Aseptico AMC-25 User Manual

AMC 25

Mobile Dental System

OPERATION & MAINTENANCE MANUAL

AMC-25

SAFETY PRECAUTIONS

To prevent injury to people and damage to property, please heed relevant warnings and remarks. They are marked as follows:

•WARNING: Serious injury or death may result if ignored.

•CAUTION: Damage to property or the environment may result if ignored.

•NOTE: Important additional information and hints.

Aseptico accepts no liability for direct or consequential injury or damage resulting from improper use, arising in particular through the non-observance of the operating instructions, or improper preparation and maintenance.

sWARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

sWARNING: Connecting electrical equipment to this device creates a Medical Electrical (ME) system. If connecting equipment that is not part of the ME system, have a trained service person evaluate the ME system to ensure safety leakage currents are maintained per IEC 60601-1.

sWARNING: It is not recommended to connect multiple socket outlets or extension cords to this device.

sWARNING: Clean, disinfect, and sterilize new or repaired handpieces and instruments before first use and between each patient use. Only use sterilized handpieces and instruments during treatment. Non-sterilized handpieces and instruments may cause bacterial or viral infections. Always sterilize handpieces and instruments after operation.

sCAUTION: Always examine unit components for damage before commencing treatment. Damaged components must not be used and must be replaced.

sCAUTION: For device transport, always keeps the pull handle in hand during transport and ensure stable platform before releasing.

sWARNING: Use for intended purposes only. Failure to observe the operating instructions may result in the patient or user suffering serious injury or the product being damaged, possibly beyond repair. Before using this product, make sure that you have studied and understood the operating instructions.

sWARNING: For use by qualified and trained personnel only.

sWARNING: Do not install where there is a risk of an explosion. The Mobile Dental System is not intended for operation in the presence of flammable anesthetics or gases.

sWARNING: Always operate a high-speed handpiece with water coolant. Operating a high-speed handpiece without water coolant can cause thermal injury to the patient.

sCAUTION: Observe local regulations concerning disposal of amalgam waste.

sWARNING: Never operate unit or work on patients when the top lid is open.

sWARNING: Do not use this device for dental implant procedures.

sCAUTION: Do not run saline solutions through the water sys- tem—saline will corrode the water filters.

sWARNING: Do not position the AMC 25 so that the power cord is inaccessible to unplug during normal use.

sWARNING: No modification of this equipment is allowed.

sCAUTION: Dispose of all medical waste products, residues, equipment and etc. in accordance with local Regulations.

sCAUTION: All repairs are to be performed by Authorized Repair Personnel only. Aseptico offers servicing of equipment that is out of warranty and this is highly recommended to ensure optimal performance and product life. Circuit diagrams, parts list and requested relevant servicing information will be provided upon request.

sCAUTION: Do not use CaviCide™ cleaner on the AMC 25.

OPTIONAL EQUIPMENT SAFETY PRECAUTIONS:

sWARNING: CONTRAINDICATIONS — Ultrasonic oscillations emitted by the ultrasonic scaler may prevent the proper function of cardiac pacemakers. Therefore, Aseptico recommends that patients with a cardiac pacemaker should not be treated with the ultrasonic scaler component of the AMC 25 Cart.

sWARNING: Ultrasonic scaler instrument tips oscillate at high frequency and can fracture during operation. To help prevent the tips from fracturing and possibly injuring the patient, always follow the scaler manufacturer’s operating instructions and recommended ultrasonic power settings.

sWARNING: Do not use the ultrasonic scaler dry. If used dry, the instrument tip will heat immediately. This may cause thermal injury to the tooth. Ensure that adequate liquid coolant is always available.

sCAUTION: Never use the ultrasonic scaler on metal or porcelain restorations. The high frequency ultrasonic oscillations may loosen the restoration.

sWARNING: Avoid looking directly into the curing light. Protect patient’s eyes with darkened eye-wear when using the curing light probe.

sCAUTION: The lens for the electric motor LED is soft and can be damaged. If lens needs to be cleaned, use a lint-free swab and isopropyl alcohol - do not use other solvents as they might adversely react with the LED assembly.

sCAUTION: The AEU-5000 electric motor is not recommended for use with endodontic files that have torque limit specifications of less than 1.39 oz-in (100 g-cm).

sWARNING: Do not exceed 130.5 psi (9 bar) on external air pressure entering the system.

sWARNING: Do not exceed 100 psi (6.9 bar) on the external regulator.

sWARNING: Do not exceed 14 in Hg (35.6 cm Hg) on external vacuum pressure.

sWARNING: Do not exceed 46.4 psi (3.2 bar) on external water pressure entering the system.

