Midmark 003-1658-99ENG M3 Steam Sterilizer User Guide

M3 Steam Sterilizer

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For Models:

M3 (-001 thru -004) (-040 thru -042)

User Guide

Style P

TP202 20-42-FO-00014 Rev A1 C2169

003-1658-99 Rev AA6 (11/20/20)

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VXXXXXX

Product InformationProduct Information

Serial Number

Attention Canadian Users - Action Required!

ASME National Board

Number Location

Product Serial

Number Location

Thank you for purchasing an M3 Steam Sterilizer.

To comply with changes in Canadian regulatory requirements you must now provide documentation, a Manufacturer’s Data Report (MDR), to your appropriate provincial regulatory agency when purchasing and using a steam sterilizer.

To obtain the MDR from Midmark, record the sterilizer Serial Number and the ASME National Board Num- ber of your sterilizer. See the illustration below for the location of these numbers. Then, contact Midmark customer service at 1.800.MIDMARK and provide the recorded numbers.

Midmark will then complete the MDR and send it to you. Once you have the MDR, you must submit it to the appropriate provincial regulatory agency.

We apologize for any inconvenience and appreciate your assistance in helping maintain compliance to Ca- nadian regulations for sterilizers. If you have any questions or concerns, please contact 1.800.MIDMARK.

Table of Contents

Important Information

Component Location ........................................4

Safety Instructions ...........................................5

Intended Use....................................................5

Sterilization Technology

Electromagnetic Interference ...........................5

Safety Symbols ................................................6

Transportation / Storage Conditions ................7

Accessory Chart

Sterilization Monitoring Guidelines...................8

...............................5

..........................................7

Installation

Location Requirements ....................................9

Operating Environment ..................................10

Electrical Ratings / Requirements ..................10

Power Cord Connection ................................. 11

External Condensing Tank

Connections ...................................................12

External Condensing Tank

Draining Procedures ......................................14

Operation

Quick Reference ............................................15

Power Switch .................................................16

Filling the Reservoir .......................................16

Qualication Testing .......................................17

Loading the Tray ............................................17

Cycle Selection ..............................................21

Post Sterilization Processing .........................23

‘Additional Heat’ Cycle ..................................23

Adjusting the Dry Time ...................................24

Maintenance

Maintenance Messages .................................24

Daily Care ......................................................25

Periodic Maintenance ....................................26

Monthly Maintenance .....................................28

Extended Use Maintenance ...........................29

Printer (optional)

Printer Harness Connection ...........................30

Printer Readout ..............................................31

Paper Roll Installation ....................................32

Printer Ribbon Cartridge Replacement ..........33

Troubleshooting

Error Codes....................................................34

User Diagnostic Mode....................................35

Calling for Service ..........................................36

Specications

Specication Information................................37

Water Purity Specications ............................38

Warranty Information

Scope of Warranty .........................................39

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Important Information

Component Location

Distille

d

Wate

r

0

Power Switch

(ON / OFF)

Reservoir

Fill Port

Display Panel

Drain Coupling

Drain Hose

(storage location)

Door / Tray

Door

Gasket

External Condensing Tank

Operation + Care Sheet

Safety Instructions

The primary concern of Midmark is that this equipment is operated and maintained with the safety of

the patient and sta󰀨 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 a󰀩xed to the sterilizer.

Intended Use

The M3 Steam Sterilizer can be used in medical, dental and veterinary o󰀩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’ and ‘Cycle Parameters’ in this manual for detailed information.

Sterilization Technology

The Sterilization Technology used in the M3 utilizes a dynamic air removal system called Steam Flush Pressure Pulse to remove air from the chamber.

Electromagnetic Interference

The 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

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Safety Symbols

WARNING

Indicates a potentially hazardous situation which could result in serious injury.

Caution

Indicates a potentially hazardous situation which may result in minor or moderate injury. It may also be used to alert against unsafe practices

Equipment Alert

Indicates a potentially hazardous situation which could result in equipment damage.

Note

Amplifies a procedure, practice, or condition.

Shipping Symbols

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Caution Shipping Damage

Proper shipping orientation

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Keep dry

Fragile

2 Person Lift

Transportation / Storage Conditions

Equipment Alert

All water must be removed from the reservoir before transporting or storing at +32°F (0°C) or below.

