Midmark UltraClave M11 Operation Manual
Description
Page 6
Components
Overview
Page 8
Controls &
Indicators
Page 9
Calling For
Service
Page 28
Operation
Page 11
Specifications
Page 29
Operator
Maintenance
Page 20
Installation
Page 4
Important
Information
Page 2
Limited
Warranty
Page 29
Installation
& Operation
Manual
M11 UltraClave™
Steam Sterilizer
M11 UltraClave
®
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No Longer in Production:
SERVICE PARTS NO LONGER
AVAILABLE FOR THIS PRODUCT!
Owner’s Product Identification
(information that you will need to provide for servicing - key information is highlighted)
Date of Purchase Serial Number
Name of Owner / Facility / Department
Name of Authorized Dealer Telephone # of Authorized Dealer
Address of Authorized Dealer
MODEL AND SERIAL
NUMBER LOCATION
Model Number
MODEL NUMBER
SERIAL NUMBER
MA439101
CONTENTS
IMPORTANT INFORMATION ........................................................................................................ 2
Scope and Purpose of This Manual......................................................................................2
Intended Use of Product........................................................................................................ 2
Safety Instructions................................................................................................................. 2
Explanation of Safety Symbols and Notes............................................................................ 3
Transportation and Storage Conditions................................................................................. 3
INSTALLATION.............................................................................................................................. 4
Location Requirements For Sterilizer....................................................................................4
Re-Location Requirements For Sterilizer.............................................................................. 5
Electrical Requirements ........................................................................................................ 6
DESCRIPTION............................................................................................................................... 6
Operational Features............................................................................................................. 6
Mechanical Features.............................................................................................................7
Safety Features..................................................................................................................... 7
COMPONENTS OVERVIEW......................................................................................................... 8
CONTROLS & INDICATORS........................................................................................................ 9
OPERATION ................................................................................................................................ 11
Recommended Steam Sterilization Monitoring Program .................................................... 12
Sterilizer Preparation Before Operation...............................................................................12
Cleaning Instruments .......................................................................................................... 13
Guidelines For Loading Trays.............................................................................................. 14
Operation............................................................................................................................. 16
Standard Cycle Parameters................................................................................................ 19
List of Authorized Accessories............................................................................................ 19
OPERATOR MAINTENANCE ..................................................................................................... 20
Daily .................................................................................................................................... 20
Weekly................................................................................................................................. 20
Monthly................................................................................................................................ 20
Quarterly ............................................................................................................................. 23
Toubleshooting Guide.......................................................................................................... 24
Error Code Guide................................................................................................................26
CALLING FOR SERVICE............................................................................................................ 28
SPECIFICATIONS....................................................................................................................... 29
LIMITED WARRANTY................................................................................................................. 29
PRINTER INSTALLATION AND OPERATION ............................................................................ 30
Installing the Printer ............................................................................................................ 31
Operating the Printer...........................................................................................................34
Inserting the Paper Roll....................................................................................................... 34
About the Cartridge Ribbon................................................................................................. 35
Installing a New Cartridge Ribbon....................................................................................... 36
Removing the Paper Roll.....................................................................................................37
Power Up Message............................................................................................................. 37
Printer Tape Description...................................................................................................... 37
2
IMPORTANT INFORMATION
Scope and Purpose of This Manual
This manual provides complete instructions for the installation, operation, and
normal care of the M11 UltraClave™ Steam Sterilizer. It is intended that this
manual be used by all personnel operating the sterilizer or performing operator
level maintenance. No repair information is included in this manual as no repairs are authorized at the operator level.
Intended Use of Product
The M11 Ultraclave is intended to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat stable and moisture stable, reusable equipment. Dental handpieces can be
sterilized in the M11 in the Pouches cycle. This device is not recommended for
sterilization of liquids intended for direct patient contact. Refer to Standard Cycle Parameters on page 19 in this manual for detailed information.
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 safer and more
reliable operation:
• Read and understand this manual before attempting to install or operate the
sterilizer.
• Assure that 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 affixed to the sterilizer.
Important
Information
3
Important
Information
Explanation of Safety Symbols and Notes
Transportation and Storage Conditions
• Ambient Temperature Range:..... -40°C to +70°C (-40°F to 158°F)
• Relative Humidity........................ 10% to 90% (non-condensing)
• Atmospheric Pressure ................ 500hPa to 1060hPa (0.49atm to 1.05atm)
DANGER
Indicates an imminently hazardous situation which, if not
avoided, will result in death or serious injury. The DANGER
symbol is limited to the most extreme situations.
