Midmark M7 SpeedClave, M7-020 SpeedClave, M7-022 SpeedClave, M7-021 SpeedClave User Manual

MA514302i
R
User ’s Guide
M7 SpeedClave®
Steam Sterilizer
For Models:
M7-020 M7-021 M7-022
003-1417-00 Rev . F (8/15)
2
MA511501i
R
1
2
1
Owner’s Product Identification
(The information below is required when calling for service)
Model Number (2):
Serial Number (1):
Date of Purchase: Name of Owner / Facility:
Name of Dealer: Dealer’s Phone Number:
Midmark Authorized Service Company:
Model / Serial Number Location
Back of Unit
1
Table of Contents
Owner’s Product Identification ...................................................................................2
Calling For Service .......................................................................................................2
Important Information
Safety Symbols ...........................................................................................................3
Intended Use ..............................................................................................................4
Electromagnetic Interference...................................................................................... 4
Transportation / Storage Conditions ...........................................................................4
Safety Instructions ......................................................................................................4
Operating Environment Conditions............................................................................. 4
Electrical Requirements .............................................................................................5
Certifications ............................................................................................................... 5
Operation Precautions ................................................................................................ 6
Steam Sterilization Monitoring ....................................................................................6
Location Requirements............................................................................................... 7
Operation
Instrument Cleaning ...................................................................................................8
Loading Trays..............................................................................................................8
Recommended Temperature & Times ........................................................................9
Controls & Indicators ................................................................................................10
Preparation Before Operation ................................................................................... 11
Operation
Opening Door ........................................................................................................12
Filling Chamber .....................................................................................................12
Place Trays Into Chamber .....................................................................................13
Close & Latch Door ...............................................................................................13
Set Time & Temperature ........................................................................................14
Venting ...................................................................................................................15
Drying ....................................................................................................................15
Operator Maintenance
Cleaning ................................................................................................................... 16
Daily .......................................................................................................................16
Weekly ................................................................................................................... 17
Monthly ..................................................................................................................18
Tray Rack
Removal.................................................................................................................19
Installation ............................................................................................................. 19
Troubleshooting .........................................................................................................20
Accessories
List of Authorized Accessories ................................................................................. 21
Specifications............................................................................................................. 21
Warranty Information
Limited Warranty ....................................................................................................... 22
3
Important Information
Consult User Guide Keep dry for important information.
Proper shipping orientation Maximum stacking height
(palletted units)
Fragile
Minimum and maximum storage temperature for the unit.
Protective earth ground
Calling For Service
Note
Model / Serial Number information is required when calling for service.
Contact your Midmark Dealer, or log onto www.midmark.com to locate your nearest service provider. To contact Midmark directly:
1-800-Midmark (1-800-643-6275) or 937-526-3662 8:00 am until 5:00 pm. Monday through Friday (EST)
[excluding standard U.S. holidays]
Safety Symbols
Warning
Indicates a hazardous situation which could result in serious injury if not avoided. This symbol is used only in the most extreme situations.
Caution
Indicates a potentially hazardous situation which could result in minor injury if not avoided.
Equipment Alert
Indicates a potentially hazardous situation which could result in equipment damage if not avoided.
Note
Amplifies a procedure, practice, or condition.
4
Intended Use
This product is intended to be used in medical and dental offices, hospitals, clinics, nursing homes,
laboratories, and other facilities to sterilize heat and moisture stable, reusable equipment.
All M7 efficacy testing is exclusive of lumened device sterilization. It is our recommendation that the end-user contact the device manufacturer to determine the recommended sterilization equipment procedures and parameters
for the device being sterilized. This is consistent with a Public Health Notice for Reprocessing of Reusable Ultrasound Transducer Assemblies Used for Biopsy Procedures issued by the FDA.
Electromagnetic Interference
This Midmark sterilizer 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 and/or plug sterilizer into an isolated circuit.
Transportation / Storage Conditions
EQUIPMENT ALERT
The water must be drained from the unit’s reservoir before
transporting or storing at 32°F (0°C) or below.
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)
Safety Instructions
Primary concern of Midmark is that this equipment is operated and maintained with safety of patient and staff in mind. To assure safer and more reliable operation:
• Read and understand this manual before attempting to install or operate sterilizer.
• Assure that appropriate personnel are informed on contents of this manual; this is the responsibility of the purchaser.
• Assure that this manual is located near sterilizer, or if possible, permanently affixed to sterilizer.
Operating Environment Conditions
EQUIPMENT ALERT
Unit should be allowed to reach room temperature before
operating. Failure to do so could result in damage to the unit.