2

Congratulations!	AMC-25
		TABLE OF CONTENTS

Your new Aseptico AMC 25 Dental System is the finest mobile dental system available. The system provides an array of standard and optional dental equipment features and functions designed to serve a wide range of dental applications—all conveniently packaged into a single self-contained transportable cart.

This system is engineered to provide many years of reliable service. Please read the instructions provided in this manual to receive the best and longest service from your Aseptico equipment. Separate manuals may be provided to cover the operation and maintenance of other accessories for your unit.

NOTE: Shaded paragraphs throughout this manual indicate optional equipment and features.

P.O. Box 1548 • Woodinville, WA 98072

8333 216th Street S.E. • Woodinville, WA 98072 USA International [phone] • Toll Free [phone]

STANDARD FEATURES	4
PACKAGE CONTENTS	4
INTENDED MEDICAL INDICATION	5
FRONT VIEW	6
SIDE VIEW	7
TOP VIEW	8
REAR VIEW	9
SETTING UP THE UNIT	10
SYSTEM OPERATION	14
MAINTENANCE AND STERILIZATION	17
TROUBLESHOOTING GUIDE	20
MESSAGES	21
REPLACEMENT PARTS LIST	21
SYMBOL DEFINITIONS	22
SPECIFICATIONS	22
WARRANTY	23
PACKING INSTRUCTIONS	24
NOTES	25

3

AMC-25

STANDARD FEATURES

•Automatic handpiece controls for 3 pneumatic handpieces

•Each pneumatic handpiece provides individually controlled water and coolant air

•3-way air/water syringe with a self contained water system

•High Volume (HVE) and low volume vacuum lines with adjustable suction valves and a solids trap

•1/2 HP compressor pump and 1/2 HP vacuum pump with venturi boost operating independently

•Aluminum tank for rust-free air supply

•Rotating arms for positioning of tubing on the front of the cart

•Dual voltage system

OPTIONAL FEATURES

•Integrated electric motor with control panel. Electric handpiece provides individually controlled water and coolant air

•Ultrasonic scaler

•Curing light

•Fiber-optic illumination for handpieces

•Amalgam separator

•External vacuum/air/water hospital connections

PACKAGE CONTENTS

•Self Contained Mobile Cart

•HVE and Saliva Ejector Hoses with Valves

•TA-90D 3-Way Air/Water Syringe with Tip

•Two 1-Liter Water Bottles, PN 730631-01

•AA-43W Wet/Dry Foot Control

•Power Cord – 120V Hospital Grade, PN 840049

•Waste Hose Assembly, PN 330673

•AA-60FL Waste Flush Hose

HANDPIECES PURCHASED SEPARATELY

OPTIONAL EQUIPMENT

•AEU-5000 Remote Mount (AMC 25) Kit, PN 330674

•AA-19LED-25CK5 Fiber-Optic 5-Hole Handpiece Illumination Kit

•AA-25CLM-CK Curing Light w/Module Kit

•ASC-10-25CKL Ultrasonic Scaler with 3 Tips

•AA-20CL-CK Rapid Cure LED Visible Curing Light

•AA-20AMAL-CK Amalgam Separator and Bypass Filter

•Portable Case for Transporting Mobile Cart, PN 410195

•AA-25HK Hospital Kit (external vacuum, air, water connections)

•AA-20A Auxiliary Arm and Accessory Tray

•AA-19A-25CK Fiber Optic 6 Pin Kit

4

AMC-25

INTENDED MEDICAL INDICATION

The AMC 25 is a mobile self-contained dental system that is used for endodontic and general dentistry applications.

USER PROFILE

Users include Dentists, Dental assistants and Dental Hygienists. The device is restricted for sale by or on the order of a dentist.

PATIENT POPULATION

The AMC 25 intended patient population includes infant to adult of any gender in general good health based on dentist’s judgement.

INTENDED BODY OR TISSUE PARTS

Patient’s treatment area is inside the patient’s mouth (primarily teeth and gums) for endodontic and general dentistry applications. The following may come into contact during procedures:

•Air / water using 3-way air water syringe during treatment

•Vacuum line is placed inside of patient mouth contacting soft tissues, cheeks, gums and tongue for evacuating fluids

•Handpieces are sold separately and not considered part of standard AMC-25 package. Handpieces are equipment that hold burs, diamonds, finishing discs or similar items used in making or finishing filings, crowns, bridges, dentures or like dental treatment in teeth. Sealants is material applied to teeth as protection against cavities.