WARNING
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
CAUTION
Indicates a potentially hazardous situation which, if not avoided,
may result in minor or moderate injury . It may also be used to alert
against unsafe practices.
EQUIPMENT ALERT
Indicates an imminently or potentially hazardous situation which, if
not avoided, will or may result in serious, moderate, or minor
equipment damage.
NO TE
Amplifies an operating procedure, practice, or condition.
EQUIPMENT ALERT
The water must be drained from the unit’s reservoir before trans-
porting or storing at 0°C (32°F) or below. Also, the unit should be
allowed to reach room temperature before operating. Failure to do so could
result in damage to unit.
4
INSTALLATION
Location Requirements For Sterilizer
Adherence to the following recommendations for location of the sterilizer will
contribute to optimum performance of the unit:
Support Surface (A)
- Sterilizer must be placed on a level surf ace to ensure that
the chamber will fill correctly. Improper water level in the chamber could cause
a sterilizer malfunction.
Support Surface Material (B)
- Formica, stainless steel, or other water and heat
resistant material. Heat from bottom of sterilizer could reach 71°C (160° F) on
the support surfaces for short periods of time.
DANGER
Do not operate this sterilizer in areas where flammable anesthetics are used or stored. An explosion could occur, caus-
ing personal injury.
D
A
C
E
B
F
MA439500
Installation
5
Support Surface Depth (C) - Support surface should be approximately 533 mm
(21 in) deep. Allow at least 51 mm (2 in) clearance behind the sterilizer for air
circulation.
Distance To Side Wall (D)
- If the sterilizer is located next to side walls, there
should be no less than 51 mm (2 in) clearance between the side of the sterilizer
and the wall.
Distance Above Sterilizer (E)
- If the sterilizer is to be located beneath wall cabinets or shelves, the underside of the cabinets or shelves should be at least 584
mm (23 in) above the support surface, to provide access to the top inspection
cover and to allow for changing the printer paper roll.
Overhang (F)
- If the sterilizer is to be located beneath an overhang, the underside of the overhang should project no further than 381 mm (15 in) over the rear
of the sterilizer.
Location On Support Surface
- The front of the sterilizer should be located near
the front of the support surface so water can be easily drained from the tube into
a container.
Neighboring Materials and Equipment
- If the sterilizer will be operated in continuous cycles, locate the sterilizer where excessive emission of steam will not
damage materials or equipment in the surrounding area.
Re-Location Requirements For Sterilizer
1. Disconnect power cord from the electrical outlet and allow sterilizer to cool.
2. Drain water from reservoir or take care not to tip the sterilizer, which will
allow water to spill from reservoir.
Installation
6
Electrical Requirements
The electrical rating for the 230 VAC unit is 230 VAC, 50/60 Hz, 10 amps. The
electrical rating for the 120 VAC unit is 120 VAC, 60 Hz, 15 amps. The electrical
rating for the 100 VAC unit is 100 VAC, 50/60 Hz, 20 amps. The three-pronged
grounding plug on the sterilizer power cord must be plugged into a matching
three-pronged, grounded, isolated, correctly polarized receptacle. Check the
serial n umb er labe l on t h e b ack panel of the sterilizer to verify the voltage rating
for the unit.
DESCRIPTION
Operational Features
The M11 UltraClave™ sterilizers . . .
• will begin a sterilization program cycle when a sterilization program is
selected, the door is closed and fully latched, and the START s witch is
pressed.
• will automatically fill the chamber with water to the correct level once the
START switch is pressed.
• begin the cycle time countdown only after the proper pressure and temperature have been reached.
• automatically exhaust the steam pressure from the chamber and open the
door slightly to facilitate drying upon completion of the sterilization phase.
• automatically starts a 30 minute drying phase. Items that do not require drying may be removed any time after the sterilization phase is complete.
Sterility of unwrapped items and moist wrappings is compromised on
exposure to a non-sterile environment.
