Midmark M3 UltraFast User Manual

TP202 Rev. A
M3 UltraFast
®
Automatic Sterilizer
For Models:
M3 (-001 thru -004)
User Guide
2
TP202 Rev. A
003-1658-00 © Midmark Corporation 2015
Serial Number VXXXXXX
VXXXXXX
VXXXXXX
Model / Serial Number:
Date of Purchase:
Midmark Authorized Service Company:
Dealer:
Product Information
Model / Serial Number Location
3
TP202 Rev. A
003-1658-00 © Midmark Corporation 2015
Table of Contents
Important Information
Component Location ........................................4
Safety Instructions ...........................................5
Intended Use....................................................5
Electromagnetic Interference ...........................5
Safety Symbols ................................................6
Transportation / Storage Conditions ................6
Operating Environment ....................................7
Electrical Ratings / Requirements ....................7
Sterilization Monitoring Guidelines...................8
Installation
Location Requirements ....................................9
Power Cord Connection .................................10
External Condensing Tank
Connections ................................................... 11
External Condensing Tank
Draining Procedures ......................................13
Operation
Quick Reference ............................................14
Power Switch .................................................15
Filling the Reservoir .......................................15
Qualication Testing .......................................16
Loading the Tray ............................................16
Cycle Selection ..............................................20
Post Sterilization Processing .........................22
‘Additional Heat’ Cycle ..................................22
Adjusting the Dry Time ...................................23
Accessories
Accessory Chart.............................................23
Maintenance
Maintenance Messages .................................23
Daily Care ......................................................24
Periodic Maintenance ....................................25
Monthly Maintenance .....................................27
Extended Use Maintenance ...........................28
Printer (optional)
Printer Harness Connection ...........................29
Printer Readout ..............................................30
Paper Roll Installation ....................................31
Printer Ribbon Cartridge Replacement ..........32
Troubleshooting
Error Codes....................................................33
User Diagnostic Mode....................................34
Calling for Service ..........................................35
Specications
Specication Information................................36
Water Purity Specications ............................37
Warranty Information
Scope of Warranty .........................................38
4
TP202 Rev. A
003-1658-00 © Midmark Corporation 2015
Important Information
Component Location
Distilled
Water
0
Power Switch
(ON / OFF)
Reservoir
Fill Port
Display Panel
Drain Coupling
Drain Hose
Drain Hose
(storage location)
Door / Tray
Door
Gasket
External Condensing Tank
Operation & Care Sheet w/ User Training CD
5
TP202 Rev. A
003-1658-00 © Midmark Corporation 2015
Intended Use
The M3 UltraFast® Automatic Sterilizer can be used in medical, dental, and veterinary ofces, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization. Refer to ‘Loading the Tray’ & ‘Cycle Parameters’ in this manual for detailed information.
Electromagnetic Interference
The Midmark M3 is designed and built to minimize electromagnetic interference with other devices. However, if interference is noticed between another device and this sterilizer:
Remove interfering device from room
Plug sterilizer into a dedicated circuit
Increase separation between sterilizer and interfering device
Contact Midmark if interference persists
Safety Instructions
The primary concern of Midmark is that this equipment is operated and maintained with the safety of the patient and staff in mind. To assure safe and reliable operation:
• Read and understand this manual before attempting to install or operate the sterilizer.
• Assure that the appropriate personnel are informed on the contents of this manual. (This is the responsibility of the purchaser).
• Assure that this manual is located near the sterilizer, or if possible, permanently afxed
to the sterilizer.
6
TP202 Rev. A
003-1658-00 © Midmark Corporation 2015
Safety Symbols
Equipment Alert
Indicates a potentially hazardous situation which could result in equipment damage.
WARNING
Indicates a potentially hazardous situation which could result in serious injury.
DANGER
Indicates an imminently hazardous situation which will result in serious or fatal injury. This symbol is used only in the most extreme conditions.
Caution
Indicates a potentially hazardous situation which may result in minor or moderate injury. It may also be used to alert against unsafe practices
Note
Amplifies a procedure, practice, or condition.
