MIDMARK

Progeny Dental Products and Systems

Asepsis 21 Delivery Systems User Guide Rev D April 2013

User Guide

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File Name: MIDMARK - Asepsis 21 Delivery Systems User Guide Rev D April 2013 - 2013-04.pdf

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Page 1

User Guide

Asepsis 21® Delivery Systems

Introduction... 2 Labels & Symbols... 2 Intended Use... 3 Electromagnetic Interference... 3 Calling for Service... 3 Specifications / Compliance Chart ... 3 Disposal of Equipment... 3 Transportation / Storage / Operating Conditions... 3 Manual Shutoff 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 Warranty Information... 19

Language of origin: English

0086 Refer to compliance chart in this manual.

Asepsis-1

Part No. 003-2237-00 Rev. D (4/23/13)

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 five 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. Consult Manuals

Type B, Applied Part

warning

Indicates a potentially hazardous situation which could result in serious injury if not avoided.

Pressure Limit

Type BF, Applied Part

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.

100 F

Protective Earth Ground

38 C

Temperature Limit

23 F -5 C

Proper Shipping Orientation

Humidity Limit

Fragile

Maximum stacking height (Refer to “n” number on package.)

NOTE

Amplifies a procedure, practice, or condition. Keep Dry

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Intended Use

Specifications

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.

Air / Water Pressure Operating Ranges:

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

Classifications

Class I, Type B, Applied Part, Ordinary Equipment. [IPXO]

Optional Accessories:

Electromagnetic Interference

Handpiece tubing and connectors intended to be used with ISO 7785-1 or ISO 7785-2 compliant air-driven handpieces

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.

Type B Applied Part

warning

Equipment is not suitable for use in the presence of a flammable anesthetic mixture with oxygen, air, or nitrous oxide.

Calling For Service

Clarification: Equipment is suitable for use in the presence of oxygen, air, or nitrous oxide.

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

Disposal of Equipment

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

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.

Authorized CE Representative Countries in the EEC should direct all questions, incidents, and complaints to Midmark’s Authorized CE representative listed below. Midmark Europe SAS 22, Rue De St. Denis 53500 Ernee, FRANCE Phone: 33-2-430-517-76 Fax: 33-2-430-569-10

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:

Description

Mounted on (Type)

Asepsis 21 Delivery Systems

Ultra Chair

Asepsis 21 Delivery Systems

Knight Chair or Carts

UL 60601-1 (2nd Edition)

•

CAN / CSA 22.2, #601.1 - M90

Electrical Ratings:

ES/IEC/ EN 60601-1

EN 60601-1-2 (EMC Standards)

CAN / CSA 22.2, #60601.1

•

• Asepsis-3

Volt +/- 10%

Maximimum Connected Load

Cycles (Hz) Power Supply Model No.: 153808-001, -002

N/A 120

15 A

50/60

240

7.5 A

50/60

Manual Shut-Off Valves / Pressure Regulator Valves Manual shut-off 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.

City Water Gauge

Water Bottle Regulator DO NOT ADJUST

City Water Regulator Adjustment Knob

Shut-off Valves Rotate clockwise 1/4 turn to Shut off.

Air Regulator Adjustment Knob Water Manual Shut-off Valve

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.

3 4

5 0

6 7 100

Air Manual Shut-off Valve

Air Regulator Gauge

Turn Clockwise for more pressure

Turn Counter-Clockwise for less pressure

Recommended Settings:

Water Bottle Regulator Setting

Factory set to 30 psi DO NOT adjust

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.

4 5

Air Pressure 80 psi RegulatorGauge Setting

Equipment Alert

6 7 0

10 0

City Water 30 psi RegulatorGauge Setting

KA947002

Asepsis-4

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.

9 Coolant Air Volume Adjustment

Handpiece Coolant Water Volume

This adjustment controls the volume of coolant delivered to each handpiece. It affects 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 effect and can be completely shut off.

Adjusts the amount of coolant water to each respective handpiece.

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 specifications for proper setting.

Handpiece Pressure Gauge Indicates individual handpiece pressure when the handpiece is operating.

Syringe Air Volume Adjustment

Magnetic Latches

Controls the volume of air to the syringe and effects water spray pattern.