• will signal the operator that the drying phase and therefore the sterilization
WARNING
Use 220 - 240 VAC, 50/60 HZ alternating current only for 230
VAC models and 90 - 110 VAC, 50/60 HZ alternating current
only for 100 VAC models. Failure to do so could result in electrical
shock to personnel and will result in damage to sterilizer.
Do not use this sterilizer in an explosive or oxygen-enriched atmosphere. Failure to do so could result in serious personal injury or
death.
NO TE
Grounding reliability can only be achieved if this unit is connected to a matching three-pronged, grounded, isolated, correctly polarized receptacle.
Description
Installation
7
program cycle is complete by sounding five audible “beeps”. The sterilizer
may be switched to standby at this time or restarted if additional sterilization
programs are desired.
Mechanical Features
The M11UltraClave™ sterilizers . . .
• have a tray rack which can hold two small and two large trays. The tray rack
can be removed for periodic cleaning of the chamber, tray plate, tray rack,
and filter.
• have an optional printer which provides a permanent record of actual exposure times and temperatures.
• have a removable power supply cord (100 and 230 VAC units only).
• have a two gaskets in the door; a dam gasket and a door gasket which can
easily be replaced by operator in seconds.
Safety Features
The M11UltraClave™ sterilizers . . .
• have a
door stop
which prevents the door from opening fully if there is a
slight residual pressure in the chamber when the door handle is operated.
The door stop also retains the door in a partially open position during the
drying cy c le.
• have a
door closed switch
which is used to signal the sterilizer that the
door is completely closed. This switch is activated just as the door becomes
fully closed. An audible signal will sound and the “Door Ajar” light will flash if
the door is not fully closed.
•have a
water low indicator
which signals the operator if there is insufficient
water to fill the chamber to the proper level. An audible signal will sound and
the “Water Low” light will flash if the reservoir needs to be refilled with water.
• have their
chamber temperature monitored
during a cycle to prevent an
overheat condition. If chamber temperature reaches or exceeds 146°C
(295°F), power to the sterilizer is cut off.
• have a
pressure relief valve
which opens to provide backup protection to
reduce chamber pressure in the event that the chamber steam pressure
exceeds the allowable limit. Released steam is directed out of the bottom of
the unit’s cabinet. An access cover is located on the top cover for relief valve
operational checks.
• have a
fault detection circuit
which monitors all functions of the sterilizer
during a cycle. If a fault occurs during a cycle, the sterilizer monitoring circuitry will stop the cycle, sound an audible signal, and light a flashing error
lamp.
Description
Installation
8
COMPONENTS OVERVIEW
The illustration below shows the location of the sterilizer’s major components
and the chart below provides their descriptive name.
DESCRIPTION OF COMPONENTS
1. Access Cover 5. Door and Dam Gaskets
2. Reservoir Lid 6. Display / Control Pad
3. Printer (Optional) 7. Wire Tray Rack and Tray Plate
4. Level Indicator / Reservoir
Drain Tube
8. Pressure Relief Valve
1
2
3
5
6
7
4
8
MA439900
Components
Overview
9
CONTROLS & INDICATORS
The following illustrations show the location of the sterilizer’s controls and indicators and the chart on the following pages describes their function.
ON/STANDBY
ERROR
STOP
DOOR AJAR
START
WATER LOW
PACKS
COMPLETE
LIQUIDS
DRYING
POUCHES
STERILIZING
UNWRAPPED
FILLING
PRESSURE (PSI)
TEMP (°F) \ TIME (MIN : SECONDS)
2
3
1
15
14
16
13
12
11
10
4
5 6 7 8 9
17
18
20
19
MA439400
Components
Overview
Controls &
Indicators
10
Ref. Control Function
1 Temperature / Time dis-
play
alternately indicates cycle temp erature and
exposure time when a cycle is selected. During a cycle, the cycle time remaining is displayed.
2 Pressure display indicates current chamber pressure during a
cycle.
3 FILLING indicator illuminates when the chamber is being filled
with water at the beginning of a cycle.
4 STERILIZING indicator illuminates during the heat up and sterilization
phases of a cycle.
5 DRYING indicator illuminates during the drying phase of a cycle.
6 COMPLETE indicator illuminates when a cycle is complete, indicat-
ing that the sterilized goods may be removed
at this point.
7 WATER LOW indicator indicator flashes (and a beep sounds) when
the water level is too low i n t he res ervoi r t o i nitiate a cycle.
