Midmark Asepsis 21 User Manual

User GuideUser Guide

Introduction ........................................... 2

Symbols ................................................ 2

Intended Use ........................................ 3

Electromagnetic Interference................ 3

Calling for Service ................................ 3

Specications / Compliance Chart ....... 3

Disposal of Equipment.......................... 3

Transportation / Storage /

Operating Conditions .......................... 3

Manual Shuto Valves /

Pressure Regulator Valves ................ 4

Controls ................................................ 5

Operation ............................................. 7

Cleaning & Maintenance ......................

Chair Mounted Units ......................... 16

Cabinet Mounted Units .................... 17

Doctor’s / Hygienist’s Carts .............. 17

Assistant’s Cart ................................ 18

Left / Right Duo Cart ........................ 18

EMC - Manufacturer’s Declaration and

Guidance ............................................ 19

Warranty Information .......................... 22

Introduction ........................................... 2

Symbols ................................................ 2

Intended Use ........................................ 3

Electromagnetic Interference................ 3

Calling for Service ................................ 3

Specications / Compliance Chart ....... 3

Disposal of Equipment.......................... 3

Transportation / Storage /

Operating Conditions .......................... 3

Manual Shuto Valves /

Pressure Regulator Valves ................ 4

Controls ................................................ 5

Operation ............................................. 7

Cleaning & Maintenance ......................

Chair Mounted Units ......................... 16

Cabinet Mounted Units .................... 17

Doctor’s / Hygienist’s Carts .............. 17

Assistant’s Cart ................................ 18

Left / Right Duo Cart ........................ 18

EMC - Manufacturer’s Declaration and

Guidance ............................................ 19

Warranty Information .......................... 22

midmark.com

Asepsis 21® Delivery Systems

English Español Français

Style P

TP202 20-42-FO-00014 Rev A1 C2169

003-2237-99 Rev CA6 (7/19/19)

Introduction

Your Asepsis 21 Delivery system has been designed and manufactured with care and you in mind. It is constructed of the highest quality material to provide years of trouble-free service.

The instrument head provides for the control of up to ve air operated handpieces and a 3-way syringe. The handpieces are stored in their respective holders

which may be rotated to your preferred position. When the handpiece is removed from the holder, it is automatically selected to operate when the foot control is depressed.

Your new Asepsis 21 also features a handpiece lubricant collection system. The handpiece exhaust tubes from the four port handpiece tubes are connected to a collector jar which is located on the bottom center of the instrument head. The collection jar can be removed to be emptied and cleaned simply by unscrewing it from the unit. The collector jar should be inspected daily and emptied when approximately 1/2 inch of oil has accumulated.

The aerodynamic shape of the instrument head lends itself to easy cleaning or wrapping for infection control.

Symbols

These symbols may appear on your equipment and/or in the manuals Warning and cautions are provided in the manuals where applicable.

WARNING

Indicates a potentially hazardous situation which could result in serious injury 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

Equipment Alert

Indicates a potentially hazardous situation which could result in equipment damage if not avoided.

NOTE

Amplifies a procedure, practice, or condition.

Type B, Applied Part

Type BF, Applied Part

Protective Earth Ground

Proper Shipping Orientation

Fragile

Catalogue Number

Serial Number

Manufacturer

Refer to instruction manual/booklet

Pressure Limit

100 F

Temperature

38 C

23 F

-5 C

Limit

Humidity Limit

Maximum stacking height (Refer to “n”

number on package.)

Keep Dry

003-2237-99

English - 2

TP202 20-42-FO-00014 Rev A1 C2169

Intended Use

Midmark delivery systems are intended to provide dental professionals with air, water and suction to operate dental handpieces, syringes, and Midmark authorized accessories during dental examinations and procedures.

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.

Calling For Service

Direct all service inquiries to your authorized Midmark dealer. When calling for service, you must provide the following information:

Specications

Air / Water Pressure Operating Ranges:

Classications Class I, Type B, Applied Part,

Optional Accessories: Handpiece tubing and connectors intended

to be used with ISO 7785-1 or ISO 7785-2 compliant air-driven handpieces

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.