• Operating Environment
Temperature Range: ........................................ 0° F to 104°F (20°C to 40°C)
• Normal Operating Altitude: ...............................Below 9842 ft. (3000 m) above sea level.
• Device approved for
Indoor Use Only
.
Important Information
5
WARNING
Use 207 - 253 VAC, 50 HZ alternating current only for 230 VAC models
and 104 - 126 VAC, 60 HZ alternating current only for 115 VAC models. Failure to do so could result in electrical shock to personnel and will result in damage to sterilizer.
Note
Grounding reliability can only be achieved if this unit is connected to a matching three pronged, grounded, isolated, correctly polarized receptacle.
Unit Ratings:
115 VAC Unit:
115 VAC, 60 Hz, 10 Amp Dedicated branch circuit: 120 VAC, 60 Hz, 15 Amp Maximum Power Consumption: 1300 Watts
230 VAC Unit: 230 VAC, 50 Hz, 5 Amp
Dedicated Branch Circuit: 230 VAC, 50 Hz, 10 Amp Maximum Power Consumption: 1300 Watts
Fuse Ratings:
115 VAC Unit: ....................................... F1, 12 Amp, 250 V, Fast Acting, 1/4” x 1 1/4”
230 VAC Unit: ....................................... F1, 8 Amp, 250 V, Fast Acting, 5 x 20 mm
This product has been evaluated with respect to electrical shock, fire & mechanical hazards only, in accordance wit h UL61010A-1, U L61010-2- 041, CAN/CSA C22.2 NO. 1010 an d CAN/CSA C22.2 NO. 1010.2-041-96.
LA BORATOR
Y
E QUIPMENT
59FM
Equipment not suitable for use in the presence of a flammable
anesthetic mixture with air, or with oxygen, or nitrous oxide.
ISO 9001 Certified
Certifications
Electrical Requirements
• Device to be operated in a relatively dust free environment. An excessive relative humidity environment should in accordance to IEC664).
• Device should be connected to a power source with over-voltage limits less than 1500 volts from mains to ground. (Installation Category II in accordance to IEC 664)
6
Operation Precautions
EQUIPMENT ALERT
Do not use toweling or packaging which may contain chlorine bleach
residue. Doing so could result in trays and/or chamber rusting or discoloration. In extreme cases, the life of the chamber may be significantly shortened.
WARNING
Do not use
this sterilizer in an explosive or oxygen-rich atmosphere, or
where flammable anesthetics are stored. To do so could result in an
explosion or fire.
Do not use
this sterilizer for sterilizing volatile substances or for any purpose other than its intended design. Burns and toxic or explosive conditions could result.
Clean and dry instruments
before putting them into the sterilizer. Incomplete and improper cleaning of instruments will hinder sterilization. This will result in unsterile instruments which could lead to personal injury or death.
If the sterilizer malfunctions
, immediately unplug it. If it continues to malfunction, call your nearest factory trained servicer or dealer. Do not attempt to repair the sterilizer yourself or by an untrained person.
Do not force the door handle
at any time. Chamber pressure may cause the door to open with extreme force. If door handle does not move freely, allow unit to cool and depressurize for 40 minutes before attempting to open the door. Failure to comply to these instructions could result in severe personal injury.
EQUIPMENT ALERT
Processing goods using an incorrect sterilization program could result in unsterile goods and may damage instruments. Consult with your supply
manufacturer for specific sterilization instructions.
WARNING
Use process monitors with
each sterilization load
rated for use with
Gravity Displacement Steam Sterilizers
. Also, if sterilization cycle terminated
prematurely, reprocess instruments to ensure sterility of load.
Process monitors
(Rated for Gravity Displacement Steam Sterilizers)
Should be included in each sterilization cycle.
Detect whether cycle parameters were delivered.
Cannot establish that a processed item is actually sterile.
If a failure is detected, the user must determine source of failure.
(Failures could result from improper packaging, loading, or sterilizer malfunction).
Follow process monitor manufacturers instructions for proper selection, storage, use, and interpretation of their devices.
Steam Sterilization Monitoring
7
R
MA512802i
R
Follow 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.
Steam Sterilization Monitoring
Location Requirements
Overhang
Maximum 15''
(38 cm)
Height
Minimum 25''
(63.5 cm) for access to Fill
Clearance
Minimum 2 1/2''
(6.4 cm)
Surface
Must be level, water and heat (160°F[71°C]) resistance.
Depth
16 1/2" (42 cm) Minimum Includes 2'' (5 cm) clearance
behind unit.