8 DOOR AJAR indicator indicator flashes (and a beep sounds) when
the door is not completely latched.
9 ERROR indicator indicator flashes (and a beep s ounds ) when a
cycle is terminated before completion.
NOTE: a corresponding error code is dis-
play ed o n the Temperature / Tim e displ a y any
time an error occurs. See Error Code Guide
for a detailed expl anation o f each error code.
10 UNWRAPPED button when pressed, selects a program cycle
designed to process unwrapped instruments
at 132°C (270°F) for 3 minutes with a 30
minute drying cycle following the steril ization
phase.
11 POUCHES button when pressed, selects a program cycle
designed to process instruments and dental
handpieces in combination paper / plastic
sterilization pouches or wrapped instruments
at 132°C (270°F) for 15 minutes with a 30
minute drying cycle following the steril ization
phase.
12 LIQUIDS button when pressed, selects a program cycle
designed to process non-volatile liquids at
121°C (250°F) for 30 minutes.
13 PACKS button when pressed, selects a program cycle
designed to process packs of instruments at
121°C (250°F) for 30 minutes with a 30
minute drying cycle following the steril ization
phase.
Controls &
Indicators
11
OPERATION
14 START button when pressed, initiates the program cycle that
has been select ed.
15 STOP button when pressed, terminates the program cycle
currently in progress.
16 ON / STANDBY button when pressed, turns the sterilizer ON or into
STANDBY mode. If the ON / STANDBY button is pressed during a cycle, the program
cycle is aborted. In Standby mode, all program buttons and indicator lights are locked
out to prevent accidental program initiation.
17 Printer The pr inter (optional equipment) can be used
on all models to provide a permanent record
of the time, temperature, and pressure
reached during a cycle. Refer to the Printer
section later in this manual for detailed information on printer features and operation.
18 Door Handle used to open or lat ch t he door . The d oor han-
dle is raised to unlatch the door and lowered
to latch the door.
19 Level Indicator / Reser-
voir Drain Tube
indicates the water le v el in the reservoir . Also ,
the tube may be detached from its clips and
used to drain the reservoir quickly and easily
into a suitable container.
20 Fill opening allows distilled or demineralized water to be
poured into the reservoir from the front of the
unit (with door in open position).
DANGER
Do not use this sterilizer in an explosive or oxygen-rich atmosphere, or where flammable anesthetics are stored. T o do so
could result in an explosion or fire.
If the sterilizer malfunctions, immediately unplug sterilizer. If the sterilizer continues to malfunction, call for service; do not attempt to repair
the sterilizer yourself.
EQUIPMENT ALERT
For optimal sterilizer performance, allow the sterilizer to reach
room temperature before operating.
Ref. Control Function
Controls &
Indicators
Operation
12
Recommended Steam Sterilization Monitoring Program
Physical monitors (temperature and pressure measuring devices) can be used
to help detect failures in sterilizer function. The sterilizer notifies the user if sterilization conditions fall outside of established limits. It is recommended that the
Printer Accessory be used to create a record of each load’s actual cycle time,
temperature, and pressure.
Process monitors, such as biological indicators and chemical indicators, should
be included in each sterilization cycle. The process monitors detect whether the
cycle parameters were delivered. Process monitors cannot establish that a processed item is actually sterile. If the monitors detect a failure, the user must determine the source of the failure. Failures could result from improper packaging,
loading, or sterilizer malfunction. Follow the process monitor manufacturer’s instructions for proper selection, storage, use, and interpretation of their devices.
Follow the appropriate agency (state dental or medical board) for sterilization
monitoring guidelines for your office. Additional information can also be obtained from CDC, AAMI, OSAP, and ADA regarding monitoring programs or other sterilization issues.
Sterilizer Preparation Before Operation
1. Locate the sterilizer and plug in its power cord in accordance with the Installation instructions contained earlier in this manual.
EQUIPMENT ALERT
Check the serial number label (1) on the back panel of the sterilizer to verify the voltage rating for the unit. Failure to do so could re-
sult in damage to the unit.
EQUIPMENT ALERT
Use only distilled or demineralized water. Normal tap water con-
tains minerals, especially chlorides, which have corrosive effects
on stainless steel. Failure to use distilled or demineralized water may cause
serious deterioration and premature failure of the stainless steel chamber
which could result in serious injury or death.
Operation
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