Transportation / Storage Conditions
Ambient Temperature Range: .......... -22°F to +140°F (-30°C to +60°C)
Relative Humidity:............................ 10% to 90% (non-condensing)
Atmospheric Pressure: .................... 49.6 kPa to 106.4 kPa (7.2 psi to 15.4 psi)
Equipment Alert
All water must be removed from the reservoir before transporting or storing at +32°F (0°C) or below.
Shipping Symbols
Proper shipping orientation
Fragile
Caution Shipping Damage
Keep dry
2 Person Lift
7
TP202 Rev. A
003-1658-00 © Midmark Corporation 2015
Operating Environment
Equipment Alert
Unit should be allowed to reach room temperature before operating. Failure to do so could result in damage.
Ambient Temperature Range: .......... +68°F to 104°F (+20°C to 40°C)
Relative Humidity:............................ less than 80% (non-condensing)
(Pollution Degree 2, in accordance to IEC664)
Normal Operating Altitude: ..............less than 9842 ft. (3000 m) above sea level
• Approved for indoor use only
• Environment should be relatively dust-free
Electrical Ratings / Requirements
Note
To ensure unit is properly grounded, it must be connected to a matching grounded, dedicated, correctly polarized receptacle.
WARNING
Use 104-127 VAC, 50/60 HZ alternating current only for 115 VAC rated models and 207-253, 50/60 HZ alternating current only for 230 VAC rated models. Failure to do
so could result in electrical shock to personnel and will result in damage to sterilizer.
M3 (115V model): ...........................115 VAC, 50/60 Hz, 12 amp
Max. Power Consumption: ............1400 Watts
Requires*: .......................................Dedicated supply circuit rated at 120 VAC, 50/60 Hz, 12 amp
M3 (230V model): ...........................230 VAC, 50/60 Hz, 6 amp
Max. Power Consumption: ............1400 Watts
Requires*: .......................................Dedicated supply circuit rated at 230 VAC, 50/60 Hz, 6 amp
*Power source must have over voltage limits less than 1500 watts from mains to ground.
(Installation Category II in accordance to IEC 664)
8
TP202 Rev. A
003-1658-00 © Midmark Corporation 2015
Sterilization Monitoring Guidelines
Note
The information below is provided for reference only. Contact appropriate state / local agencies for specific sterilization guidelines for your office. Additional information on infection control is available from the Centers for Disease Control and Prevention (CDC), Organization for Safety and Asepsis Procedures (OSAP), and the American Dental Association (ADA).
Physical Monitors
Temperature and pressure measuring devices can help detect sterilizer malfunctions. The sterilizer’s control system aborts the cycle and displays a message if physical conditions go outside established limits. The optional printer can be used to create a record of each load’s actual cycle time, temperature, and pressure.
Note
Use only FDA cleared chemical & biological indicators designed for steam sterilization that are compatible with the particular sterilization cycle temperature and exposure time being monitored. Use sterility monitors with each sterilization load. If a sterilization cycle is terminated prematurely, reprocess instruments to ensure sterility of the load. Process the load according to your regular practice, placing indicators near the handle side of tray. Follow manufacturer’s instructions for proper disposal of used indicators.
Chemical Indicators
Chemical indicators are designed to verify that conditions in the sterilizer chamber were adequate to achieve sterilization. They do not validate that a processed item is sterile. If a chemical indicator shows a failure, items in that load are considered non-sterile. Potential causes for sterilization failures include:
improper cleaning, packing, loading, or a sterilizer malfunction. Determine the cause of any sterilization failure, and remedy the situation before running the next cycle. Only FDA cleared chemical indicators labeled for use with the nontraditional steam sterilization cycle parameters, e.g. temperature and exposure
time, of the M3 Sterilizer should be used for monitoring the three M3 UltraFast® cycles. Follow the chemical
indicator’s instructions for proper storage, use, interpretation, and disposal.
Biological Indicators
Biological indicators are microbiological devices designed to accompany items being sterilized to monitor adequacy of the sterilization process. If a biological indicator shows a failure, items in that load are considered non-sterile. Potential causes for sterilization failures include: improper cleaning, packing, loading, or a sterilizer malfunction. Determine the cause of any sterilization failure, and remedy the situation before running the next cycle. Only FDA cleared biological indicators labeled for use with the nontraditional steam sterilization cycle parameters, e.g. temperature and exposure time, of the M3 Sterilizer
should be used for monitoring the three M3 UltraFast® cycles. Follow the biological indicator’s instructions
for proper storage, use, interpretation, and disposal.