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)

Accessories

Accessories Part Number Model

Printer 9A401001 M3-00x

Printer 9A401002 M3-04x Door Tray 9A402001 M3-00x Door Tray 9A686001 M3-04x

Common Service Parts/Tools Part Number

M3 Internal Filter Screen 016-1095-00

2 1/2” Paper Roll 060-0008-00

Printer Cartridge 053-0505-00

Printer Refill Kit 002-0371-00

VistaCool™ Direct-To-Drain Thermal Reduction System (Single) 9A586001

VistaCool™ Direct-To-Drain Thermal Reduction System (Twin) 9A586002

VistaCool Direct-to-Drain System for Autoclave Wastewater is a trademark of Crosstex International, Inc., a Cantel Medical Company, Hauppauge, NY.

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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 and 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 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 cycles. Follow the biological indicator’s instructions for proper storage, use, interpretation and disposal.

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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.

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 6000 ft. (1829 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)

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Power Cord Connection

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.

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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 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 and two ferrules. B) Install nut and ferrules onto tank hose as shown. (Large and 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

0

External Condensing Tank Connections - continued

Power Cord

Sensor Plug

0

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.

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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.

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External Condensing Tank Draining Procedure

Caution

Water that is discharged to external condensing tank can be VERY HOT; person emptying pitcher should allow the temperature to cool. Always use carrying handle and use caution when emptying.

To remove lid...

A) Rotate lid counterclockwise. B) Lift lid assembly out of condensing tank pitcher.

Lid

Assembly

To replace lid...

Note: Lid can be reinstalled in one of four locations to facilitate safe water disposal.

A) Insert lid assembly into pitcher. B) Align the four tabs for correct positioning. C) Rotate lid clockwise to secure.

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Tab

To drain pitcher...

A) Grasp pitcher by handle. B) Pour cool water into an approved drain.

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0

Distilled

Water

Operation

Quick Reference

(Detailed instructions for each step are outlined in the following pages of the Operation section).

Basic Operation...

A) Turn power switch ON (I). B) Fill reservoir. C) Load tray. D) Press desired cycle button. E) Press <Start> button.

Note

There is a 10 minute (dry) heat cycle that can be used to pre-heat the chamber, or for additional drying time. Refer to: ‘Additional Heat’ Cycle in this section.

Cycle

Buttons

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0

Power Switch

To fill reservoir...

Pour one (1) gallon of distilled water into fill port. Do not fill above lower lip of fill port.

The power cord must be connected and the power switch must be ON (I) for the sterilizer to operate.

Filling the Reservoir

Lower

Lip

Equipment Alert

Use distilled water or water that meets the referenced water purity specifications. Failure to comply may result in sterilizer malfunction and/or premature failure due

to excessive corrosion.

OFF (O)

ON (I)

Qualication Testing

Your sterilizer should be tested after sterilizer installation, malfunctions, relocation, major repairs and after sterilization process failure. Qualication testing should be performed prior to placing the sterilizer in

service. If multiple cycles types are used, e.g. “Pouches” and “Low Temp” each cycle type should be qualied. Qualication testing should include at least one Biological Indicator (BI) (sometimes referred to as Spore Tests) and one Chemical Indicator (CI). The test pack should be placed near the front of the tray and

performed with items routinely processed and considered to be the most di󰀩cult to sterilize. Additional items

should be placed in the chamber along with the Biological Indicator and Chemical Indicator so that cham-

ber is fully loaded (don’t exceed the maximum capacities listed in the tables under “Guidelines for Loading”

in this manual). Three consecutive test runs, for each cycle type tested, with negative results from the BIs and the appropriate readings from all physical monitors and chemical indicators demonstrating complete

sterilization, provide verication that the sterilizer has been properly installed (or reinstalled after relocation) or repaired to the manufacturer’s specications and that it will function e󰀨ectively in the facility in which it is installed. All items processed during qualication testing should be quarantined until the results of the

biological testing for all three test runs are available.

Loading the Tray

Types of Items Before placing any instrument in the M3, check with the instrument manufacturer to be sure the materials are compatible with steam sterilization and to verify the acceptability of sterilization parameters.

The M3 is designed to sterilize the following:

• High and low speed handpieces

• Metal instruments

• Rubber / plastic devices (ex. suction cannulas, impression trays, etc.)

• Wrapping / bundling materials (ex. CSR wrap, instrument pouches, etc.)

• Cassettes (Hu-Friedy Signa-Stat [6.5” x 10.5” x 1.25”] or smaller)

• Surgical instruments (ex. ophthalmologic instruments)

Equipment Alert

Do not sterilize items composed of any of the following materials in the M3:

• Corrosion sensitive metal (ex. carbon steel, iron, etc.)

• Fragile items susceptible to breaking under pressure / high temperature

• Liquids

• Biomedical waste

• Textiles (including towels, gauze, etc.)