Air: 80/100 PSI Water: 30/50 PSI

Ordinary Equipment. [IPXO]

Type B Applied Part

Model / serial number Date of purchase Symptom(s) of malfunction

Description

Asepsis 21 Delivery Systems Ultra Chair

Asepsis 21 Delivery Systems

Mounted on

(Type)

Knight Chair

or Carts

60601-1

(2nd

Edition)

• •

CAN / CSA

22.2,

#601.1 - M90

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)

Complies To: Electrical Ratings:

ES/IEC/

60601-1

• • •

60601-1-2

(EMC Standards)

CAN / CSA

22.2,

#60601.1

Volt

+/- 10%

120 15 A 50/60 240 7.5 A 50/60

Maximimum

Connected

Load

N/A

Cycles

(Hz)

Power Supply Model No.: 153808-001, -002

003-2237-99

English - 3

TP202 20-42-FO-00014 Rev A1 C2169

Manual Shut-O Valves / Pressure Regulator Valves

Manual shut-o󰀨 valves allow you to stop the air and/or water supply at the point of input to the operatory. This is recommended during extended periods of non-use (ex. vacation, holidays, etc.), or in the event of an equipment malfunction.

Pressure regulator valves allow you to control the air and water pressure supplied to the instruments of the delivery system.

Water Bottle Regulator DO NOT ADJUST

Air Regulator Gauge

Air Regulator Adjustment Knob

100

City Water Gauge

City Water Regulator Adjustment Knob

Water Manual

Shut-o Valve

Air Manual

Shut-o Valve

Shut-o Valves

Rotate clockwise 1/4

turn to Shut o.

To Adjust the Pressure Regulators...

A) Pull up knob and turn to adjust. B) Watch regulator gauge as you turn knob to achieve desired setting.

Turn Clockwise for more pressure

Turn Counter-Clockwise for less pressure

Recommended Settings:

City Water RegulatorGauge Setting

Air Pressure RegulatorGauge Setting

Water Bottle Regulator Setting

003-2237-99

30 psi

80 psi

Factory set to 30 psi DO NOT adjust

Equipment Alert

Delivery components were designed to operate at the recommended settings. Poor performance or damage to the equipment may result if recommended settings are not maintained.

English - 4

100

KA947002

TP202 20-42-FO-00014 Rev A1 C2169

Controls

Asepsis 21 Instrument Head: A complete set of handpiece and syringe adjustments are located directly under the magnetically held cover for protection against contamination. Lift up either back corner of the cover for easy removal. All controls are labeled with symbols identifying their function.

1 2 3

Handpiece Coolant Water Volume

Adjusts the amount of coolant water to each respective handpiece.

4 5 6

Drive Air Pressure Setting

Individual adjustments are provided - one for each respective handpiece. Set the maximum handpiece pressure indicated on the gauge. Refer to the handpiece manufacturer’s

specications for proper setting.

Syringe Air Volume Adjustment

Controls the volume of air to the syringe and

e󰀨ects water spray pattern.

Coolant Air Volume Adjustment

This adjustment controls the volume of coolant

delivered to each handpiece. It a󰀨ects the

spray pattern of air and water at the handpiece. If the handpiece has a coolant air connection in the handpiece itself, this adjustment will have

no e󰀨ect and can be completely shut o󰀨.

Handpiece Pressure Gauge

Indicates individual handpiece pressure when the handpiece is operating.

11 12 13

Magnetic Latches

These hold the cover in place.

Syringe Water Volume Adjustment

Controls the volume of water to the syringe and

e󰀨ects water spray pattern.

003-2237-99

English - 5

Handpiece Coolant Water Flush Button

Controls the coolant water ush valve and is located

on the underside of the delivery head.

TP202 20-42-FO-00014 Rev A1 C2169

Controls - continued

External Controls

Main ON / OFF Valve

Located on the bottom center of the instrument head directly behind the handpiece holder bar support, this two position toggle control turns the main air and water ON / OFF.

(See illustration below)

Water Outlet and Flow Control

Located on the front panel of the console, the water outlet provides water for hydrocolloid tubing or other accessories. The water is

controlled by a ow control knkob located next

to the water outlet. Turning the knob clockwise

decreases water ow, and counterclockwise increases the ow.

Automatic Handpiece Activation

The automatic kink valves are designed to permit activation of the selected handpiece when it is removed from its holder. Drive air will be delivered to the withdrawn handpiece when the foot control is depressed.

Blue dot indicates

“wet” operation

Water ON / OFF Valve

Located on the foot control, this switch provides water for coolant spray to the handpiece when the switch is moved forward to the ON position (toward the blue dot) and the foot control is depressed (wet cutting). When the valve is in the OFF position, water will not be delivered to any handpiece. (See illustration below).

