003-2237-00-User Guide-Asepsis21 Delivery Systems

003-2237-00-User Guide-Asepsis21 Delivery Systems
User Guide
Asepsis 21®
Delivery Systems
Introduction............................................ 2
Labels & Symbols.................................. 2
Intended Use......................................... 3
Electromagnetic Interference................ 3
Calling for Service................................. 3
Specifications / Compliance Chart ....... 3
Disposal of Equipment.......................... 3
Transportation / Storage /
Operating Conditions........................... 3
Manual Shutoff Valves /
Pressure Regulator Valves................. 4
Controls................................................. 5
Operation .............................................. 7
Cleaning & Maintenance.......................
Chair Mounted Units.......................... 16
Cabinet Mounted Units ..................... 17
Doctor’s / Hygienist’s Carts............... 17
Assistant’s Cart ................................. 18
Left / Right Duo Cart ......................... 18
Warranty Information........................... 19
Language of origin: English
Refer to compliance chart
in this manual.
Asepsis-1
Part No. 003-2237-00 Rev. E (9/9/15)
Introduction
Your Asepsis 21 Delivery system has been designed and manufactured with care and you in mind. It is constructed of the highest quality material to provide years
of trouble-free service.
The instrument head provides for the control of up to five air operated handpieces and a 3-way syringe. The handpieces are stored in their respective holders
which may be rotated to your preferred position. When the handpiece is removed from the holder, it is automatically selected to operate when the foot control is
depressed.
Your new Asepsis 21 also features a handpiece lubricant collection system. The handpiece exhaust tubes from the four port handpiece tubes are connected to a
collector jar which is located on the bottom center of the instrument head. The collection jar can be removed to be emptied and cleaned simply by unscrewing it
from the unit. The collector jar should be inspected daily and emptied when approximately 1/2 inch of oil has accumulated.
The aerodynamic shape of the instrument head lends itself to easy cleaning or wrapping for infection control.
Symbols
These symbols may appear on your equipment and/or in the manuals Warning and cautions are provided in the manuals where applicable.
Consult Manuals
Type B,
Applied Part
warning
Indicates a potentially hazardous situation which
could result in serious injury if not avoided.
Pressure
Limit
Type BF,
Applied Part
Caution
Indicates a potentially hazardous situation which may result in minor or moderate injury if not avoided. It may
also be used to alert against unsafe practices
Equipment Alert
Indicates a potentially hazardous situation which
could result in equipment damage if not avoided.
100 F
Protective Earth
Ground
Proper Shipping Orientation
Fragile
NOTE
38 C
Temperature
Limit
23 F
-5 C
Humidity
Limit
Maximum stacking
height (Refer to “n”
number on package.)
Amplifies a procedure, practice, or condition.
Keep Dry
© Midmark Corporation 2010
Asepsis-2
Intended Use
Specifications
Midmark delivery systems are intended to provide dental
professionals with air, water and suction to operate dental
handpieces, syringes, and Midmark authorized accessories
during dental examinations and procedures.
Air / Water Pressure
Operating Ranges:
Air: 80/100 PSI
Water: 30/50 PSI
Classifications
Class I, Type B, Applied Part,
Ordinary Equipment. [IPXO]
Optional Accessories:
Electromagnetic Interference
Handpiece tubing and connectors intended
to be used with ISO 7785-1 or ISO 7785-2
compliant air-driven handpieces
Midmark dental operatory components are designed and
built to minimize electromagnetic interference with other
devices. However, if interference is noticed between another
device and this operatory, remove the interfering
device from room and / or plug product into an isolated circuit.
warning
Equipment is not suitable for use in the presence
of a flammable anesthetic mixture with oxygen, air, or nitrous oxide.
Calling For Service
Clarification: Equipment is suitable for use in the presence
of oxygen, air, or nitrous oxide.
Direct all service inquiries to your authorized Midmark dealer.
When calling for service, you must provide the following information:
Type B Applied Part
Disposal of Equipment
Model / serial number
Date of purchase
Symptom(s) of malfunction
At the end of this product’s life, the unit, accessories and
other consumable goods may be contaminated from normal
use. Consult local codes and ordinances for proper disposal
of this equipment and other consumable goods.
Authorized EU Representative
Countries in the EU should direct all questions, incidents, and
complaints to Midmark’s Authorized EU representative listed below.
Transportation / Storage / Operating Conditions
Midmark EMEA Ltd
Beech House, First Floor, East Wing, Ancells Business Park
Fleet
Hampshire GU51 2UN
United Kingdom
Tel: + 44 (0) 1252 360 940
Fax: + 44 (0) 1252 360 941
Transportation / Storage Temperature:.........23°F to 100°F (-5°C to +38°C)
Relative Humidity:........................................ 10% to 90% (non-condensing)
Atmospheric Pressure:.................. 7.2 PSI to 15.3 PSI (50 kPa to 106 kPa)
Operating Temperature Range: .......................59°F to 95°F (15°C to 35°C)
Complies To:
Description
Mounted on
(Type)
Asepsis 21 Delivery Systems
Ultra Chair
Asepsis 21 Delivery Systems
Knight Chair
or Carts
© Midmark Corporation 2010
UL
60601-1
(2nd
Edition)
•
CAN / CSA
22.2,
#601.1 - M90
Electrical Ratings:
ES/IEC/
EN
60601-1
EN
60601-1-2
(EMC Standards)
CAN /
CSA
22.2,
#60601.1
CE
•
•
•
•
•
Asepsis-3
Volt
+/- 10%
Maximimum
Connected
Load
Cycles
(Hz)
Power Supply Model No.:
153808-001, -002
N/A
120
15 A
50/60
240
7.5 A
50/60
Manual Shut-Off Valves / Pressure Regulator Valves
Manual shut-off valves allow you to stop the air and/or water supply at the point of input to the operatory. This is recommended during
extended periods of non-use (ex. vacation, holidays, etc.), or in the event of an equipment malfunction.
Pressure regulator valves allow you to control the air and water pressure supplied to the instruments of the delivery system.
City Water
Gauge
Water Bottle
Regulator
DO NOT ADJUST
City Water
Regulator
Adjustment
Knob
Shut-off Valves
Rotate clockwise 1/4
turn to Shut off.
Air
Regulator
Adjustment
Knob
Water Manual
Shut-off Valve
To Adjust the Pressure Regulators...
A) Pull up knob and turn to adjust.
B) Watch regulator gauge as you turn knob to achieve desired setting.
40
20
2
60
3
4
5
0
80
0
1
6
7
100
Air Manual
Shut-off Valve
Air Regulator
Gauge
Turn Counter-Clockwise
for less pressure
Turn Clockwise
for more pressure
Recommended Settings:
Factory set to 30 psi
DO NOT adjust
5
6
7
0
0
Water Bottle Regulator
Setting
4
80
Air Pressure
80 psi
RegulatorGauge Setting
Equipment Alert
Delivery components were designed
to operate at the recommended
settings. Poor performance or damage to the
equipment may result if recommended settings
are not maintained.
10
City Water
30 psi
RegulatorGauge Setting
KA947002
© Midmark Corporation 2010
Asepsis-4
Controls
Asepsis 21 Instrument Head: A complete set of handpiece and syringe adjustments are located directly under the magnetically held cover for protection against
contamination. Lift up either back corner of the cover for easy removal. All controls are labeled with symbols identifying their function.
1
2
3
9
Coolant Air Volume Adjustment
Handpiece Coolant Water Volume
This adjustment controls the volume of coolant
delivered to each handpiece. It affects the
spray pattern of air and water at the handpiece.
If the handpiece has a coolant air connection in
the handpiece itself, this adjustment will have
no effect and can be completely shut off.
Adjusts the amount of coolant water to each
respective handpiece.
4
5
6
Drive Air Pressure Setting
10
Individual adjustments are provided - one for
each respective handpiece. Set the maximum
handpiece pressure indicated on the gauge.
Refer to the handpiece manufacturer’s
specifications for proper setting.
Handpiece Pressure Gauge
Indicates individual handpiece pressure when
the handpiece is operating.
7
11
12
13
Syringe Air Volume Adjustment
Magnetic Latches
Controls the volume of air to the syringe and
effects water spray pattern.
These hold the cover in place.
8
14
Syringe Water Volume Adjustment
Handpiece Coolant Water Flush Button
Controls the volume of water to the syringe and
effects water spray pattern.
© Midmark Corporation 2010
Controls the coolant water flush valve and is located
on the underside of the delivery head.
Asepsis-5
Controls - continued
External Controls
Main ON / OFF Valve
Arm Lock (chair mtd. units only)
Located on the bottom center of the instrument
head directly behind the handpiece holder bar
support, this two position toggle control turns
the main air and water ON / OFF.
(See illustration below)
Located on the bottom of the instrument head
adjacent to the handle, this two position toggle
controls the arm lock mechanism.
Assistant’s Instrumentation
Water Outlet and Flow Control
A saliva ejector, HVE and syringe are
standard instrumentation on the unit. They are
positioned on a movable holder located on
the console. Syringe tip, saliva ejector valve
assembly and HVE valve assembly are easily
removed for sterilization.
Located on the front panel of the console, the
water outlet provides water for hydrocolloid
tubing or other accessories. The water is
controlled by a flow control knkob located next
to the water outlet. Turning the knob clockwise
decreases water flow, and counterclockwise
increases the flow.
Water Selector Switch
Automatic Handpiece Activation
This switch, located on the front of the console
or the LR arm, allows you to choose the water
source for the delivery system. You may select
either “City” water (tap water), or water from
the Self-Contained Water System bottle.
The automatic kink valves are designed to
permit activation of the selected handpiece
when it is removed from its holder. Drive air will
be delivered to the withdrawn handpiece when
the foot control is depressed.
“City” water
Water ON / OFF Valve
Blue dot indicates
“wet” operation
Located on the foot control, this switch
provides water for coolant spray to the
handpiece when the switch is moved forward
to the ON position (toward the blue dot) and
the foot control is depressed (wet cutting).
When the valve is in the OFF position, water
will not be delivered to any handpiece.
(See illustration below).
Self-Contained
Water System
Wet / Dry Foot Control
The disc-type foot control operates the
selected handpiece at varying speeds
depending upon the foot pressure applied to
the disc. Positioning the coolant water selector
toggle allows coolant water for wet cutting to
be selected by the motion of the foot. Applying
foot pressure to the disc will operate the
selected handpiece and, if turned ON, water
spray. (See illustration below).
© Midmark Corporation 2010
Asepsis-6
DA
Operation
The automatic kink valves are designed to permit activation of the selected handpiece
when it is removed from its holder. Drive air will be delivered to the withdrawn handpiece
when the foot control is depressed. (See the illustration)
Basic Operation:
Step 1: Turn ON the master valve lever located on the underside of the Asepsis 21 instrument head.
Step 2: Flip the wet/dry toggle on the
foot control to the desired position.
Step 3: Lift the handpiece from its holder
and depress the foot control.
Step 4:
© Midmark Corporation 2010
If necessary, make adjustments by lifting the cover off the Asepsis 21 head and
adjusting the control knobs as desired. (See Controls section)
Asepsis-7
Cleaning, Disinfecting & Maintenance
ATTENTION
Midmark assumes no responsibility or liability for any result, expressed or
implied. These are suggested practices, based on the best information
available at this time this is written..
Barrier
Scheduled Maintenance Chart
Area
Frequency
Unit surfaces
as necessary
Hoses
as necessary
Vacuum system
as necessary
Solids collector
daily
Regulator filters (air / water)
every 3 months
Barrier
Barrier
DA178400i
Barriers
Single-use barriers and disposable items significantly reduce the need for chemical disinfectants,
thus prolonging the life of the equipment. Barrier material must be impervious to moisture / fluids.
Examples of protective barriers:
• Plastic covers (available from your dealer or equipment manufacturer)
Read all labels
carefully!
• Clear plastic wrap
• Plastic bags
• Plastic sheets
• Plastic tubing
• Plastic-backed paper
• Materials similar to those listed here
Cleaning and Disinfectant Procedures
• Organization for Safety & Asepsis Procedures:
http://www.osap.org
Use cleaners and disinfectants that are appropriate for the situation, such as warm water and mild
detergents, or a 10% solution of bleach with water.
• American Dental Association:
http://www.ada.org
NOTE
Every dental practice is different, and no single disinfectant is the best choice for every facility. Listed
below are some organizations to assist you in choosing the best disinfectants available for your
practice.
• Dept. of Health & Human Resources
Centers for Disease Control & Prevention (CDC):
http://www.cdc.gov
• European Dental Association:
http://www.eda-eu.org
© Midmark Corporation 2010
Asepsis-8
Cleaning, Disinfecting & Maintenance (continued)
Barriers
General Purpose Cleaning
Midmark recommends the use of disposable barriers on all clinician controls
that may be in contact with clinician hands and fingers during dental
procedures. The use of barriers significantly reduces the need for chemical
cleaners, thus prolonging the life of the equipment.
Use cleaners and disinfectants that are appropriate for the situation,
such as warm water and mild detergents, or a 10% solution of bleach
with water.
Only use barrier material that is intended for use with dental equipment.
Midmark recommends the use of an FDA market-cleared barrier such as
Pinnacle Cover-all™. Follow barrier manufacturer instructions for proper use
of these products.
Visual Inspection
Cleaning and Disinfecting
After cleaning, visually inspect the product for deterioration of
covers and touch pads. Do not use the delivery system if excessive
discoloration, cracking, or other signs of wear are noticeable (see
Calling for Service instructions).
Cleaning and Disinfecting Assistance
In addition to the use of barriers Midmark recommends the use of an EPA
registered and FDA market-cleared cleaner/disinfectant such as Cavicide™
to be used on all clinician controls or surfaces that may come in contact with
dental instruments during dental procedures.
Follow cleaner/disinfectant manufacturer instructions for proper use of the
product. Care should be taken to avoid excessive application and pooling of
liquids.
For assistance with cleaning and disinfecting instructions contact the
Midmark Technical Service Department at 1-800-Midmark, it is helpful
to provide the delivery system model number and serial number when
asking for assistance.
Additional information is available from the organizations listed below:
Handpiece Accessories
• Organization for Safety & Asepsis Procedures
http://www.osap.org
Only use dental handpiece accessories with the delivery system that are FDA
market-cleared and refer to manufacturer’s instructions for proper cleaning
and disinfecting. Either an autoclavable syringe tip or a single use disposable
syringe tip may be used.
• American Dental Association:
http://www.ada.org
• European Dental Association:
http://www.eda-eu.org
Equipment Alert
AUTOCLAVABLE SYRINGE TIP STERILIZATION
The autoclavable syringe tips supplied with the delivery system must be
sterilized prior to use with each patient, including initial use. Be sure to thoroughly
rinse and clean syringe tips prior to sterilization, any debris may reduce the
effectiveness of the sterilization. Recommended sterilization process is steam
autoclave. Recommended parameters are 125°C (250°F) and 106 kPa (15 PSI) for 40
minutes at temperature and pressure.
© Midmark Corporation 2010
• Dept. of Health & Human Resources
Centers for Disease Control & Prevention (CDC):
http://www.cdc.gov
Asepsis-9
Cleaning the Delivery System
At the beginning of each day...
Fill the Self contained water bottle with fresh water and
perform a Purging Procedure.
Note: See Purging Procedure described in this manual.
DA101201i
Note:
Water must be safe for drinking.
Distilled water is not required.
For each new patient...
Replace disposable tips, instruments, etc. and
perform a Purging Procedure.
Note: See Purging Procedure described in this manual.
DA2536i
© Midmark Corporation 2010
Asepsis-10
Cleaning the Delivery System - At the end of each day...
Equipment Alert
B) Mix approximately 10% bleach (use only
5.25% bleach solution) with 90% water.
A) Remove disposable tips,
instruments, etc.
Use only 5.25% bleach solution.
Do not use bleach with scents, color
guards, or other additives. Mix fresh every day.
Note: Use fill marks on the newer Midmark water bottles
for quick measures..
DA2536i
C) Perform a purging procedure. Leave the bleach mixture in the system for 10 - 20 minutes, then remove. Empty and rinse the water bottle
Note: See Purging Procedure described in this manual.
~90%
~10%
D) Fill the water bottle with fresh water and perform a
purging procedure. Repeat as many times as
needed, until all the bleach odor is gone.
Equipment Alert
Do not leave bleach mixture in system longer than 30 minutes. Doing so may damage the delivery system .
E) Turn Master Switch OFF.
Press and hold the foot control pedal until all pressure is released.
DA2538i
© Midmark Corporation 2010
Asepsis-11
Purging Procedure for the Delivery
NOTE:
The purging procedure removes debris from the tubing to the handpieces and syringe.
Performing this procedure frequently may help reduce the accumulation of biofilm on your instruments.
To begin the purging procedure...
A)
B)
C)
D)
Flush the tubing to the handpieces ...
Turn Master Switch ON.
Turn Water Selector Switch to bottle setting
Move the foot control switch to the water setting.
Disconnect handpiece from tubing.
A) Press and hold the foot control pedal for 30 seconds.
B) Press and hold the flush button for 30 seconds.
C) Repeat for all tubing to the handpieces.
Master
Switch
SLIDE
ON
Position
Water
Selector
Switch
Water
Foot Control Switch
Flush the Syringe Tubing...
Caution
Hold the tubing and syringe over a
container or drain while flushing.
A) Press and hold both syringe buttons (air and water) for 30 seconds.
DA255901i
© Midmark Corporation 2010
Asepsis-12
Air/Oil Separator - Cleaning and Maintaining
Periodically check the fluid level in the air / oil separator container.
When the container is approximately 2/3 full, clean the air/oil
separator as shown below.
To clean the air/oil separator...
A)
B)
C)
D)
E)
Turn master ON/Off switch Off.
Remove (unscrew) air/oil separator container.
Dispose of the fluid and saturated gauze.
Disinfect container and mounting cap.
Install clean gauze and reinstall the container.
© Midmark Corporation 2010
Asepsis-13
Maintaining and Replacing the Regulator Filters
Step 1: Shut off manual valves to turn off water and air supplies to the operatory.
Manual Shut
Off Valves
40
20
60
3
2
4
5
0
80
0
1
6
7
100
40
20
2
60
3
4
5
0
80
0
1
6
7
100
Step 3: Unscrew retainer nut and remove filter.
Retainer Nut
Filter
Step 4: Install new filter.
Secure with retainer nut.
Note: Install the filter & retainer nut with the ridged
side up (as shown).
Filter Cap
Step 2: Unscrew filter cap.
Note: Use 9/16” wrench.
Step 5: Reinstall filter cap.
KA947500
© Midmark Corporation 2010
Asepsis-14
Assistant’s Units - Cleaning
Note:
Every dental practice is different, and no single
disinfectant is the best choice for every facility.
See the list of organizations that may assist you in
choosing the best disinfectants available for your
practice, in the front of this manual.
To clean the facility vacuum system...
Refer to the instructions provided by the vacuum system’s manufacturer.
To clean the solids collector...
A)
B)
C)
D)
Turn facility vacuum OFF.
Remove lid and basket.
Clean basket and housing.
Reinstall basket and lid.
Caution
Always dispose of biohazardous
debris according to local regulations.
DA178800i
© Midmark Corporation 2010
Asepsis-15
Dimensions / Range of Motion
Chair Mounted Units
Maximum load on Flex Arm
mounted units is 7 lbs (3.2 KG)
18.12"
14.3"
Asepsis 21
Delivery Head
KA940100
CONCEPT LR UNIT
© Midmark Corporation 2010
Asepsis-16
CHAIR MOUNTED CONSOLE UNIT
KA940200
Dimensions / Range of Motion - continued
Cabinet Mounted Units
Doctor’s / Hygienist’s Carts
16.50"
18.15"
18.86"
28.25"
TO
36.75"
13.00"
© Midmark Corporation 2010
Asepsis-17
AF1119
Dimensions / Range of Motion - continued
Assistant’s Cart
© Midmark Corporation 2010
Left / Right Duo Cart
Asepsis-18
Warranty Information
SCOPE OF WARRANTY
Midmark Corporation (“Midmark”) warrants to the original purchaser its Dental
products and components (except for componentsnot warranted under “Exclusions”)
manufactured by Midmark to be free from defects in material and workmanship under
normaluse and service. Midmark’s obligation under this warranty is limited to the
repair or replacement, at Midmark’s option, of the parts or the products the defects of
which are reported to Midmark within the applicable warranty period and which, upon
examination by Midmark prove to be defective.
5. INTEGRA™ DENTAL CASEWORK AND ARTIZAN™ DENTAL FURNITURE
PRODUCTS are warranted against defect in material and workmanship for the
period indicated below from the time of delivery:
(a) Five (5) years for all products and components (except for the shorter periods
in (b and c), including plastic laminate top surfaces, door and drawer fronts,
casters, and electrical components such as task lights and cords. (b) Three (3)
years for task light ballast. (c) One year (1) for plastic laminate, solid surface
countertops and accessories.
APPLICABLE WARRANTY PERIOD
EXCLUSIONS
The applicable warranty period, measured from the date of delivery to the original user,
shall be as follows:
This warranty does not cover and Midmark shall not be liable for the following;
1. DENTAL PRODUCTS are warranted against defect in material and workmanship
for the period indicated below from the time of delivery:
(a) Two (2) years for all products and components (except for the
periods in b thru e).
(b) “KINK-VALVE” module carries a ten (10) year warranty.
(c) The original light bulb on a new light carries a one (1) year warranty.
(d) Accessories not manufactured by Midmark are excluded.
(e) Replacement parts and accessories carry a ninety (90) day warranty.
EXCLUSIVE REMEDY
2. Oral Surgery PRODUCTS are warranted against defect in material and
workmanship for a period of one (1) year from the time of delivery.
Midmark’s only obligation under this warranty is the repair or replacement of defective
parts. Midmark shall not be liable for any direct, special indirect, incidental, exemplary
or consequential damages or delay including, but not limited to, damages for loss of
profits or loss of use.
3. STERILIZERS PRODUCTS are warranted against defect in material and
workmanship for a period of one (1) year from the time of delivery.
4. ULTRASONIC CLEANER PRODUCTS when used in accordance with
manufacturer’s instructions and under normal use, are guaranteed for two (2)
years after date of shipment. Within the period guaranteed, the manufacturer
will repair or replace free of charge, at its sole discretion, all parts that are
defective because of material or workmanship including costs for removing or
installing parts. Repairs are made on a FOB repair depot basis. Manufacturer’s
liability, whether based on warranty, negligence or other cause, arising out of
and/or incidental to sale, use or operation of the transducer elements, or any
part thereof, shall not in any case exceed the cost of repair or replacement of
the defective equipment, and such repair or replacement shall be the exclusive
remedy of the purchaser, and in no case shall manufacturer be responsible for
any and/or all consequential or incidental damages including without limitation,
and/or all consequential damages arising out of commercial losses.
© Midmark Corporation 2010
(1) repairs and replacements because of misuse, abuse, negligence, alteration,
accident, freight damage, or tampering; (2) matching of color, grain, or texture
except to commercially acceptable standards; (3) changes in color caused by natural
or artificial light; (4) products which are not installed, used, and properly cleaned
as required in the Midmark “Installation” and or “Installation/Operation” Manual for
this applicable product; (5) products considered to be of a consumable nature; (6)
accessories or parts not manufactured by Midmark; (7) specially manufactured
products; (8) charges by anyone for adjustments, repairs, replacement parts
installation, or other work performed upon or in connection with such products which is
not expressly authorized in writing in advance by Midmark.
NO AUTHORIZATION
No person or firm is authorized to create for Midmark any other obligation or liability in
connection with the products.
THIS WARRANTY IS MIDMARK’S ONLY WARRANTY AND IS IN LIEU OF ALL
OTHER WARRANTIES, EXPRESSED OR IMPLIED. MIDMARK MAKES NO
IMPLIED WARRANTIES OF ANY KIND INCLUDING ANY WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE. THIS
WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT OF DEFECTIVE
PARTS.
Asepsis-19
Midmark Corporation
60 Vista Drive
Versailles, OH 45380 USA
1-800-643-6275
1-937-526-3662
www.midmark.com
© Midmark Corporation 2010
Asepsis-20
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