• Plastics that may break down or produce residue when exposed to

steam / high temperatures. Examples Polyethylene Styrene Cellulosics ABS PVC Textiles Acrylic (Plexiglass™) PPO (Noryl™) Latex Neoprene

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Loading the Tray - continued

Immediate Use Sterilization

The M3 is capable of immediate use sterilization - sterilizing unwrapped instruments for immediate use. Please consider the following when choosing whether or not to sterilize your instruments unwrapped:

• The sterility of unwrapped instruments is compromised upon exposure to a non-sterile environment. Follow CDC guidelines for using unwrapped, sterilized instruments.

• Due to the sensitive nature of some types of surgery (including, but not limited to ophthalmological), instruments used in such procedures must be wrapped or pouched

in order to reduce their exposure to sterilization process residues. The water reservoir should also be drained and relled with fresh distilled water on a daily basis when

processing instruments for these procedures on a routine basis.

Pouching and Wrapping Items

The M3 is capable of sterilizing pouched or wrapped items.

• When pouching or wrapping items, use only sterilizer pouches and wraps that have been cleared by the FDA and labeled for use with the nontraditional steam sterilization cycle parameters, e.g. temperature and exposure time, of the M3 sterilizer. Follow the manufacturer’s instructions for use.

• When using cassettes in the M3 follow the manufacturer’s instructions for use.

• Pouched items to be sterilized should be placed lengthwise with plastic side of

pouch facing up in the M3 tray. The pouches may overlap slightly, but items must not be layered. Refer to diagram below.

POUCH

WARNING

Failure to comply with these guideline may adversely affect sterilization and/or drying.

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Loading the Tray - continued

Load Size The M3 Steam Sterilizer can accommodate loads weighing up to 2.4 lbs (1.1 kg).

[Note: This is the weight of the contents in the tray (ex. instruments, cassettes, pouches, etc.). The weight of the tray itself has already been accounted for].

WARNING

Do not overload the sterilizer tray. Failure to allow adequate space around items for circulation will compromise sterilization and drying.

Use the table below as a general guideline for weights of commonly used items.

Consult manufacturer’s specications for the exact weight of any particular instrument.

Item Description Weight*

lbs. kg

Scissors 0.066 0.030

Dental Scalers 0.044 0.020

Forceps 0.033 0.015

Dental Handpiece 0.121 0.055

Suction Cannula 0.022 0.010

Plastic Mouth Mirror 0.018 0.008

Impression Tray 0.033 0.015

Plastic X-Ray Positioning Ring 0.044 0.020

Hu-Friedy Signa-Stat Cassette 1.500 0.680

Packing the Tray

Equipment Alert

Do not use towels or packaging which contains chlorine bleach residue. Chamber and/or tray

rusting or discoloration may occur. The life of the sterilizer may be shortened significantly.

(*actual weights may vary)

WARNING

Clean and dry instruments thoroughly before placing them into tray. Improper cleaning may result in non-sterile instruments or damage to the unit. Follow instrument manufacturer’s guidelines and CDC recommendations for handling and cleaning instruments

prior to sterilization.

In addition to total load weight outlined above, all items must be processed in accordance with Centers for Disease Control and Prevention (CDC), ‘Guidelines for Infection Control in Dental Healthcare Settings’ - 2003, MMWR 2003; 52 (no. RR-17), which states:

“Items to be sterilized should be arranged to permit free circulation of the sterilizing agent (e.g., steam, chemical vapor, or dry heat); manufacturer’s instructions for loading the sterilizer should be followed.”

• All items must t in M3 tray.

• Loaded tray must slide into chamber opening without scraping.

• Items must not touch one another.

• Pouched items should be loosely packed.

• Pouches may overlap slightly, but items must not be layered.

WARNING

Failure to comply with these guideline may adversely affect sterilization and/or drying.

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Loading the Tray - continued

Begin loading

the M3

Add new item to

M3 tray.

Is item

constructed of

materials compatible

with the M3?

Yes

No

Remove item -

damage to item or

M3 could result.

No

Can item

fit within tray and

into chamber?

Yes

Can item

fit without touching

or laying on top of

other items?

Yes

Total

load < 2.4 lbs

(1.1 kg)?

Yes

Done loading tray?

No

Yes

Remove item -

it is too large for

use with M3.

Remove itemtray is at max. item capacity.

Remove itemtray is at max.

weight capacity.

End loading the

M3.

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Cycle Selection

(The parameters for each cycle are outlined on the following page.)

Select the proper

M3 sterilization

cycle.

Will you

be pouching your

instruments/handpieces

or wrapping a

cassette?