WARNING
Do not use
this sterilizer in an explosive or oxygen-
rich atmosphere, or where flammable anesthetics
are stored. To do so could result in an explosion or fire.
8
Instrument Cleaning
ï Clean instr uments in accordance with the Manufacturer of the instruments and
OSHAís recommendations.
ï Thoroughly wash instr uments to remove gross debris (either manually or using an
ultrasonic cleaner).
ï Rinse instr uments thoroughly and dry.
ï Ster ilize jointed instruments
in an open position.
Loading T ra ys
ï Place all containers so opening allows steam to
enter and air to leave. Containers are usually positioned on side with opening tilted slightly down.
ï Pouch or wrap items to preserve
sterility after processing. Use only coverings designed and recommended for steam sterilization.
ï Do not wrap items too tightly.
Steam penetration will be affected.
ï Do not stack trays on one another.
Use Midmarkís tray rack trays provided.
ï Position loads on trays with appropriate
spacing between items for proper steam flow and drying.
ï Place unwrapped items on a towel.
** Packs to have a minimum of 1/4 in. (6.3 mm) space between each other and away from
all sterilizer surfaces.
WARNING
Clean and dry instruments before putting them into
sterilizer. Incomplete or improper cleaning of instru­ments will hinder sterilization. This will result in unsterile instruments which could lead to personal injury or death.
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9
* Exposure Time is the total time required for sterilization of the load.
This period
begins
when the sterilizer
reaches
the sterilization temperature.
Sterilization temperature
must be held
for the amount of time as recommended in the
above chart.
Not included
in Exposure Time are the time it takes to reach sterilization temperature and the
time it takes to cool back down.
Recommended Temperatures & Times
Suggested Extended Times At Reduced Temperature For Higher Altitudes
Altitudes higher than 1000 ft. (305 m) above sea level, maximum temperature that unit achieves may be less than 270°F (132°C).
Use the following to process items at the higher altitudes:
Unwrapped Items 250°F (121°C) for 15 minutes exposure time*.
• Wrapped Items 250°F (121°C) for 20 minutes exposure time*.
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10
MA512902i
R
Controls & Indicators
Cycle Timer
Controls time of cycle. Timer will buzz at end of cycle. Graduated in minutes from 0 to 30 and functions as ON/ OFF switch.
Fill / Vent Valve
Press down and hold to fill water into chamber before cycle or to vent chamber after cycle.
Reset Button
Depress to close Low Water T-stat after unit has cooled.
Door
Self-aligning, spring loaded.
Pilot Light
Illuminates when heater is energized.
Full Line
Visible thru Fill opening, shows when reservoir is at Full capacity.
Temperature Guage
Shows chamber temperature. 170°- 270°F (77°-132°C)
Temperature Regulator
Controls temperature in chamber (Maximum 270°F)
Drain Coupling
Insert adapter / hose to open valve and drain reservoir.
Door
Handle
(See Positions)
Unlatched
Vent
Latched
11
Preparation Before Operation
EQUIPMENT ALERT
Assure Sterilizer electrical specifica-
tions, as shown on Model / Serial Number label, match the electrical supply before plugging unit into outlet.
1. Plug Unit In
Plug Sterilizer into an outlet that has a dedicated circuit.
EQUIPMENT ALERT
Use only distilled or demineralized water.
Do Not use normal tap water as the minerals and chlorides in the water could adversely affect the life and reliability of the Sterilizer and articles being sterilized.
2. Fill Reservoir
Remove cap and fill with
distilled / demineralized
water to Full mark.
Full
Mark
Note
Do
not
overfill reservoir.
Overfilling may cause:
Water splashing out reservoir.
Water siphoning back into
chamber during venting.
Sterilized products could remain wet.
Water could run out bottom of door.
12
Operation
Opening Door
Filling Chamber with Water
2. Open Door
While pushing door / cross arm assembly toward right, pull outward.
1. Fill Chamber
Press down and hold Fill / Vent Lever until water is within 1/2'' (1.3 cm) of rim.
1. Unlatch Door
Place handle in Unlatched position.
EQUIPMENT ALERT
Never run the Sterilizer without the Tray Rack installed.
Note
Fill may take between 30 to 40 seconds dependent on water level in reservoir.
1/2''
(1.3 cm)
13
Place Trays Into Chamber
Close and Latch Door
1. Close Door Swing door to left
until it stops.
2. Close Door
Push door to right and swing inside chamber,then release. Door should spring back fitting inside chamber.
3. Latch Door Swing door handle
all the way to right.
