark recommends the use of disposable barriers on all clinician controls

that may be in contact with clinician hands and ngers during dental

procedures. The use of barriers signicantly reduces the need for chemical

cleaners, thus prolonging the life of the equipment.

Only use barrier material that is intended for use with dental equipment.

Midmark recommends the use of an FDA market-cleared barrier such as

Pinnacle Cover-all™. Follow barrier manufacturer instructions for proper use

of these products.

Cleaning and Disinfecting

In addition to the use of barriers Midmark recommends the use of an EPA

registered and FDA market-cleared cleaner/disinfectant such as Cavicide™

to be used on all clinician controls or surfaces that may come in contact with

dental instruments during dental procedures.

Follow cleaner/disinfectant manufacturer

instructions for proper use of the product.

Care should be taken to avoid excessive

application and pooling of liquids.

Handpiece Accessories

Only use dental handpiece accessories with the delivery system that are FDA

market-cleared and refer to manufacturer’s instructions for proper cleaning

and disinfecting. Either an autoclavable syringe tip or a single use disposable

syringe tip may be used.

Cleaning, Disinfecting and Maintenance

Equipment Alert

AUTOCLAVABLE SYRINGE TIP STERILIZATION

The autoclavable syringe tips supplied with the delivery system must be

sterilized prior to use with each patient, including initial use. Be sure to thoroughly

rinse and clean syringe tips prior to sterilization, any debris may reduce the

effectiveness of the sterilization. Recommended sterilization process is steam

autoclave. Recommended parameters are 125°C (250°F) and 106 kPa (15 PSI) for

40 minutes at temperature and pressure.

General Purpose Cleaning

For general purpose cleaning, use cleaners that are appropriate for the

situation, such as warm water and mild detergents, or a 10% solution of

bleach with water.

Visual Inspection

After cleaning, visually inspect the product for deterioration of covers and

touch pads. Do not use the delivery system if excessive discoloration,

cracking, or other signs of wear are noticeable (see Calling for Service

instructions).

Waterline Maintenance

Waterline maintenance is necessary to keep the count of heterotrophic

bacteria from rising higher than desired levels. The desired level for a

specic location should be determined by any local or regional guidelines.

For example, The United States Centers for Disease Control and

Prevention (CDC) guideline for heterotrophic bacteria is less than or equal

to 500 CFU/mL (colony forming units per milliliter). Midmark recommends

keeping this level under 200 CFU/mL.

Treatment can come in many forms. The most popular methods on the

market currently are tablets and straw/cartridge based systems. Midmark

recommends the use of a straw/cartridge based system that keeps the

bacteria levels in check.

Regular monitoring should also take place to ensure that heterotrophic

bacteria is not exceeding the desired limit. If the level is higher than

desired, a shock treatment of the waterlines should be performed. When

performing a shock treatment, be sure to check with the manufacturer of

the regular treatment regimen being used to ensure chemical compatibility.

Monitoring frequency should be established by your practice. As a

suggestion, Midmark would recommend that you begin by monitoring on

a monthly basis, and make adjustments to the frequency based on test

results.

Per the CDC, routine ushing of the waterlines should be performed

between every patient. Extra ushing maybe needed within Midmark

equipment when tablets are used. Undissolved tablet particles can gather

over time in places within the waterlines, obstructing the line and causing

water ow to slow. By ushing the waterlines, water ow is maximized and

should push any undissolved particles through.

Read all labels

carefully!

003-2301-99

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Cleaning and Disinfecting the Delivery System - At the Beginning of Each Day...

Barrier

Cleaning and Disinfecting Assistance

For assistance with cleaning and disinfecting instructions contact the Midmark Technical Service Department at 1-800-Midmark; it is helpful to provide the

delivery system model number and serial number when asking for assistance.

Additional information is available from the organizations listed below:

Organization for Safety & Asepsis Procedures:

http://www.osap.org

Dept. of Health & Human Resources, Centers for Disease Control & Prevention (CDC):

http://www.cdc.gov

American Dental Association:

http://www.ada.org

European Dental Association:

http://www.eda-eu.org

At the beginning of each day...

A) Thoroughly clean and visually inspect the delivery system (See General Purpose Cleaning and

Visible Inspection).

B) Fill the water bottle with fresh water and perform a flush operation (Refer to ICM Screens guide for

more details.)

Note: Use water with a hardness level <60 ppm of calcium carbonate.