No

Unwrapped

your load contain

plastic or rubber?

speed or gentleness

to your instruments/

handpieces more

Yes

Does

No

Is cycle

important?

Pouches

Yes

GentlenessSpeed

Low Temp

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Proper Cycle

Selected.

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Cycle Selection - continued

Cycle Parameters

(Before sterilizing any items in the M3, refer to Loading the Tray in this section.)

CYCLE

Unwrapped

Pouches

Low Temp

STERILIZATION

PARAMETERS

Temperature:

270°F (132°C)

Pressure:

27.1 psi (186 kPa)

Time:

3:30 Minutes

Temperature:

270°F (132°C)

Pressure:

27.1 psi (186 kPa)

Time:

5:30 Minutes

Temperature:

250°F (121°C)

Pressure:

15.0 psi (104 kPa)

Time:

20:00 Minutes

DRY TIME ITEMS TO BE STERILIZED

Time:

25 Minutes

Time:

30 Minutes • Dental instruments / handpieces in pouches,

Time:

50 Minutes

• Dental instruments / handpieces loose on a tray.

• Items manufacturers recommend for exposure at

270°F (132°C), loose on tray.

wrapped, or in a wrapped cassette.

• Items manufacturers recommend for exposure at 270°F (132°C), in pouches, wrapped, or in a wrapped cassette.

• Rubber or plastic dental devices, dental instruments / handpieces loose on a tray, in pouches, wrapped, or in a wrapped or unwrapped cassette.

• Items manufacturers recommend for exposure at 250°F (121°C), loose on tray, in pouches, wrapped, or in a wrapped or unwrapped cassette.

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Post-Sterilization Processing

After sterilization is complete, all items must be handled in accordance with accepted and documented standards, such as the Centers for Disease Control and Prevention (CDC) document, ‘Guidelines for Infection Control in Dental Healthcare Settings’ - 2003, MMWR 2003; 52 (no. RR-17), as well as any local requirements that may apply.

Qualied personnel responsible for infection control should prepare a protocol for handling sterilized items. This protocol should be followed by all personnel responsible for handling sterilized items.

‘Additional Heat’ Cycle

The Additional Heat Cycle activates the dry heaters for ten minutes. This cycle can be used to pre-heat the chamber at the beginning of the workday, or for extended drying time at the end of a cycle.

To pre-heat chamber prior to running a cycle...

A) Press <Start> button when ‘SELECT CYCLE’ appears on display. B) During the ten minute pre-heat mode, ‘ADDITIONAL HEAT’ will flash on the display. C) When ‘ADDITIONAL HEAT’ stops flashing, press desired cycle button, then press <Start>.

For extended drying time at the end of a cycle...

A) Press <Start> button when ‘SELECT CYCLE’ appears on display. B) During the ten minute drying mode, ‘ADDITIONAL HEAT’ will flash on the display.

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Adjusting the Drying Time

The M3 allows the operator to adjust the drying time from 20 - 60 minutes using 1 minute increments for the three pre-programmed cycles.

To adjust the drying time for a pre-programmed cycle...

A) After pressing desired cycle button, press <P> button. [Display will show current setting. (ex. DRY TIME: 30 MINUTES)] B) Press the <+> / <_> buttons to increase / decrease the drying time. C) Press the <P> button to save your changes. (Pressing the <Stop> button cancels the changes and returns to last saved setting.

Maintenance

Maintenance Messages

To assure correct operation and maximum sterilizer life, the M3 provides the operator with reminders when it’s time to perform operator maintenance. After the M3 is powered ON for 7, 14 and 21 days, a message “Perform Periodic Maintenance” will be displayed. After 28 days, a “Perform Monthly Maintenance” message will be displayed. Refer to the appropriate maintenance instructions in this manual. The maintenance reminders are removed from the display when a cycle is started. If power is turned OFF, the timer will reset, initiating a new cycle of messages.

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Daily Care

• Clean External Surfaces / Tray and Chamber

A. Wash unit according to your facility’s procedure for clinical contact surfaces noting the following: (Use only quaternary disinfectants to disinfect unit. Staining, pitting, discoloration, or softening could occur if phenolic, iodophor, or glutaraldehyde-based disinfectant is used on plastic surfaces of the unit. Also, use of alcohol or aerosol spray cleaner / disinfectant containing substantial amounts of alcohol in the formula can damage the faceplate.) B. Wring excess solution from cloth. C. Using soft cloth, wipe all external surfaces. D. Follow the instructions provided with the cleaner / disinfectant used regarding rinsing and drying of external surfaces.