1. Pack Trays Pack trays (see
Loading Trays) then load into chamber.
Note
Always include a process monitor strip with each load. Use only
Gravity Displacement
Steam Sterilizer
monitor strips.
14
MA513603i
R
Set Time & Temperature
1. Set Timer
Turn Timer knob clockwise to 15 minutes.
2. Set Temperature
Turn Temperature Control knob Fully to left (counter­ clockwise). This is maximum setting of 270°F (132°C).
Note
Place a mark on front face of Temperature Control to mark position of knob for future reference.
CAUTION
Temperatures set below 250°F
(121°C) should not be used for
sterilization, unless otherwise required by the device manufacturer. Temperatures below 250°F (121°C) are provided for disinfection only.
Note
Refer to “Recommended Temperatures & Times or to chart on top of Sterilizer for proper settings.
3. Re-Set Temp. Control
When Temperature Gauge reaches desired tempera­ ture, immediately turn Temperature knob slowly
clockwise until pilot light
goes out.
4. Re-Set Timer
After re-setting Temperature Control re-set Timer to desired sterilization time.
Note
When Timer is on Pilot Light illuminates to show Heater is on.
Temperature
Gauge
15
Venting Sterilizer
3. Vent
Hold Fill / Vent lever down until door “pops” inward. Leave door in “Vent” position.
Do not open door.
Drying
2. Vent
Swing door handle to “Vent position.
1. Vent
Turn Timer off when buzzer sounds.
1. Drying
Keep door handle in “Vent” position for 15 minutes. Do NOT open door.
2. Drying
Remove contents after Dry time has elapsed. Trays may be placed on racks on top of Sterilizer.
EQUIPMENT ALERT
Do NOT turn on heat (Timer) or open door during 15 minute
drying period.
Note
Allowing Sterilizer to set
without venting
will cause
items to come out wet
CAUTION
The metal door and surronding
metal surfaces are HOT! Use care when operating door to prevent burns.
CAUTION
The metal door and surronding
metal surfaces are HOT! Use care when operating door to prevent burns.
16
Operator Maintenance
Daily
R
MA514400
2. Door Gasket & Surface
Wipe door gasket & mating surface with a damp cloth.
3. Door Gasket
Examine gasket for damage and replace if necessary.
1. External Surfaces
Wash with damp cloth and mild soap solution, then wipe with soft, dry cloth.
Mating
Surface
Gasket
CAUTION
Make sure that Sterilizer is cool before attempting to clean to prevent personal injury from burns.
EQUIPMENT ALERT
Never use abrasive or bleaching agents (steel wool, scouring powder, bleach, etc. or a wire brush) to clean chamber. Damage to the chamber or related components could occur.
17
Operator Maintenance
Weekly
Note
Refer to “Tray Rack for Removal & Installation Instructions
MA514001
3. Remove Hose
Press down on release lever and remove hose assembly.
4. Fill Reservoir
Use only distilled or demineralized water.
1. Trays & Chamber
Wash with damp cloth and mild soap solution, then wipe with soft, dry cloth.
2. Drain Reservoir
Place end of hose in container and connect hose adapter to coupling.
Note
If drain coupling leaks after insertion or removal reinsert adapter / hose several times to clean seals, stopping leak.
Release
Lever
Drain
Coupling
Hose /
Adapter
18
MA670700i
Fill / Vent
1/2''
(1.3 cm)
Operator Maintenance
Monthly (Flush The System)
3. Fill Chamber
Press down and hold Fill / Vent Lever until water is within 1/2'' (1.3 cm) of rim.
1. Drain & Refill Reservoir
Drain reservoir and refill with clean distilled or demineralized water. (Refer to Weekly Cleaning)
4. Run Cycle
Run one 6 Minute cycle at 270°F (132°C).
7. Run Cycle
Run one 3 Minute cycle at 270°F (132°C).
8. Drain & Cool
Drain chamber and reservoir and allow sterilizer to cool, Remove trays and tray rack (Refer to Tray Rack Removal).
2. Add Cleaner
Add 1 oz. (29.6 ml) of Speed-Clean to a cool chamber.
Note
Never sterilize instruments while performing cleaning procedures.
5. Drain & Refill Reservoir
Drain chamber and reservoir and refill with clean distilled or demineralized water. (Refer to Weekly Cleaning)
10 . Refill Reservoir
Refill reservoir with clean distilled water. Install chamber filter, tray rack and trays.
9. Clean Chamber, Filter, & Trays
Remove chamber filter, wipe out chamber and clean trays and tray rack.