C) Install barriers on all delivery system clinician controls.

D) Install syringe tips (sterilized or disposable).

003-2301-99

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Flushing the Delivery System - Between Patients...

Between patients...

A) Remove all disposable barriers, syringe tips, and other dental instruments.

B) Clean and disinfect the delivery system (see Cleaning and Disinfecting instructions).

C) Perform a flush operation (Refer to ICM Screens guide for more details.)

D) Install barriers on all delivery system clinician controls.

E) Install syringe tips (sterilized or disposable).

Barrier

Syringe

Tip

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English - 14

At the end of each day...

A) Remove all disposable barriers, syringe tips, and other dental instruments.

B) Clean and disinfect the delivery system (see Cleaning and Disinfecting instructions).

C) Fill water bottle with fresh water and perform a flush operation (Refer to ICM Screens guide for

more details.)

D) Turn master switch OFF. Press and hold the footpedal until all pressure is released.

Flushing the Delivery System - At the End of Each Day...

Syringe Tip

Handpieces

Barrier

Footpedal

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TP200 20-42-FO-00012 Rev A1 C2169

English - 15

40

60

80

100

20

0

1

2

3

5

6

7

4

0

Air/Oil Separator - Cleaning and Maintaining

Periodically check the air/oil separator...

A) Turn master switch OFF.

B) Remove container by squeezing sides in while pulling out.

C) Remove saturated gauze.

D) Clean container and mounting cap.

E) Install clean gauze and reinstall the container.

Master Switch

Gauze

Air/Oil Separator

Container

Maintaining /Replacing Regulator Filters (in J-box)

Manual Shut

O Valves

Replacing Regulator Filters...

A) Turn off water and air supplies using manual shut off valves.

B) Unscrew filter cap. (Use 9/16” wrench.)

C) Unscrew retainer nut and remove filter and o-ring.

D) Install new filter and o-ring. Secure with retainer nut.

Note: Install the filter and retainer nut with the ridged side up (as shown).

E) Reinstall filter cap.

Retainer

Nut

Filter

O-ring

Filter Cap

003-2301-99

TP200 20-42-FO-00012 Rev A1 C2169

English - 16

WARNING

Equipment is not suitable for use in the presence

of a flammable anesthetic mixture with oxygen, air,

or nitrous oxide.

Clarification: Equipment is suitable for use in the presence

of oxygen, air, or nitrous oxide.

Replacement Parts

Saliva Ejector

Valve

Part Number

029-3975-00

HVE Handpiece

Valve

Part Number

029-3974-00

Solids Collector

Screen

Part Number

(1) 053-1839-00

(50) 002-10260-00

Syringe Tip

Part Number

120514

Saliva Ejector Tip

Part Number

016-1116-00

Regulator Valve

Filter

Part Number

053-1166-00

Saliva Ejector

Lever

Part Number

016-1113-00

HVE Lever

Part Number

016-1109-00

Specications

Electrical Rating for

Elevance Chair:

See power supply output (153941 ...)

Complies to the applicable

requirements of:

ES/IEC/EN 60601-1, CAN/CSA C22.2

No. 60101-1 (Safety Standards), EN/IEC

60601-1-2 (EMC Standards)

Air Supply Requirements: Maximum 80-100 PSI (5.52 - 6.9 bar)

Water Supply

Requirements:

Maximum 30 - 50 PSI (2.1 -3.4 bar)

Use water with a hardness level <60 ppm

of calcium carbonate.

Certications: Midmark Corporation..........ISO-9001

Classications:

Class I, Type B Applied Part, except as

noted for optional accessories, Ordinary

Equipment (IPX0), Continuous Operation

Optional Accessories:

Acteon Satelec Scaler Type BF Applied Part

Acteon Satelec Curing

Light

Type B Applied Part

Acteon Sopro Intra-oral

Camera

Type BF Applied Part

Bien AIr Electric Motor Type BF Applied Part

Dentsply Cavitron Scaler Type B Applied Part

Handpiece tubing and

connectors intended to

be used with ISO 7785-1

or ISO 7785-2 compliant

air-driven handpieces

Type B Applied Part

Sota Claris Intra-oral

Camera

Type B Applied Part

003-2301-99

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Guidance and manufacturer’s declaration – electromagnetic emissions

The Midmark Elevance Unit dental device is intended for use in the electromagnetic environment speci ed below. The customer or the user of the Midmark

Elevance Unit dental device should assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic environment – guidance

RF Emissions CISPR 11 Group 1 The Midmark Elevance Unit dental device uses RF energy only for its internal functions.