WARNING

Check to assure the chamber filter is not blocked by debris and that it is properly seated; in the bottom hole in the back of the chamber. Failure to make sure the filter is in place and clear of debris could result in serious personal

injury and or equipment damage.

• Clean Chamber Filter

Check that the chamber lter is free of debris and properly positioned in the hole at the back of the sterilizer chamber. If the lter is blocked by debris follow the procedures under “Monthly Maintenance”

to remove and clean the lter.

• Clean Door Gasket / Mating Surface

A. Wash with a damp cloth. B. Inspect gasket for damage. C. Replace gasket if necessary.

Chamber Filter

Door Gasket

Chamber

Filter

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• Drain / Rell Reservoir (As Needed)

A. Remove drain hose from storage location. B. Place open-end of drain hose into container or sink. C. Connect adapter-end of drain hose to coupling as shown. D. Once water has drained, press release lever and remove hose. E. Return drain hose to storage location.

F. Rell reservoir with distilled water.

Distilled

Water

Note

If coupling leaks, reinsert hose several times to clean seal.

Release Lever

Drain Hose (storage location)

Periodic Maintenance

Equipment Alert

Use distilled water or water that meets the referenced water purity specifications. Failure to comply may result in sterilizer malfunction and/or premature failure due

to excessive corrosion.

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• Empty / Clean External Condensing Tank (As Needed)

A. Empty water from tank. (Do not reuse water!) B. Clean tank with diluted bleach solution (1/4 cup bleach : 1 gallon water) and a brush. C. Rinse tank thoroughly.

D. Rell tank to minimum water level indicator line.

Note

This process is not necessary if the sterilizer is connected to a direct-to-drain thermal reduction system.

Periodic Maintenance - continued

Caution

Water may be HOT! Allow water to cool before emptying tank.

Minimum Water Level

Indicator Line

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• Clean Condensing Tank Level Sensors

Clean two sensors with mild soap solution, then wipe dry.

Note

This process is not necessary if the sterilizer is connected to a direct-to-drain thermal reduction system.

Monthly Maintenance

• Remove and Clean Filter

Wash with mild soap solution to remove debris. Rinse with distilled water.

(Use a sti brush to scrub, or place in ultrasonic cleaner if necessary.)

Level Sensors

Refer to following page for

Filter Removal / Installation

Filter

Equipment Alert

Never use abrasive or bleaching

agents to clean level sensors or filter.

English - 29

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Monthly Maintenance - continued

Tapered End

To remove filter...

A) Slide notch in filter tool (provided) over filter. B) Pull out to remove.

To install filter...

A) Position filter in notch of tool as shown. B) Align filter with hole in back of chamber* and press in gently. C) Flip tool over, then gently press filter in to secure.

*Tip: Slide tool along bottom of chamber to align filter with hole.

Filter Tool

Filter

Extended Use Maintenance

The M3 is designed and tested to provide exceptional reliability throughout its service life. However, like all electro-mechanical devices it is subject to wear and degradation with use.

To ensure the integrity, performance and safety of all major components it is the responsibility of the user to have the sterilizer performance / operation veried by a Midmark Authorized Service Provider after 8 years or 20,000 cycles of use, whichever comes rst. After 8 years or 20,000 cycles of use an annual

inspection by a Midmark Authorized Service Provider is recommended.

English - 30

003-1658-99

0

Printer (optional)

Printer Harness Connection

To connect printer harness...

A) Turn sterilizer power switch OFF (O). B) Connect printer harness as shown. C) Turn sterilizer power switch ON (I).

Power

Switch

English - 31

003-1658-99

If printer readout becomes light ...

A) Separate lid / printer from housing. B) Press Paper Feed button for three seconds. (This advances the ribbon inside the cartridge). C) Repeat step B as necessary*.

*Note: If pressing the Paper Feed button fails to correct the problem, replace the printer cartridge.

Paper Feed Button

Set Temperature and Time

BEGIN

UNWRAPPED 270 deg F 3.5 MINUTES

MM - DD - YYYY

- -

TOTAL CYCLES 140

HEATING

MM:SS degF PSI

STERILIZING

MM:SS degF PSI

MIN TEMP 271.0 degF MAX TEMP 275.7 degF MIN PRESS 23.2 PSI MAX PRESS 32.1 PSI

VENTING CHAMBER

DRYING

MM:SS 0:00

TOTAL PROCESS TIME 9:50

COMPLETE

0:00 0:30 1:00 1:30 2:00 2:30

151.5

193.1

218.1

243.2

244.6

268.5

0.1

0.2

3.8

11.9

13.5

27.8

0:00 0:30 1:00 1:30 2:00 2:30 3:00 3:30

271.0

274.8

272.9

275.1

273.7

273.8

273.5

275.2

28.8

31.6

29.2

25.8

30.8

30.0

29.3

25.8

Printer Readout

Selected Cycle

Total # of cycles

run on unit

During Sterilization phase, the printer records chamber temperature and pressure in 30-second increments.

