Midmark M7 SpeedClave, M7-020 SpeedClave, M7-022 SpeedClave, M7-021 SpeedClave User Manual
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User ’s Guide
M7 SpeedClave®
Steam Sterilizer
For Models:
M7-020
M7-021
M7-022
003-1417-00 Rev . F (8/15)
SF-1849
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2
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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
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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
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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.
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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
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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)
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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 manufacturer’s instructions for proper selection, storage,
use, and interpretation of their devices.
Steam Sterilization Monitoring
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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.
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