Therefore, its RF emissions are very low and are not likely to cause any interference in nearby

electronic equipment.

RF Emissions CISPR 11 Class A The Midmark Elevance Unit dental device is suitable for use in all establishments, including

domestic establishment 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  uctuations/ icker emissions

IEC 61000-3-3

Complies

Recommended separation distances between portable and mobile RF communications equipment and the

Midmark Elevance Unit dental device

The Midmark Elevance Unit dental device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer

or the user of the Midmark Elevance Unit dental device can help prevent electromagnetic interference by maintaining a minimum distance between portable and

mobile RF communication equipment (transmitters) and the Midmark Elevance Unit dental device as recommended below, according to the maximum output

power of the communications equipment.

Radiated maximum output

power of transmitter

W

Separation distance according to frequency of transmitter

m

150 kHz to 80 MHz

d = 1.2 x √P

80 MHz to 800 MHz

d = 1.2 x √P

800 MHz to 2.5 GHz

d = 2.3 x √P

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.34

10 3.69 3.69 7.38

100 11.67 11.67 23.34

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 a ected by absorption and re ection from structures, objects and

people.

EMC - Manufacturer’s Declaration and Guidance

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Guidance and manufacturer’s declaration – electromagnetic immunity

The Midmark Elevance Unit dental device is intended for use in the electromagnetic environment speci ed below. The customer or the user of the Midmark

Elevance Unit dental device should assure that it is used in such an environment.

Immunity Test

IEC 60601

Test Level

Compliance Level Electromagnetic environmental - guidance

Electrostatic discharge (ESD)

IEC 61000-4-2

± 6 kV contact

± 8 kV air

± 6 kV contact

± 8 kV air

Floors should be wood, concrete or ceramic tile. If  oors 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

± 1 kV for input/output

lines

± 2 kV for AC and DC

power lines

I/O lines not tested, all

less than 3 meters

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

environment.

Surge

IEC 61000-4-5

±1kV line(s) to line(s)

±2kV lines(s) to earth

±1kV line(s) to line(s)

±2kV lines(s) to earth

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

<5% U

T

(>95% dip in U

T

for 0.5 cycle)

40% U

T

(60% dip in U

T

for 5 cycles)

70% U

T

(30% dip in U

T

for 25 cycles)

<5% U

T

(>95% dip in U

T

for 5 s)

V Dip >30% of U

T

for 10ms

V Dip < 60% of U

T

for 100ms

V Dip > 95% of U

T

for 5000ms

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

environment. If the user of the Midmark Elevance Unit dental device

requires continued operation during power mains interruptions, it is

recommended that the Midmark Elevance Unit dental device be powered

from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz)

magnetic  eld

IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic  elds should be at levels characteristic of a

typical location in a typical commercial or hospital environment.

NOTE: U

T

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

003-2301-99

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Guidance and manufacturer’s declaration – electromagnetic immunity

Immunity Test IEC 60601

Test Level

Compliance Level Electromagnetic environmental - guidance

Portable and mobile RF communications equipment should be used no

closer to any part of the Midmark Elevance Unit dental device including

cables, than the recommended separation distance calculated from the

equation applicable to the frequency of the transmitter.

Recommended separation distance:

Conducted RF

IEC 61000-4-6

3V rms

150kHz to 80MHz

3V d= 1.2 x √P 80 MHz to 800 MHz

d= 2.3 x √P 800 MHz to 2.5 GHz

Radiated RF

IEC 61000-4-3

3V/m

80MHz to 2.5GHz

3V/m 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 in meters (m).

Field strength from  xed RF transmitters, as determined by the

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:

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 a ected by absorption and re ection from structures, objects and

people.

a

Field strengths from  xed 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  xed RF transmitters,

an electromagnetic site survey should be considered. If the measured  eld strength in the location is which the Midmark Elevance Unit dental device is used

exceeds the applicable RF compliance level above, the Midmark Elevance Unit dental device should be observed to verify normal operation. If abnormal

performance is observed, additional measures may be necessary, such as re-orienting or relocating the Midmark Elevance Unit dental device.

b

Over the frequency range 150kHz to 80MHz,  eld strengths should be less than 3 V/m.

003-2301-99

TP200 20-42-FO-00012 Rev A1 C2169

English - 20

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