Indicates Venting

phase initiated

Date

During Heat-Up phase, the printer records chamber temperature and pressure in 30-second increments.

Summary of Sterilization phase

Indicates Drying phase initiated (Printer records drying time in 5 minute increments).

HH : MM :

English - 32

003-1658-99

Paper Roll Installation

To install paper roll...

A) Loosen thumbscrew, then separate lid / printer from housing. B) Slide paper into slot as shown*. C) Press paper feed button until approx. 2 in. (5 cm) of paper is fed thru printer. D) Pull paper thru slot in lid. E) Position paper roll / spindle in slots. F) Reassemble lid / printer / housing.

Paper Feed

Button

*Feed Paper

from top of roll

Thumbscrew

English - 33

003-1658-99

Printer Ribbon Cartridge Replacement

To remove old printer ribbon cartridge...

A) Turn sterilizer power switch OFF (O). B) Separate lid from printer. C) Press down on side of printer cartridge labeled “EJECT”.

To install new printer ribbon cartridge...

A) Install new cartridge as shown* (it will “snap” into place). *Note: The printer paper must be between the cartridge ribbon and the metal plate. B) Turn Adjustment Knob clockwise until ribbon is tight.

Metal Plate

(Printer Paper)

Ribbon

Adjustment

Knob

Printer Paper

Cartridge

Ribbon

Troubleshooting

Error Codes

If a malfunction is detected during a cycle, a numeric error code will appear on the display panel. Use the chart below to diagnose and correct the most common, maintenance-related error codes. If you encounter an error code not identied below, follow the instructions on the display panel. If error code persists, contact your authorized service provider.

Example:

003-1658-99

Error Code Probable Cause Corrective Action

C010

C100-series (all

(C101, C102, etc.)

C231, C232

C441, C442

C533, C633 Water pump needs primed.

Sterilizer lost power

during cycle.

<STOP> button was

pressed during the cycle.

Not enough water in

reservoir to complete

the cycle.

External condensing

tank is full.

Press <STOP> button,

then restart cycle.

Press <STOP> button,

then restart cycle.

Fill reservoir with distilled water,

or water that meets the

referenced water purity specications.

Empty external condensing tank.

Put the sterilizer in the User Diagnostic Mode and prime

the pump. (see following page)

English - 34

Troubleshooting - continued

User Diagnostic Mode

The User Diagnostic Mode is used:

• To set “English” or “Metric” units on the display panel,

• To retrieve the last ve (5) error codes stored in the unit memory.

• To prime the water pump if needed.

To activate User Diagnostic Mode...

A) Turn Power Switch OFF (O). B) Press and hold the <START> button. C) Turn Power Switch ON ( I ). D) Press the <START> button when the display shows “USER DIAGNOSTIC”.

To change Display Units...

A) Put the unit in User Diagnostic Mode. B) Press the <P> button to select units. C) Press the <+> button to change the temperature and pressure display from English-to-Metric or Metric-to-English units. (Factory default setting is English). D) Press the <START> button to continue. E) Turn the power switch OFF (O) to exit User Diagnostic Mode.

To retrieve the five (5) most recent error codes...

A) Put the unit in User Diagnostic Mode. B) Press the <STOP> button to recall errors. C) The last five (5) error codes will be displayed. D) Press the <START> button to return to the User Diagnostic Mode display. E) Turn the power switch OFF (O) to exit User Diagnostic Mode.

To prime the sterilizer pump...

A) Put the unit in User Diagnostic Mode. B) Press the <START> button to start the pump priming progress. The unit will automatically cycle through a pre programmed priming cycle...

• Closing the sterilizer door.

• Heating the boiler.

• Cycling the pump ON and OFF until the pump is primed.

When finished the 2nd line of the display will show “PRIMING COMPLETE”. C) Press the <START> button to return to the User Diagnostic Menu. D) Turn the power switch OFF (O) to exit User Diagnostic Mode.

003-1658-99

English - 35

Calling for Service

Note

Please mark down any displayed Code(s) and be sure to relay this information to the service technician.

Contact your Midmark Authorized Dealer, or log on to www.midmark.com/technical-library. Model and serial number information will be required when calling for service.

