Welch Allyn Kreativ Mach 5.0 User manual

Mach 5.0 and Mach 5.0 PLUS
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Air Abrasion Units
Instructions for Use
Please read this manual thoroughly
prior to first use
CAUTION: This device must only be
purchased by, or sold to, a licensed dentist.
Manufactured by
Kreativ, Inc. (USA) 7360 Carroll Road San Diego, CA 92121
Copyright © 1999, Kreativ, Inc. All rights reserved. No part of this manual may be
reproduced without written permission from Kreativ, Inc.
European Authorized Representative
Welch Allyn LTD.
Navan, Co. Meath
Republic of Ireland
Ph: 353-46-79060
990008 Rev. H

TABLE OF CONTENTS

1. INTRODUCTION AND GENERAL INFORMATION 4 SPECIFICATIONS 6
2. SAFETY 8 WARNINGS 8 CAUTIONS 8 SAFETY MARKINGS ON LABELS 10
3. CONTROLS AND CONNECTORS 11 ITEM DESCRIPTIONS 11 CONTROL PANEL 12 DRAWINGS OF CONTROLS 13 FUNCTIONAL DESCRIPTION 15
4. UNPACKING AND SETUP 17 GENERAL INFORMATION 17 UNPACKING AND SETUP 17 AIR SUPPLY REQUIREMENTS (M ACH 5.0 ONLY) 18 ELECTRICAL REQUIREMENTS 18 MACH 5.0/D ENTAL CHAIR PNEUMATIC INTEGRATION 18
5. INSTALLATION AND UNIT CHECKOUT 20 PRE -INSTALLATION REQUIREMENTS 20 UNIT CHECKOUT 20 FILLING THE MIXTURE CHAMBER 21 OPERATIONAL CHECKOUT 22 FOOTSWITCH OPERATION 22 UNIT SHUTDOWN 22 MIXING CHAMBER POWDER UNLOADING 22
6. STERILIZATION PROCEDURES 24 HANDPIECE 24 HANDPIECE CRADLE 24 ACCESSORIES 24 POWDER 25
7. ROUTINE MAINTENANCE 26 DAILY REQUIREMENTS 26 WEEKLY REQUIREMENTS 26 MONTHLY REQUIREMENTS 27
8. TROUBLESHOOTING 28 TROUBLESHOOTING TIPS 28
Page 2 990008 Rev. H
ERROR CODES 30
9. HANDPIECES/NOZZLES AND ABRASIVES 31 STANDARD NOZZLES 31 SUPERSONIC TURBO (SST) TIPPED HANDPIECE ASSEMBLIES 31 ABRASIVES, GAMMAPURE
®
(GAMMA TREATED) 31
ORDERING INFORMATION 32
10. RECYCLING 34 RECYCLING INSTRUCTIONS FOR DEVICE, ACCESSORIES AND PACKAGING 34 ENVIRONMENTALLY RELEVANT MATERIAL 34
11. WARRANTY, RETURNS AND ADJUSTMENTS 36 RETURNS AND ADJUSTMENTS 36 LIMITED WARRANTY 36 STORAGE AND SHIPMENT 37
Page 3 990008 Rev. H

1. Introduction and General Information

1

Introduction

The Kreativ Mach 5.0 and Mach 5.0 PLUS systems are compact, highly reliable, state­of-the-art instruments designed for Air Abrasive MicroDentistry. They are designed as a means of removing tooth structure and other materials to prepare teeth for restoration, and as an adjunct to the high speed dental handpiece and bur. These instruments were developed after extensive consultation with dentists in order to provide the optimum performance, taking into consideration patient comfort and the time constraints faced by today’s 21st Century dental office.
Chapter
Note: Clinical use of the Kreativ Mach 5.0 and Mach 5.0 PLUS air abrasion systems for procedures not included or suggested in this instruction guide is not advised. Similarly, the Kreativ Mach 5.0 and Mach 5.0 PLUS systems should be only used by dental professionals who have practiced on extracted teeth and who are thoroughly familiar with this manual.