These hold the cover in place.

8 14

Syringe Water Volume Adjustment

Handpiece Coolant Water Flush Button

Controls the volume of water to the syringe and effects water spray pattern.

Controls the coolant water flush valve and is located on the underside of the delivery head.

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Controls - continued External Controls Main ON / OFF Valve

Arm Lock (chair mtd. units only)

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)

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

Assistant’s Instrumentation

Water Outlet and Flow Control

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.

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 flow control knkob located next to the water outlet. Turning the knob clockwise decreases water flow, and counterclockwise increases the flow.

Water Selector Switch

Automatic Handpiece Activation

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.

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.

“City” water

Water ON / OFF Valve

Blue dot indicates “wet” operation

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).

Self-Contained Water System

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).

Asepsis-6 DA

Operation 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. (See the illustration) 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.

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)

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Cleaning, Disinfecting & Maintenance 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..

Barrier

Scheduled Maintenance Chart Area

Frequency

Unit surfaces

as necessary

Hoses

as necessary

Vacuum system

as necessary

Solids collector

daily

Regulator filters (air / water)

every 3 months

Barrier Barrier DA178400i

Barriers Single-use barriers and disposable items significantly reduce the need for chemical disinfectants, thus prolonging the life of the equipment. Barrier material must be impervious to moisture / fluids. Examples of protective barriers: Read all labels carefully!

• 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

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Cleaning, Disinfecting & Maintenance (continued) Barriers

General Purpose Cleaning

Midmark recommends the use of disposable barriers on all clinician controls that may be in contact with clinician hands and fingers during dental procedures. The use of barriers significantly reduces the need for chemical cleaners, thus prolonging the life of the equipment.

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.

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.

Visual Inspection

Cleaning and Disinfecting

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).

Cleaning and Disinfecting Assistance

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.

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:

Handpiece Accessories

• Organization for Safety & Asepsis Procedures http://www.osap.org

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.

• American Dental Association: http://www.ada.org

• European Dental Association: http://www.eda-eu.org

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.

• Dept. of Health & Human Resources Centers for Disease Control & Prevention (CDC): http://www.cdc.gov

Asepsis-9

Cleaning the Delivery System

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.

DA101201i

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.

DA2536i

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

B) Mix approximately 10% bleach (use only 5.25% bleach solution) with 90% water.

A) Remove disposable tips, instruments, etc.

Use only 5.25% bleach solution. Do not use bleach with scents, color guards, or other additives. Mix fresh every day.

Note: Use fill marks on the newer Midmark water bottles for quick measures..

DA2536i

C) Perform a purging procedure. Leave the bleach mixture in the system for 10 - 20 minutes, then remove. Empty and rinse the water bottle Note: See Purging Procedure described in this manual.

~90% ~10%

D) Fill the water bottle with fresh water and perform a purging procedure. Repeat as many times as needed, until all the bleach odor is gone.

Equipment Alert

Do not leave bleach mixture in system longer than 30 minutes. Doing so may damage the delivery system .

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

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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...

Flush the tubing to the handpieces ...

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.

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.

Master Switch

SLIDE

ON Position

Water Selector Switch Water

Foot Control Switch

Flush the Syringe Tubing... Caution

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

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

Asepsis-12

Air/Oil Separator - Cleaning and Maintaining Periodically check the fluid 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.

Asepsis-13

Maintaining and Replacing the Regulator Filters Step 1:

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

Manual Shut Off Valves

4 5

6 7

100

3 4

5 0

6 7 100

Step 3:

Unscrew retainer nut and remove filter.

Retainer Nut

Filter

Unscrew filter cap.

Note: Use 9/16” wrench.

Step 5: KA947500

Install new filter. Secure with retainer nut.

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

Filter Cap

Step 2:

Step 4:

Asepsis-14

Reinstall filter cap.

Assistant’s Units - Cleaning

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.

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.

Caution

Always dispose of biohazardous debris according to local regulations.