9
TP202 Rev. A
003-1658-00 © Midmark Corporation 2015
Installation
Location Requirements
(Allow clearance on both sides)
2"
(5 cm)
4"
(10 cm)
2"
(5 cm)
2"
(5 cm)
24"
(61 cm)
Support Surface
Clearance
Requirements
4"
(10 cm)
22"
(56 cm
)
Support Surface
• Material should be water-resistant material
(Ex. laminate, stainless steel, stone, etc.)
• Surface must be level to ensure proper operation.
• Surface should meet minimum dimensions listed below:
Dimensions
Depth (front to back) .................24 in. (61 cm)
Width (side to side) ...................22 in. (56 cm)
Clearance Requirements
To ensure proper air circulation, and to allow access to the reservoir ll port and drain coupling, adhere to the minimum clearance requirements listed below.
Clearance Requirements
Back of Unit - Back Wall .................................................4 in. (10 cm)
Front Sterilizer Feet - Front of Support Surface .............4 in. (10 cm)
Side of Unit - Side Wall ...................................................2 in. (5 cm) each side
Distance Above Unit* ......................................................2 in (5 cm)*
* The minimum clearance for proper air circulation is listed.
However, be sure to allow access to the reservoir ll port located on top of the sterilizer.
10
TP202 Rev. A
003-1658-00 © Midmark Corporation 2015
Power Cord Connection
0
0
WARNING
Check the serial number label on back panel of sterilizer to verify voltage rating for the unit. Failure to connect sterilizer to an appropriate power supply could result in damage to the unit, and electrical shock to personnel.
Voltage
Rating
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.
Equipment Alert
For optimal performance, allow sterilizer to reach room temperature before operating.
To connect the power cord...
A) Plug power cord into receptacle on back of sterilizer. B) Plug power cord into a properly polarized and grounded receptacle rated for a minimum of 15 amps. A dedicated circuit only used for the sterilizer is recommended.
11
TP202 Rev. A
003-1658-00 © Midmark Corporation 2015
0
0
External Condensing Tank Connections
Equipment Alert
The tank hose must be properly connected (and not kinked). Improper connection will cause water / steam leaks or a sterilizer
malfunction if water flow to the tank is restricted.
Note
External Condensing Tank is not needed if M3 UltraFast® is connected to the VistaCool direct-to-drain thermal reduction system.
To connect the condensing tank...
A) If connected, disconnect sterilizer power cord. B) Push tank hose into compression fitting on lid. Tighten nut. (If step B is difficult - see NOTE) C) Connect tank hose to back of sterilizer. D) Fill condensing tank with tap water to minimum water level indicator line. E) Secure the lid on the condensing tank by aligning the tabs and rotate lid clockwise to secure.
Note
If tubing is difficult to install...
A) Remove compression nut & two ferrules. B) Install nut and ferrules onto tank hose as shown. (Large & small ferrules must be positioned as shown) C) Insert hose into tank fitting, then tighten nut.
Power Cord
Compression
Fitting
Tank Hose
Min. Water Level
Indicator Line
Ferrule (small)
Ferrule
(large)
Nut
12
TP202 Rev. A
003-1658-00 © Midmark Corporation 2015
0
0
External Condensing Tank Connections - continued
Note
Clearance...
Maintain a minimum of 6 inch clearance above the condensing tank for proper steam ventilation. If enclosed in a cabinet the support surface and surrounding surfaces, should be protected with a water resistant material (e.g. plastic, laminate, stainless steel, etc.). If enclosed in a cabinet, it is recommended that the door be vented to avoid heat, moisture build up and potential damage to the inside of cabinet.
To connect the condensing tank - continued...
F) Place tank on a level surface, preferably below the sterilizer but in no case should it be higher than the sterilizer support surface. G) Connect sensor plug. H) Connect sterilizer power cord.
Power Cord
Sensor Plug
Loading...
+ 28 hidden pages