Purpose of this Manual

This manual should be thoroughly studied before installing and using the equipment. Please call your nearest authorized Welch Allyn / Kreativ service representative if you need additional information regarding installation, operation, or service of the instrument.
Information essential to the installation, operation, and routine maintenance of the Mach
5.0 and the Mach 5.0 PLUS devices manufactured by Kreativ, Inc., is included in this manual. The instructions are written specifically for personnel who have been trained in restorative and preventive dentistry.
A full selection of abrasive powders and nozzle sizes are available from your nearest Welch Allyn / Kreativ sales representative. See the listing of supplies in Chapter 8.
All serviced components, such as control valves and hose connections, can be easily accessed through the side doors of the instrument. A footswitch is provided to start the powder flow. The instrument features a mixing chamber which can be quickly unloaded in order to facilitate service, changing abrasive powders, or cleanup of the unit after use.
Page 4 990008 Rev. H

General Information and Features

The Kreativ Mach 5.0 and Mach 5.0 PLUS systems are designed to provide controlled flow of an abrasive powder and air mixture through a very precise nozzle. Applications include amalgam removal, cutting, abrading, deburring, peening and etching of tooth structures and other materials. Features of the Mach 5.0 and the Mach 5.0 PLUS air abrasion systems include:

Operating Modes

PowerPulse™ - optimized to remove amalgam
MicroPulse™ - for removal of tooth structure
Continuous - for microetching procedures

Remote Control

Continuously Variable levels controlled by the user:
Particle Energy (minimum is 30, maximum is 120), see Table 1 for psi-
to-kPa conversion in Chapter 3
Beam Intensity (minimum powder is 0, maximum is powder 10)
Remote Control module can be attached to dental units via an extension cable
Easy to read LED display
Visual and audible indicators
Diagnostic/maintenance reminders
Replace pinch tube in Pinch Valve #1
Service Needed
Powder Low
Replace pinch tube in Pinch Valve #2
Empty Exhaust Bottle
Input Error
Handpiece holder (bracket with sensor)

Interfaces with Dental Unit

Remote Control offers movement of the control panel to the location of the
dentist’s choice, usually near other handpieces
Keeps all controls at your fingertips
Seamless integration of air abrasion with traditional dental instruments
Page 5 990008 Rev. H

Full Diagnostic

At start-up
Continuous monitoring

Additional Features

Quickly detachable handpiece for easy sterilization
Double doors for simplifying preventive maintenance
Exhaust bottle container
Easy pinch tube replacement
Easy access to powder canister
Accessory drawer for nozzles, handpieces, etc.
Full range of operation from 30 psi to 120 psi
Convenient handles
Mobility
Wide range of nozzles in sizes/angles and cutting capabilities
Locked doors to prevent unauthorized access