Arm Lock (chair mtd. units only)

Located on the bottom of the instrument head adjacent to the handle, this two position toggle controls the arm lock mechanism.

Assistant’s Instrumentation

A saliva ejector, HVE and syringe are standard instrumentation on the unit. They are positioned on a movable holder located on the console. Syringe tip, saliva ejector valve assembly and HVE valve assembly are easily removed for sterilization.

Water Selector Switch

This switch, located on the front of the console or the LR arm, allows you to choose the water source for the delivery system. You may select either “City” water (tap water), or water from the Self-Contained Water System bottle.

“City” water

Self-Contained Water System

003-2237-99

Wet / Dry Foot Control

The disc-type foot control operates the selected handpiece at varying speeds depending upon the foot pressure applied to the disc. Positioning the coolant water selector toggle allows coolant water for wet cutting to be selected by the motion of the foot. Applying foot pressure to the disc will operate the selected handpiece and, if turned ON, water spray. (See illustration below).

English - 6

TP202 20-42-FO-00014 Rev A1 C2169

Operation

Basic Operation:

Step 1: Turn ON the master valve lever located on the underside of the Asepsis 21 instrument head.

Step 2: Flip the wet/dry toggle on the foot control to the desired position.

Step 3: Lift the handpiece from its holder and depress the foot control.

003-2237-99

Step 4: If necessary, make adjustments by lifting the cover off the Asepsis 21 head and adjusting the control knobs as desired. (See Controls section)

English - 7

TP202 20-42-FO-00014 Rev A1 C2169

Cleaning, Disinfecting & Maintenance

Read all labels

ATTENTION

Midmark assumes no responsibility or liability for any result, expressed or implied. These are suggested practices, based on the best information available at this time this is written..

Scheduled Maintenance Chart

Area Frequency

Unit surfaces as necessary Hoses as necessary Vacuum system as necessary Solids collector daily Regulator lters (air / water) every 3 months

Barriers

Single-use barriers and disposable items signicantly reduce the need for chemical disinfectants, thus prolonging the life of the equipment. Barrier material must be impervious to moisture / uids.

Examples of protective barriers:

Barrier

DA178400i

Cleaning and Disinfectant Procedures

Use cleaners and disinfectants that are appropriate for the situation, such as warm water and mild detergents, or a 10% solution of bleach with water.

NOTE

Every dental practice is di󰀨erent, and no single disinfectant is the best choice for every facility. Listed

below are some organizations to assist you in choosing the best disinfectants available for your practice.

003-2237-99

• Plastic covers (available from your dealer or equipment manufacturer)

• Clear plastic wrap

• Plastic bags

• Plastic sheets

• Plastic tubing

• Plastic-backed paper

• Materials similar to those listed here

English - 8

carefully!

• Organization for Safety & Asepsis Procedures:

http://www.osap.org

• American Dental Association:

http://www.ada.org

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

http://www.cdc.gov

• European Dental Association:

http://www.eda-eu.org

TP202 20-42-FO-00014 Rev A1 C2169

Cleaning, Disinfecting & Maintenance (continued)

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.

General Purpose Cleaning

Use cleaners and disinfectants that are appropriate for the situation, such as warm water and mild detergents, or a 10% solution of bleach with water.

Visual Inspection

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.

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.

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.

003-2237-99

English - 9

TP202 20-42-FO-00014 Rev A1 C2169

DA101201i

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

American Dental Association:

http://www.ada.org

Cleaning the Delivery System

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

http://www.cdc.gov

European Dental Association:

http://www.eda-eu.org

At the beginning of each day...

Fill the Self contained water bottle with fresh water and perform a Purging Procedure.

Note: See Purging Procedure described in this manual.

Note:

Water must be safe for drinking. Distilled water is not required.

For each new patient...

Replace disposable tips, instruments, etc. and perform a Purging Procedure.

Note: See Purging Procedure described in this manual.

003-2237-99

DA2536i

English - 10

TP202 20-42-FO-00014 Rev A1 C2169

Cleaning the Delivery System - At the end of each day...

A) Remove disposable tips, instruments, etc.

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

DA2536i

C) Fill the water bottle with fresh water and perform a perform a purging procedure.

Note: See Purging Procedure described in this manual.

003-2237-99

English - 11

D) Turn Master Switch OFF. Press and hold the foot control pedal until all pressure is released.