To contact Midmark directly:

1.800.MIDMARK (1.800.643.6275) or 937.526.3662 8 am to 5 pm EST (Monday thru Friday) [excluding standard US holidays]

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English - 36

Specications

Fuse Ratings:

115 VAC Unit

F1 .........................................................................15 Amp, 250 V, Fast Acting, 1/4” x 1 1/4”

F2 .........................................................................0.25 Amp, 250 V, Slo-blo, 1/4” x 1 1/4”

230 VAC Unit

F1 .........................................................................8 Amp, 250 V, Fast Acting, 5 x 20 mm

F2 .........................................................................0.125 Amp, 250 V, Slo-blo, 5 x 20 mm

Certications:

ASME Boiler and Pressure Vessel Code, Section VIII, Division 1 Canadian Registration Number Available UL 61010-1, 2nd Edition IEC 61010-2-040 CAN/CSA-C22.2 No. 61010-1, 2nd Edition FCC Part 15, Sub-part B

Physical Dimensions:

Overall Length: .....................................................21 in. (53.3 cm)

Overall Width: ....................................................... 17.8 in. (45.2 cm)

Overall Height: ......................................................7.1 in. (18 cm)

Shipping Carton Length: .......................................25 in. (63.5 cm)

Shipping Carton Width:.........................................22 in. (55.9 cm)

Shipping Carton Height: .......................................16.6 in. (42.2 cm)

Counter Area: .......................................................24 in. (61 cm) deep x 22 in. (55.9 cm) wide

Chamber Volume: .................................................0.49 gal (1.8 liter)

Weight:

Empty Reservoir: .................................................. 71 lbs. (32.2 kg)

Full Reservoir: ......................................................80 lbs. (36.3 kg)

With Shipping Carton:...........................................80 lbs. (36.3 kg)

Water Reservoir Capacity: ....................................1.20 gal (4.5 liter)

Pressure Relief Valve Setting: ............................. 40 PSI (275.8 kPa)

Chamber Pressure:

@ 270°F (132°C) ....................................................27.1 psi. (186.2 kPa)

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English - 37

Water Purity Specications

Water Purity Specication Chart

Evaporate Residue ≤ 15 mg/l

Silica ≤ 2 mg/l

Iron ≤ 0.2 mg/l

Cadmium ≤ 0.005 mg/l

Lead ≤ 0.05 mg/l

Rest of heavy metals, excluding

Iron, Cadmium and Lead

Chloride ≤ 3 mg/l

Phosphate ≤ 0.5 mg/l

Conductivity (at 20°C)

pH 6.5 to 8

Appearance Colorless, clean, w/o sediment

Hardness ≤ 0.1 mmol/l (.585 gr/gal)

AAMI ST-46 (ref.)

1

2

≤ 0.1 mg/l

≤ 50 μs/cm

003-1658-99

English - 38

SCOPE OF WARRANTY Midmark Corporation (“Midmark”) warrants to the original retail purchaser that it will, at Midmark’s option, repair or

under “Exclusions”) that are defective in material or workmanship under normal use and service. The sole remedy under this limited warran-

and/or “Installation/Operation Manual” for the applicable product, including the speci ed structural and operational environmental conditions

THAT THE SOFTWARE: (1) IS ERROR FREE; (2) CAN BE USED WITHOUT PROBLEMS OR INTERRUPTIONS; OR (3) IS FREE FROM

EXCLUSIVE REMEDY; CONSEQUENTIAL DAMAGES DISCLAIMER MIDMARK’S ONLY OBLIGATION UNDER THIS LIMITED WARRAN-

TIES, EXPRESS OR IMPLIED. MIDMARK MAKES NO IMPLIED WARRANTIES OF ANY KIND INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACE-

STATUTE OF LIMITATIONS No action may be brought against Midmark for breach of this limited warranty, an implied warranty, if any, or for

Warranty Information

Scope of Warranty

replace components of the domestic and international medical products manufactured by Midmark (except for components not warranted

ty is the repair or replacement, at Midmark’s option, of the applicable components. This limited warranty shall only apply to defects that are

reported to Midmark within the applicable warranty period and which are determined to exist upon examination by Midmark,. This warranty extends only to the original retail purchaser of a product and is not transferable or assignable. Replacement components or products may be used and/or refurbished components or products, provided they are of like quality and speci cations as new components or products.

Midmark warrants to the original retail purchaser that during the applicable warranty period it will repair or replace software contained

within the products manufactured by Midmark (except for those not warranted under “Exclusions”) if: (1) the media on which the software is furnished exhibits defects in material or workmanship under normal use; or (2) the software does not substantially conform to its published speci cations.