Specifications

Power Requirements: Domestic
Air Requirements: Mach 5.0, 80 to125 psi (550 to 860 kPa) with
Mach 5.0 100-127 V~, 60 Hz, 400 mA Mach 5.0 PLUS 100-127 V~, 60 Hz, 6.5 A
International Mach 5.0 220-240 V~, 50 Hz, 170 mA Mach 5.0 PLUS 220-240 V~, 50 Hz, 3.5 A
NOTE: Verify unit has correct voltage for your application.
at least 1.5 cfm (42.5 l/min) recommended; the supply pressure must be at least 5 psi (35 kPa) greater than the selected operating pressure.
The Mach 5.0 PLUS incorporates a built-in compressor which has an automatic thermal
Page 6 990008 Rev. H
cut-out if the head reaches approx. 212° F (100° C), and a thermal cut-in when the temperature drops to 140° F (60° C).
Approximate Size: Mach 5.0, 12” x 18” x 8.5”
(30.4 x 45.7 x 21.5 cm)
Mach 5.0 PLUS, 25” x 18” x 8.5” (63.5 x 45.7 x 21.5 cm)
Approximate Weight: Mach 5.0, 30 lbs. (15.9 kg)
Mach 5.0 PLUS, 85 lbs. (38.6 kg)
Environment Limitations: Operational Requirements: Temperature: 50° F to 95° F (+10° C to 35° C)
Humidity: 30 % to 75 %
Atmospheric pressure range: 10.15 psia ( 70 kPa) to
Transport and Storage Requirements: Temperature: 14° F to 122° F (-10° C to 50° C) Humidity: 10 % to 90 % Atmospheric pressure range: 7.25 psia ( 50 kPa)
15.37 psia (106 kPa)
to 15.37 psia (106 kPa)
Equipment Classification: The Mach 5.0 and Mach 5.0 PLUS systems are Class I devices requiring an electrical earth ground. These devices are classified as ordinary with regard to protection against water ingress.
Electrical Fuses: Littelfuse, SlowBlow
Model Fuse Mfr Mfr P/N Kreativ P/N Fuse Rating
Mach 5 115V Littelfuse Type 326-001 600089 1A, 250Vac Mach 5+ 115V Littelfuse Type 326-010 600071 10A, 250Vac
or Bussmann Type MDA-10 600071 10A, 250Vac Mach 5 230V Littelfuse Type 218-01.6 600096 1.6A, 250Vac Mach 5+ 230V Littelfuse Type 218-06.3 600112 6.3A, 250Vac
UL Canadian Classification Marking:
Air Abrasive Micro Dentistry Device, Model 9000-XX
(where XX can be any alphanumeric character)
WITH RESPECT TO ELECTRIC SHOCK, FIRE, MECHANICAL
Page 7 990008 Rev. H

2. Safety

2
The Kreativ Mach 5.0 and Mach 5.0 PLUS systems are designed for use only by and on the order of a dentist.

Warnings

Always wear protective eye equipment in order to avoid corneal abrasion or irritation if particles are deflected into the eye. This applies to the dentist, staff, and patient.
A rubber dam is recommended in order to avoid injury to gingiva or other soft tissue, and for interproximal preparations to protect adjacent tooth surfaces.
AND OTHER SPECIFIED HAZARDS ONLY
IN ACCORDANCE WITH CAN/CSA C22.2 NO. 601.1
21ZJ
Chapter
Never direct the handpiece to an open pulp chamber or at pulpal exposures. Also never place the handpiece in direct contact with the gingiva when the air pressure is activated. While the abrasive stream will not cut the gingival tissue, it may irritate it.
All Kreativ Mach 5.0 and Mach 5.0 PLUS accessories which come into contact with the patient should be sterilized prior to each use. Always disinfect the handpiece cradle in the remote control unit before each patient use.
Always use your high volume evacuation system when using the handpiece of the Kreativ Mach 5.0 or Mach 5.0 PLUS. Have the dental assistant place the high volume evacuation system in close proximity to the operative site.
Make sure that the Kreativ Mach 5.0 and Mach 5.0 PLUS systems are connected to a properly grounded electrical outlet.
Always replace fuses with fuses of the proper rating, as indicated in the Chapter 1.