DA2538i

TP202 20-42-FO-00014 Rev A1 C2169

DA255901i

Purging Procedure for the Delivery

NOTE:

The purging procedure removes debris from the tubing to the handpieces and syringe. Performing this procedure frequently may help reduce the accumulation of biofilm on your instruments.

To begin the purging procedure...

A) Turn Master Switch ON. B) Turn Water Selector Switch to bottle setting C) Move the foot control switch to the water setting. D) Disconnect handpiece from tubing.

Master Switch

SLIDE

Position

Water Selector Switch

Flush the tubing to the handpieces ...

A) Press and hold the foot control pedal for 30 seconds. B) Press and hold the flush button for 30 seconds. C) Repeat for all tubing to the handpieces.

Water

Caution

Hold the tubing and syringe over a container or drain while flushing.

003-2237-99

Flush the Syringe Tubing...

A) Press and hold both syringe buttons (air and water) for 30 seconds.

English - 12

Foot Control Switch

TP202 20-42-FO-00014 Rev A1 C2169

Air/Oil Separator - Cleaning and Maintaining

Periodically check the uid level in the air / oil separator container.

When the container is approximately 2/3 full, clean the air/oil separator as shown below.

To clean the air/oil separator...

A) Turn master ON/Off switch Off. B) Remove (unscrew) air/oil separator container.

C) Dispose of the fluid and saturated gauze. D) Disinfect container and mounting cap. E) Install clean gauze and reinstall the container.

003-2237-99

English - 13

TP202 20-42-FO-00014 Rev A1 C2169

Maintaining and Replacing the Regulator Filters

100

Step 1: Shut off manual valves to turn off water and air supplies to the operatory.

100

Manual Shut

O Valves

Step 3: Unscrew retainer nut and remove filter.

Step 2: Unscrew filter cap.

Note: Use 9/16” wrench.

003-2237-99

Retainer Nut

Filter Cap

English - 14

Filter

KA947500

Step 4: Install new filter. Secure with retainer nut.

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

Step 5: Reinstall filter cap.

TP202 20-42-FO-00014 Rev A1 C2169

Assistant’s Units - Cleaning

To clean the facility vacuum system...

Refer to the instructions provided by the vacuum system’s manufacturer.

To clean the solids collector...

A) Turn facility vacuum OFF. B) Remove lid and basket. C) Clean basket and housing. D) Reinstall basket and lid.

Note:

Every dental practice is different, and no single disinfectant is the best choice for every facility. See the list of organizations that may assist you in choosing the best disinfectants available for your practice, in the front of this manual.

Caution

Always dispose of biohazardous debris according to local regulations.

003-2237-99

English - 15

DA178800i

TP202 20-42-FO-00014 Rev A1 C2169

Dimensions / Range of Motion

Chair Mounted Units

Maximum load on Flex Arm mounted units is 7 lbs (3.2 KG)

18.12"

14.3"

Asepsis 21 Delivery Head

003-2237-99

CONCEPT LR UNIT CHAIR MOUNTED CONSOLE UNIT

English - 16

TP202 20-42-FO-00014 Rev A1 C2169

KA940200

Dimensions / Range of Motion - continued

18.15"

18.86"

13.00"

28.25" TO

36.75"

16.50"

AF 1119

Cabinet Mounted Units Doctor’s / Hygienist’s Carts

003-2237-99

English - 17

TP202 20-42-FO-00014 Rev A1 C2169

Dimensions / Range of Motion - continued

Assistant’s Cart Left / Right Duo Cart

003-2237-99

English - 18

TP202 20-42-FO-00014 Rev A1 C2169

EMC - Manufacturer’s Declaration and Guidance

Guidance and manufacturer’s declaration – electromagnetic emissions

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

Procenter 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 Procenter 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 Procenter Unit dental device is suitable for use in all establishments, including

Harmonic emissions IEC 61000-3-2 Class A

domestic establishment and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Voltage  uctuations/ icker emissions

IEC 61000-3-3

Complies

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

Midmark Procenter Unit dental device

The Midmark Procenter 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 Procenter Unit dental device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and the Midmark Procenter Unit dental device as recommended below, according to the maximum output power of the communications equipment.

Radiated maximum output

power of transmitter W

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.

150 kHz to 80 MHz

d = 1.2 x √P

Separation distance according to frequency of transmitter m

80 MHz to 800 MHz

d = 1.2 x √P

800 MHz to 2.5 GHz

d = 2.3 x √P

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.