APPLICABLE WARRANTY PERIOD The applicable warranty period, measured from the date of invoice to the original retail purchaser of

the product and shall be one (1) year for all warranted products and components.

OBTAINING WARRANTY SERVICE Warranty service must be obtained through either Midmark or an authorized dealer in the Midmark

product line for which warranty service is requested. Midmark may be contacted for warranty service inquiries or issues via email at www. midmark.com; by phone at 1.800.MIDMARK or by mail to Midmark Corporation, 60 Vista Drive, Versailles, Ohio 45380. It is the retail purchaser’s obligation to arrange for delivery of a product to Midmark or one of its authorized dealers for warranty service, which delivery shall

be at retail purchaser’s expense. It is also the retail purchaser’s obligation to comply with the warranty service instructions provided either

by Midmark or its authorized dealer. The retail purchaser must provide Midmark with completed warranty registration information within

thirty (30) days after purchase in order to obtain the bene ts of this limited warranty.

EXCLUSIONS: This limited warranty does not cover and Midmark shall not be liable for the following: (1) Defects, damage or other conditions caused, in whole or in part, by misuse, abuse, negligence, alteration, accident, freight damage, negligent storage, tampering or failure to seek and obtain repair or replacement in a timely manner; (2) Products which are not installed, used, and properly cleaned and maintained as required or recommended in the Midmark “Installation”

and electrical requirements; (3) Products considered to be of a consumable or sterile nature; (4) Accessories or parts not manufactured by Midmark;

(5) Charges by anyone for adjustments, repairs, replacement parts, installation or other work performed upon or in connection with such products which are not expressly authorized in writing in advance by Midmark; (6) Costs and expenses of routine maintenance and cleaning; and

(7) Representations and warranties made by any person or entity other than Midmark.

(8) Matching of color, grain or texture except to commercially acceptable standards; (9) Changes in color caused by natural or arti cial light;

(10) Custom manufactured products;

(11) Alterations or modi cations to the product by any person or entity other than Midmark; and

(12) Products that would otherwise by covered under this limited warranty, but are acquired: (i) from a person or entity that is not Midmark or one of its authorized dealers; or (ii) from a Midmark dealer that is not authorized to sell the product at issue in the geographic territory where the purchaser is located, or is not authorized to sell the product at issue within the medical market.

SOFTWARE; WITH RESPECT TO SOFTWARE THAT IS A PRODUCT OR COMPONENT THEREOF, MIDMARK DOES NOT WARRANT

VULNERABILITY TO INTRUSION OR ATTACK BY VIRUSES OR OTHER METHODS.

TY IS THE REPAIR OR REPLACEMENT OF DEFECTIVE PARTS. MIDMARK SHALL NOT BE LIABLE FOR AND HEREBY DISCLAIMS ANY DIRECT, SPECIAL, INDIRECT, INCIDENTAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES OR DELAYS, INCLUDING, BUT

NOT LIMITED TO, DAMAGES FOR LOSS OF PROFITS OR INCOME, LOSS OF USE, LOSS OF DATA, DOWNTIME, COVER AND

EMPLOYEE OR INDEPENDENT CONTRACTOR WAGES, PAYMENTS AND BENEFITS. THIS DISCLAIMER SHALL SURVIVE ANY FAILURE OR ASSERTED FAILURE OF THE ESSENTIAL PURPOSE OF THIS LIMITED WARRANTY OR ITS REMEDIES SPECIFIED HEREIN. WARRANTY DISCLAIMER THIS WARRANTY IS MIDMARK’S ONLY WARRANTY AND IS IN LIEU OF ALL OTHER WARRAN-

MENT OF DEFECTIVE PARTS.

any other claim arising out of or relating to the products, more than ninety (90) days following expiration of the limited warranty period.

NO AUTHORIZATION No person or  rm is authorized to create or approve for Midmark any other obligation or liability in connection with

the products.

003-1658-99

English - 39

Midmark Corporation

60 Vista Drive Versailles, OH 45380 USA

1.800.643.6275 +1.937.526.3662

www.midmark.com

003-1658-99

TP202 20-42-FO-00014 Rev A1 C2169

Midmark Corporation

60 Vista Drive Versailles, OH 45380 états-Unis

1.800.643.6275 +1.937.526.3662

www.midmark.com

003-1658-99

Français - 40

Midmark 003-1658-99ENG M3 Steam Sterilizer User Guide

Specifications and Main Features

Frequently Asked Questions

User Manual