•Polishing and finishing strips and discs are strips and discs used to polish and finish different types of composite material placed on patient’s teeth.

•Hand instruments used during dental treatment. Rotary cutting carbides used in making of crowns, bridges, dentures or like dental treatment.

•Ultrasonic scaler vibrates at low frequency to clean teeth and comes into contact with teeth and gums. Ultrasonic scaler inserts are not sharp—there are no cutting edges

•Curing light – Used for curing resins and comes into contact with teeth and gums. Typically, in blue light spectrum.

The following items are not supplied with the system but may be used and purchased separately and contact the patient:

•Cleanser/ mouthwash: used to prepare the mouth area for procedure

•Alcohol: used to prepare the skin for topical anesthetic

•Anesthetic: used to prepare affected teeth / gums for the procedure

•Dry gauze

User’s fingers/hands will interact with:

•Packaging: opening replacement treatment tips

•Handpiece: administering/adjusting treatment, acknowledging system messages, and changing treatment tips

•Treatment tip: changing tips

•Display/touchscreen: selecting/adjusting items from user interface, and/or cleaning display/touchscreen

•Power cable: plugging into system and outlet.

•Footswitch: picking it up to move/reposition it or clean it.

•On/Off switch: turning the system on and off

CONDITIONS OF USE

The AMC-25 is not provided sterile. Clean, disinfect, and sterilize new or repaired hand¬pieces and instruments before first use and between each patient use. Only use sterilized handpieces and instruments during treatment.

Air / Water Syringe are available as disposable or reusable. Reusable tips are to be sterilized before use.

General: Single office or outpatient clinic.

•Normal Usage: Temperature range: 10°C to 40°C and relative humidity range: 10-95% non-condensing

•Shipping Conditions: Temperature range: -40-71ºC and relative humidity range: 1095% (non-condensing)

•Mobility – System may be transported room to room in the same facility but is not recommended to be moved location to location.

OPERATING PRINCIPLES

•Electric and pneumatic Handpiece using variable high-speed rotary attachments for grinding, buffing, drilling and sealant applications.

•Air water syringe uses compressor to generate positive pressure for delivery of air and water.

•Vacuum uses negative pressure from compressor to generate vacuum

•Ultrasonic scaler uses piezo effect to create low frequency vibration of cleaning tips to clean teeth

PHYSICAL AND PERFORMANCE CHARACTERISTICS

Operating voltages are specified in Specifications section of this manual.

EXPECTED SERVICE LIFE

The expected service life is seven years from the date of first use.

5

AMC-25

Optional Equipment (shaded)

VIEW FRONT

Scaler Control Knob

Hinged Lid

Electric Motor Control Panel

Instrument Holders

Handpiece Pressure Gauge

Electric Motor Connector

Auxiliary Water Connection

Auxiliary Air Connection

Bulkhead Connectors

Foot Control with Water Valve

6

Water Bottle Caps

Water Supply Bottles

AMC-25

Optional Equipment (shaded)

Accessory Tray

Control Panel:

•Water Coolant

•Bottle Selector

• Bottle Pressure Release

•Flush Toggle

•Air Coolant

VIEW SIDE

Rear Caster with Brake

7

AMC-25

Optional Equipment (shaded)

Fiber Optics / Curing Light Module

External Pressure Gauge

External Pressure Regulator

Amalgam Separator / Bypass Filter

Syringe Shipping Fasteners

Retaining

Screw

Scaler Shipping Fasteners

VIEW TOP

Use Only

Power Supply

Provided

Scaler Module

Internal Pressure Gauge					Adjustment Block
			Syringe Flow
Air Flow Adjustment Block	Internal Pressure Regulator

Instrument Holder Arms

8

AMC-25

Optional Equipment (shaded)

External Water Connection

External Air Connection

Waste Hose Hanger

Waste Compartment Latch

110V Outlets

220V Outlets

Waste Pump Switch

Waste Hose Quick Disconnect

Air Tank Purge Valve

Air Tank Drain

External Vacuum Connection

Exhaust Air

Input Air Filter Cover

Voltage Selector

Pressure Circuit Breaker

Vacuum Circuit Breaker

Main Power/Circuit Breaker

Power Input Socket

Isolation Transformer Breaker

Waste Pump Breaker

Waste Tank Connector

Bypass

Filter

Waste Tank with

Solids Collector

Amalgam Separator

Waste Flow Valve

VIEW REAR

9