003-2237-99

English - 19

TP202 20-42-FO-00014 Rev A1 C2169

Guidance and manufacturer’s declaration – electromagnetic immunity

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

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

Immunity Test

Electrostatic discharge (ESD) IEC 61000-4-2

Electrical fast Transient / burst IEC 61000-4-4

Surge IEC 61000-4-5

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

IEC 60601 Test Level

± 6 kV contact

± 8 kV air

± 2 kV for power supply lines

± 1 kV for input/output lines

±1kV line(s) to line(s)

±2kV lines(s) to earth

<5% U (>95% dip in U

for 0.5 cycle)

40% U

(60% dip in UT for 5 cycles)

70% UT (30% dip in UT for 25 cycles)

Compliance Level Electromagnetic environmental - guidance

± 6 kV contact

Floors should be wood, concrete or ceramic tile. If  oors are covered with

synthetic material, the relative humidity should be at least 30%.

± 8 kV air

± 2 kV for AC and DC power lines

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

I/O lines not tested, all less than 3 meters

±1kV line(s) to line(s)

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

±2kV lines(s) to earth

V Dip >30% of UT for 500ms

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Midmark Procenter Unit dental device requires continued operation during power mains interruptions, it is

V Dip < 60% of UT for 100ms

recommended that the Midmark Procenter Unit dental device be powered from an uninterruptible power supply or a battery.

V Dip > 95% of UT for 5000ms and 10ms

Power frequency (50/60 Hz)

magnetic  eld

IEC 61000-4-8

NOTE: U

003-2237-99

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

<5% UT (>95% dip in UT for 5 s)

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.

English - 20

TP202 20-42-FO-00014 Rev A1 C2169

Guidance and manufacturer’s declaration – electromagnetic immunity

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

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

Immunity Test

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

IEC 60601 Test Level

3V rms 150kHz to 80MHz

3V/m 80MHz to 2.5GHz

Compliance Level Electromagnetic environmental - guidance

Portable and mobile RF communications equipment should be used no closer to any part of the Midmark Procenter Unit dental device including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance:

3V d=1.2 x √P

3V/m d= 1.2 x √P 80 MHz to 800 MHz

d= 2.3 x √P 800 MHz to 2.5 GHz

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,

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.

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 Procenter Unit dental device is used

exceeds the applicable RF compliance level above, the Midmark Procenter 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 Procenter Unit dental device.

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

003-2237-99

English - 21

TP202 20-42-FO-00014 Rev A1 C2169

Warranty Information

Midmark Limited Warranty - Dental Products

SCOPE OF WARRANTY

Midmark Corporation (“ Midmark”) warrants to the original retailpurchaser that it will atMidmark's option repair or replace components ofthe dentalproducts manufactured byMidmark (exceptfor componentsnot warranted under "Exclusions") that are defective in material or workmanship under normal use and service. Midmark'sobligation under this limite d warranty is limited to the repair or replacement of the applicable components.This limited warranty shall only apply to defectsthat are reported to Midmark within the applicable warranty period and which, upon examination by Midmark, prove to bedefective. This warranty extends onlyto the fir st retail purchaser of a product and is not transferable or assignable. Replacement components or products may be used and/or refurbished componentsor products,provided they are of like quality and specificationsas new componentsor products.

APPLICABLE WARRANTY PERIOD

The applicable warranty period, measured from the dateof delivery to the originaluser, shall be as follo ws: EffectiveMarch 1, 2018these applicable warranty periods are measured from the date of invoice to the original user, shall be as follows:

1. OPERATORY PRODUCTS

a. Five (5) years for all products (except for the items in (b) through (e)).

b. Two(2) years for upholstery (chairs and stools) .

c. “KINK-VALVE” module carriesa ten(10) year warranty.

d. The original light bulb on a new light carries a one (1) year warranty.

e. Accessorie s notmanufactured byMidmark are excluded including but not limited to Bien Air

handpiecesystems, DentsplyCavitron scaler, Satelec scaler and curing light, and Sopro cameras.

2. ORAL SURGERY PRODUCTSare warranted for a periodof one(1) year.

3. STERILIZER PRODUCTS are warranted for a period of one (1) year.

4. ULTRASONIC CLEANER PRODUCTS are warranted for a period of two (2) years.

5. AIR AND VACUUM PRODUCTS

a. PowerAir® oil- less compressors– Five (5) years or 3,500 hours of use, whichever occurs first.

b. PowerVac® andPowerVac® G dry vacuums – Five (5) years or 10,000 hours of use,

whichever occurs fir st (except that the vacuum pump warranty term is ten (10) yearsor 20,000 hours of use, whichever occur s first).

c. Classic Series®wet-ring vacuums – F ive (5) years or 10,000 hours of use,whichever occurs

first.

d. PowerMax surgicalsuction – Two (2) years.

e. Hg5 Series Amalgam Separator - One (1) year.