DA178800i

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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 KA940100

CONCEPT LR UNIT

Asepsis-16

CHAIR MOUNTED CONSOLE UNIT

KA940200

Dimensions / Range of Motion - continued Cabinet Mounted Units

Doctor’s / Hygienist’s Carts

16.50"

18.15"

18.86"

28.25" TO 36.75"

13.00"

Asepsis-17

AF1119

Dimensions / Range of Motion - continued Assistant’s Cart

Left / Right Duo Cart

Asepsis-18

Warranty Information SCOPE OF WARRANTY

Midmark Corporation (“Midmark”) warrants to the original purchaser its Dental products and components (except for componentsnot warranted under “Exclusions”) manufactured by Midmark to be free from defects in material and workmanship under normaluse and service. Midmark’s obligation under this warranty is limited to the repair or replacement, at Midmark’s option, of the parts or the products the defects of which are reported to Midmark within the applicable warranty period and which, upon examination by Midmark prove to be defective.

INTEGRA™ DENTAL CASEWORK AND ARTIZAN™ DENTAL FURNITURE PRODUCTS are warranted against defect in material and workmanship for the period indicated below from the time of delivery: (a) Five (5) years for all products and components (except for the shorter periods in (b and c), including plastic laminate top surfaces, door and drawer fronts, casters, and electrical components such as task lights and cords. (b) Three (3) years for task light ballast. (c) One year (1) for plastic laminate, solid surface countertops and accessories.

APPLICABLE WARRANTY PERIOD

EXCLUSIONS

The applicable warranty period, measured from the date of delivery to the original user, shall be as follows:

This warranty does not cover and Midmark shall not be liable for the following;

DENTAL PRODUCTS are warranted against defect in material and workmanship for the period indicated below from the time of delivery: (a) Two (2) years for all products and components (except for the periods in b thru e). (b) “KINK-VALVE” module carries a ten (10) year warranty. (c) The original light bulb on a new light carries a one (1) year warranty. (d) Accessories not manufactured by Midmark are excluded. (e) Replacement parts and accessories carry a ninety (90) day warranty.

EXCLUSIVE REMEDY

Oral Surgery PRODUCTS are warranted against defect in material and workmanship for a period of one (1) year from the time of delivery.

STERILIZERS PRODUCTS are warranted against defect in material and workmanship for a period of one (1) year from the time of delivery.

ULTRASONIC CLEANER PRODUCTS when used in accordance with manufacturer’s instructions and under normal use, are guaranteed for two (2) years after date of shipment. Within the period guaranteed, the manufacturer will repair or replace free of charge, at its sole discretion, all parts that are defective because of material or workmanship including costs for removing or installing parts. Repairs are made on a FOB repair depot basis. Manufacturer’s liability, whether based on warranty, negligence or other cause, arising out of and/or incidental to sale, use or operation of the transducer elements, or any part thereof, shall not in any case exceed the cost of repair or replacement of the defective equipment, and such repair or replacement shall be the exclusive remedy of the purchaser, and in no case shall manufacturer be responsible for any and/or all consequential or incidental damages including without limitation, and/or all consequential damages arising out of commercial losses.

(1) repairs and replacements because of misuse, abuse, negligence, alteration, accident, freight damage, or tampering; (2) matching of color, grain, or texture except to commercially acceptable standards; (3) changes in color caused by natural or artificial light; (4) products which are not installed, used, and properly cleaned as required in the Midmark “Installation” and or “Installation/Operation” Manual for this applicable product; (5) products considered to be of a consumable nature; (6) accessories or parts not manufactured by Midmark; (7) specially manufactured products; (8) charges by anyone for adjustments, repairs, replacement parts installation, or other work performed upon or in connection with such products which is not expressly authorized in writing in advance by Midmark.

Midmark’s only obligation under this warranty is the repair or replacement of defective parts. Midmark shall not be liable for any direct, special indirect, incidental, exemplary or consequential damages or delay including, but not limited to, damages for loss of profits or loss of use. NO AUTHORIZATION No person or firm is authorized to create for Midmark any other obligation or liability in connection with the products.

THIS WARRANTY IS MIDMARK’S ONLY WARRANTY AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED. MIDMARK MAKES NO IMPLIED WARRANTIES OF ANY KIND INCLUDING ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE. THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT OF DEFECTIVE PARTS.

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