Cautions

For dental cleaning (prophylaxis) procedures, be absolutely sure that the chamber and hose have been completely cleared of all abrasive powders and use only bicarbonate in the chamber.
Page 8 990008 Rev. H
The handpiece should be directed precisely at surfaces and tooth structures which are to be modified or removed. The nozzle tip should be placed a few millimeters from the tooth and angled toward the area to be removed or modified. Unlike the high speed handpiece, the Mach 5.0 nozzle cuts only directly from the end; there is no side cutting.
Do not attempt to service the unit beyond those items described in the maintenance section. Call your nearest Welch Allyn / Kreativ service representative for instructions.
Practice on extracted teeth prior to utilizing the Mach 5.0 and Mach 5.0 PLUS on patients. Begin with the 27.5 micron aluminum oxide powder. Use only short bursts, carefully monitoring your progress. Most users prefer the 27.5 micron powder at a Particle Energy setting of 50 to 80 psi due to improved patient acceptance.
Do not substitute non-Kreativ, Inc., materials or accessories. Use of materials or accessories supplied by other manufacturers may result in damage to the unit and will void the factory warranty.
Use only clean dry air. Make sure that your air compressor system utilizes air dryer filter systems and that they are fully operational. Any moisture or oil in the air supply will adversely affect the performance of your Mach 5.0 or Mach 5.0 PLUS.
When using the Mach 5.0, check to be sure that your air system produces at least the minimum pressure and flow rate indicated in the Air Requirements section of the Specifications in Chapter 1.
Sound clinical judgment, good common sense and proper training are essential to the successful use of the unit in order to provide safe and efficient patient care.
Always follow “standard of care” protocols in performing dental operative procedures.
The handle on the top of the Mach 5.0 PLUS units is intended to be used to pull the units and is not meant for picking up the units.
Caution: Connecting the instrument’s input air supply line to a water outlet will lead to damage to the instrument which is not covered under the limited warranty. Repairs for such damage are at the customer’s expense.
Page 9 990008 Rev. H

Safety Markings on Labels

Alternating current
Protective earth (ground)
Attention, consult accompanying documents
Off (power: disconnection from the mains)
On (power: connection to the mains)
Type B equipment (defines the degree of protection against electrical shock)
Page 10 990008 Rev. H

3. Controls and Connectors

3
The diagrams on the following pages illustrate the external controls, indicators, and connectors for the Kreativ Mach 5.0 and Mach 5.0 PLUS instruments.
In both the Mach 5.0 and the Mach 5.0 PLUS, the handpiece hose connects to a connector located under the Control Module.
The Control Module is removable from the front of the Mach 5.0 and the Mach 5.0 PLUS and can be attached to the Dental unit, as follows:
1. The Control Module is held to the front of the instrument by spring tension on the interconnecting cable. With the handpiece mounted in the cradle on top of the Control Module, the hose and the provided extension cable allow the Control Module to be remotely located up to 10 feet from the main unit. The connector to the air supply is located on the rear of the instrument.
Chapter
2. A mounting plate with clamp is supplied with the Mach 5.0 and the Mach 5.0 PLUS, to be mounted on the dental unit.
3. The Control Module will attach to the mounting plate for use at the dental unit, remotely from the main instrument.

Item Descriptions

Refer to the Drawings in this section for the following items.
(1) On/Off Power Switch: turns power on or off to the entire instrument (2) Power Cord Connector: connection point for the power cord. (3) Fuse Box: the location of the instrument fuses. Always replace with the same
type of fuse with the same rating, indicated in Chapter 1.
(4) Pneumatic Footswitch Connector: connection point for the dental chair
pneumatic footswitch.
(5) Electric Footswitch Connector: connection point for the electrical foot-switch
Page 11 990008 Rev. H
(6) Air Supply: connection point for the office air supply to the instrument (Mach
5.0 only)

Control Panel

Air Indicator: indicates the status of the air pressure as “On” or “Standby”
Mode: indicates the operating mode of the instrument as “PowerPulse,” “MicroPulse,” or “Continuous.” The power up default is PowerPulse
Beam Intensity: indicates the relative amount of abrasive powder that is being delivered to the handpiece nozzle
Warning Indicators: indicate the type of problem when operational problems occur
Particle Energy: indicates the pressure with which the abrasive powder is being delivered. Numbers in the display indicate Pounds per Square Inch (PSI).
Conversion Table of PSI to kPa
PSI kPa PSI kPa
30 210 90 620 35 240 95 655 40 275 100 690 45 310 105 725 50 345 110 760 55 380 115 795 60 415 120 825 65 450 125 860 70 485 130 895 75 515 135 930 80 550 140 965 85 585
Table 1
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