Filter
Full
Mark
6. Fill Chamber
Press down and hold Fill / Vent Lever until water is within 1/2'' (1.3 cm) of rim.
19
R
Tray Rack
1. Removal
Lift up on left edge of tray plate until it “pops” free of wire rack. Slide tray out of chamber.
2. Removal
Squeeze bottom of wire rack together and slide out of chamber.
2. Installation
Gently squeeze bottom of rack together and insert into chamber as far as it will go.
1. Installation
Holding tray plate with right side point down, insert into chamber.
Note
Offset ends of rack must be on left side of chamber.
WARNING
Make sure unit is cool before attempting
to remove or install tray rack and plate. Use care to prevent injury when handling metal tray rack assembly. Do NOT run sterilizer without Tray Rack assembly in place.
3. Installation
Position right side of rack under bottom wire aligning straight ends of rack with
notches on plate.
4. Installation
Holding right side of plate in position, press down left side of plate until it snaps| into offsets of wire rack.
Tray Plate
Offset Ends
Straight Ends
Tray Plate
Left Edge
Right Edge
Wire Rack
Wire Rack
20
Troubleshooting Guide
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21
Accessories
Specifications
Physical Dimensions:
Overall Length............................................................................... 48.3 cm (19 in.)
Overall Width................................................................................. 35.6 cm (14 in.)
Overall Height ............................................................................... 33 cm (13 in.)
Shipping Carton ............................................................................ 61 cm x 40.6 cm x 40.6 cm
(24 in. x 16 in. x 16 in.)
Counter Area ................................................................................ 42 cm (D) x 39.4 cm (W)
(16.5 in. x 15.5 in. includes 5 cm [2"] clearance on one side and back)
Chamber ........................................................................... 19.0 cm Diameter x 36.2 cm depth
(7.5 in. Diameter x 14.25 in. depth)
Door Opening ................................................................................. 16.8 cm (6 5/8 in.)
Large Trays (2) ........................................................................ 30.5 cm x 14.3 cm x 22.2 cm
(12 in. x 5 5/8 in. x 7/8 in.)
Small Trays (1) ........................................................................ 30.5 cm x 10.5 cm x 2.22 cm
(12 in. x 4 1/8 in. x 7/8 in.)
Weight:
Empty Reservoir ........................................................................... 13.6 kg (30 lb.)
Full Reservoir ................................................................................ 19.0 kg (41.8 lb.)
With Shipping Carton .................................................................... 17.7 kg (39 lb.)
Water Reservoir Capacity ..................................................... Approximately 4.96 Liters
to full mark (1.31 gallons).
Chamber Safety Valve ................................................................ set at 214 kPa (31 PSI)
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22
Warranty Information
SCOPE OF WARRANTY Midmark Corporation (“Midmark”) warrants to the original retail purchaser that it will repair or replace components of the domestic and international medical products manufactured by Midmark (except for components not warranted under “Exclusions”) that are defective in material or workmanship under normal use and service. Midmark’s obligation under this warranty is limited to 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, upon examination by Midmark, prove to be defective. This warranty extends only to the first retail purchaser of a product and is not transferable or assignable.
APPLICABLE WARRANTY PERIOD The applicable warranty period, measured from the date of delivery to the original user, 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; by facsimile at 1-800-365-8631; 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 benefits of this warranty.
EXCLUSIONS This 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, 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 in the Midmark “Installa­tion” and/or “Installation/Operation Manual” for the applicable product; (3) products considered to be of a consumable 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.
EXCLUSIVE REMEDY; CONSEQUENTIAL DAMAGES DISCLAIMER: MIDMARK’S ONLY OBLIGATION UNDER THIS WARRANTY 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, DOWNTIME, COVER AND EMPLOYEE OR INDE­PENDENT CONTRACTOR WAGES, PAYMENTS AND BENEFITS.
NO AUTHORIZATION No person or firm is authorized to create or approve for Midmark any other obligation or liability in connection with the products.
WARRANTY DISCLAIMER THIS WARRANTY IS MIDMARK’S ONLY WARRANTY AND IS IN LIEU OF ALL OTHER WARRANTIES, 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 REPLACEMENT OF DEFECTIVE PARTS.
STATUTE OF LIMITATIONS No action may be brought against Midmark for breach of this limited warranty, an implied warranty, if any, or for any other claim arising out of or relating to the products, more than ninety (90) days following expiration of the limited warranty period.
Midmark Corporation 60 Vista Drive Versailles, OH 45380-0286 937-526-3662 Fax 937-526-5542 midmark.com
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