(1) year.

6. SYNTHESIS™ DENTAL CASEWORK AND ARTIZAN® EXPRESSIONS PRODUCT

a. Five (5) years for all products and components including door and drawer fronts, caster s and

slides, except for the items in (b), (c) and (d).

b. Three ( 3) years for electricalcomponentssuch as task lights/LED lights, cords, controlsand

accessories.

c. Two (2) years for sliding track monitor mount and components and upholstery. (d) One (1)

year for countertopsand resin, including accessories.

(f) Midmark manufactured accessor ies - One

7. IMAGING PRODUCTS are warranted for a period of two (2) years except for the ClearVision CR reader which is warranted for a period of one ( 1) year.

8. MIDMARK Replacement Parts andAccessories carry a ninety (90) day warranty

EXCLUSIONS

Th is warranty does not cove r and Midmark shall not be liab le for the following;

defects,damage or other conditions caused, in whole or in part, by misuse, abuse, negligence, alteration,accident, freight damage, negligent storage, tampering or failur e to seekand obtain repair or replacementin a timely manner;

products which are not installed, used, and properly cleaned and maintained as required or recommended in the Midmark "Installation" and/or "Installation/OperationManual" for the applicable product, including the specified structural and operationalenvironment conditions and electrical power requirements;

products considered to be of a consumable or sterile nature;

accessories or parts not manufactured by Midmar k;

charges by anyone for adjustments,repairs, replacement parts, installa tion or other work performed upon or in connection with such products which are not expre ssly authorized in wr itin g in advance byMidmark

costs and expenses of routine maintenance and cleaning;

representations and warranties made by any per son or entity other than Midmark;

matchingof color, grain or texture except to commer cially acceptable standards;

changesin color caused by natural or artificial light ;

10.

custom manufactured products;

11.

alterationsor modifications to the product by anyperson or entity other than Midmark; and

12.

Products that wouldotherwise by covered under Sections1 and2 ofthis limited warranty, but are acquired: (i) from a person or entity that is notMidmark or one ofits authorizeddealers; or (ii) from a Midmark dealer that is not authorized to sell the product at issue in the geographic territorywhere the purchaser is located, or is not authorized to sell the product at issue with in the medical, animal purchaser intendsto use the product.

EXCLUSIVE REMEDY; CONSEQUENTIAL DAMAGES DISCLAIMER

MIDM ARK'S ONLY OBLIGAT ION UNDER THIS LIMITED WARRANTY IS THE REPAIR OR REPLACEMENT OF D EFECTIVE PARTS. MIDMARK SHALL NOT BE LIABLE F OR AND HEREBY DISC LAIMS ANY DIRECT, SPECIAL, INDIRECT, INCIDENTAL, EXEMPLARY OR CONSEQUEN TIAL DAMAGES OR DELAYS, INCLUDING, BUT NOT LIMITED TO, D AMAGES FOR L OSS OF PROFITS OR INCOME, LOSS OF USE, DOWNTIME, COVER AND EMPLOYEE OR INDEPENDENT CONTRACTOR WAGES, PAYMENT S AND BENEFIT S.

WARRANTY DISCLAIMER

THIS LIMIT ED WARRANTY IS MIDMARK'S ON LY WARRANTY AND IS IN LIEU OF ALL OT HER WARRAN TIES, EXPRESS OR IMPLIED.MIDMARK MAKES NO IMPLIED WARRAN TIES OF ANY KIND INCLUDING ANY IMPLIED WARRAN TIES OF MERC HANTABIL ITY OR FIT NESS FOR A PARTICULAR PURPOSE. THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT OF DEFECTIVE PARTS.

STATUTE OF LIMITATIONS

No action my be brought against Midmark for breach of this limited warranty, or implied warranty, if any, or for any other claim ar ising out of or relating to the products, more than ninety (90) days follo wing expiration of the limited w arranty period.

health or dental market, asthe case may be, in which

003-2237-99

English - 22

TP202 20-42-FO-00014 Rev A1 C2169

+ 50 hidden pages

Midmark Asepsis 21 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual