The conformity of the quality management system is certified with Certificate No. 369CE, dated April 8, 1999 by:
AMTAC Certification Services, LTD
Norman Road, Broadheath, Altrincham
Cheshire WA 14 4EP, United Kingdom
The identification number of the notified body for implementation of the procedure set out in Annex V of the
Directive is 0473.
The authorized representative :
Medical Device & QA Services
76, Stockport Road
Timperley
Cheshire
WA15 7SN
United Kingdom
Ready
Sterilize
2
Visual Index
1 Casing with Plumbing Diagram
(inside cover)
2 Fill
3 Front Frame
4 Door with Lock
5 Drain
(quick connection behind door)
6 Front Panel Microprocessor MPU
7 Power PCB
8 RTD (Steam) Sensor
9 Reservoir with Overflow Vent
10 Water Level Switch (inside reservoir)
11 Printer Jack
12 Solenoids
13 Drying Pump
14 Master Power Switch
15 Heating Element
(mounted on bottom of chamber)
16 Safety V alve
17 Filter
18 Transformer
Operating Features
1. Power Switch/Circuit Breaker (rear of unit)
2. Reservoir Fill
3. Operation Indicator Light
4. Display Window (Pressure) kPa
5. Arrow Switches
6. Display Window (Temp/Time) C/F / Minutes
7. Clear/Start Switch
8. Low Water Light
9. Mode Selection Switch
10. Mode/Program Display
11. Power On Switch
12. Programming Switch
13. Printer On/Off Switch
14. Quick Drain Connection (inside door)
15. Leveling Feet
16. Door Lock
17. Safety Valve (rear corner of unit)
18. Operating Instructions Label
19. Caution Label
20. Serial Number Plate (inside door)
Safety Features
The design of the autoclave has these safety features for your protection:
Door Lock
Door can be opened only when internal pressure is at atmospheric pressure.
Vent Valve
The vent valve will open and the P-2 alarm will display should the chamber pressure exceed 240 kPa.
Safety Valve
The safety valve opens as backup protection should the chamber pressure exceed 262 kPa.
Overheat Protection
Chamber temperature is protected with a surface sensor so the temperature will not exceed 159°C. It has additional overheat protection
should the temperature of the heating elements reach 180°C.
Electrical Power Interruption
In case of a power failure during the sterilization cycle, pressure in the chamber is automatically vented to the atmosphere and display is
blank.
1. Digital multimeter model FLUKE 8000 A, or
equivalent.
Accuracy: AC voltage
+
0.5% of reading
-
plus 1 digit.
DC voltage
+
0.1% of reading
-
plus 2 digits.
DC current
+
0.3% of reading
-
plus 1 digit.
2. T estleads: Small needle point testleads are
required when voltage measurements are
performed at connectors which remain
plugged.
Always switch the unit OFF before connect
ing measuring instruments.
Select the correct type of current/voltage
and set the measuring range according to
the expected measured values.
Carry out continuity tests only with the unit
switched OFF.
•
Warm-up period & self-test
Do not press any buttons when switching ON!
After switching ON, the unit runs a self-test for
the unit electronics.
When using the troubleshooting trees
•
and a connector is unplugged for continuity or
voltage measurements, the term:
“at lead” indicates that the measurement is to
be performed on the cable or “lead” end.
“at board” indicates that the measurement is to
be performed on the PCB connector.
•Resetting the unit
Turn the power off at the main Power Switch.
Turn unit back on after 10 seconds..
•
Replacing parts
Switch the unit OFF and unplug before
replacing parts.
T o protect electrostatic-sensitive devices
(ESD) on PC-boards, observe the ESD
guidelines. Avoid coming into cont act with
electronics components. As well as
possible, handle PC boards only at the
edge. Discharge yourself by touching a
grounding point.
Transport PC boards only in the original
transport bags!
•Interference with electromedical devices by
radio telephones
T o guarantee the operational safety of
electromedical devices, the operation of mobile
radio telephones in the medical practice or
hospital area is prohibited.
•Troubleshooting tree guidelines
Element, component identifier: Located at the
top of each page.
Unplug X4 See Figure 22. At lead,
check continuity X4.A4 / X4.B4. Is
No
continuity present?
Yes
Refers to designated pictoral on preceeding
page.
Find article numbers required for ordering
replacement parts in the List of S pare Parts
documents, order number P/L 4702135 for the
8” unit or P/L 4702143 for the 10” unit.
The pictorial representations in the spare parts
list offer valuable assistance for replacement
of parts.
14
Removing/Reinstalling Cover
1.To remove cover, remove only the two bottom screws of rear panel.
2.Remove reservoir fill cup.
3.Slide cover to rear , then lift front of cover slightly to clear top of reservoir .
Note: When replacing cover, make sure lip of front panel engages in slot along all edges.
Reinstall screws and reservoir fill cup.
15
The S terilizer is a fully automatic autoclave, which allows an operator to select one of the four preset
functions (Wrapped, Unwrapped, Packs and Liquids) and one user-programmable function (Special) for
sterilization or disinfection. The microprocessor automatically selects the cycle time, temperature and
pressure for the preset programs. See User Manual.
When the operator depresses the “CLEAR/ST ART” button, the unit will display the selected mode’s
parameters for four seconds and then fill the chamber with distilled water from the reservoir . When the filling
period is complete, automatic activation of the heating elements builds temperature and pressure for the
desired cycle.
As the temperature in the unit rises above 90o C., the microprocessor monitors the unit for saturated steam
conditions and starts the air bleeding process via an electronic bellows function. If this process cannot be
completed in seven minutes, then the unit automatically aborts the cycle and displays a flashing “F AIL” on
the display to indicate possible blocked or defective bellows. See “FAIL” in the Troubleshooting section. The
cycle is aborted at this point to avoid a possible overpressure condition.
At the point that saturated steam conditions are met, the unit will continuously build temperature and
pressure to the minimum values of the mode selected. These values are:
134OC and 216 KPa for Wrapped and Unwrapped,
121OC and 1 15 KPa for Packs and Liquids.
For the S pecial mode, the values can be set to the operator’s preference. See User Manual.
Once sterilization parameters are achieved, if the pressure drops more than 4 KPa below the selected
pressure, or if the temperature drops more than 1OC below the selected temperature, the countdown timer
will stop until these parameters are again met. If the timer does not resume countdown within three minutes,
the unit will automatically abort the cycle and display “FAIL” continuously. See “FAIL” in the
Troubleshooting section.
After the cycle is complete and the chamber is vented, the drying cycle begins. Filtered ambient air is
pumped through the chamber for a preset time. The time is set at the factory for 30 minutes, but can be
changed from 0-99 minutes. See User Manual.
16
Error Code Explanations
1. H20- Insufficient water in sterilizing chamber.
2. Fail- a) Unit takes more than 45 minutes to reach operating temperature;
b) Door opened after “FILL”, display extinguishes;
c) Unit takes more than 7 minutes between 101
d) More than a 3 minute lapse in sterilize countdown due to leak causing more than 4 KPa
pressure or if pressure decrease.
3. Door- Door not fully closed during fill cycle.
4. P1- Pressure sensor out of calibration or not working.
5. P2- Unit reaches 241 KPa before displaying 135o C.
6. SS-1- Steam sensor is defective or autoclave is too cold (Under 10o C.).
7. SS-2- Surface sensor circuit open during self test.
8. SS-3- Steam sensor too hot (Over 140o C.).
9. LB- Low battery condition in front control panel.
o
C. and 1 10o C.;
10. U1- Transformer problem.
11. S1- Fill/ Vent solenoid coil or circuit open.
12. S2- Dump solenoid coil or circuit open.
13. S3- Bellows solenoid coil or circuit open.
17
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