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• Operator’s Manual STATIM ® 900J AUTOCLAVE 95-110106 JP EN R2. Copyright © 2017 SciCan Ltd. All rights reserved. .

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Page 1: STATIM 900J AUTOCLAVE - SciCan (CA)

• Operator’s Manual

STATIM®

900J AUTOCLAVE

95-1

1010

6 JP

EN

R2.

Cop

yrig

ht ©

201

7 Sc

iCan

Ltd

. All

right

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ed. .

Page 2: STATIM 900J AUTOCLAVE - SciCan (CA)

STATIM 900J Operator’s Manual

2

1. Introduction ...........................3

2. Important Information ...........42.1 Disclaimers2.2 Unit Overview 3. Installation .............................63.1 Environmentall Considerations3.2 Unit Placement3.3 Connecting The Waste Bottle3.4 Filling The Statim Reservoir3.5 Priming The Statim 900J Pump3.6 Language Selection3.7 Setting the Time and Date3.8 Preparing The Unit For Use3.9 Shipping The Unit4. Instructions For Use ............104.1 Using The Sterilization

Chamber Drawer4.2 Preparing and Loading

Instruments4.3 Instrument Mass Guide4.4 Selecting A Cyle4.5 Running A Cycle4.6 Stopping a Cycle4.7 Biological Indicators4.8 Chemical Indicators

5. Maintenance .......................195.1 Cleaning the Chamber5.2 Cleaning The Exterior Surfaces5.3 Preventative Maintenance Schedules5.4 Spare Parts List6. Troubleshooting

Problems ............................. 22

7. The Communication Port ....247.1The RS232 Communication Port7.2 Installing the SciCan Data Logger7.3 Cycle Printout Overview8. Warranty ...............................30

9. Statim 900J Specifications ......................31

Manufactured by: SciCan Ltd. 1440 Don Mills Road, Toronto ON M3B 3P9 CANADA Phone: (416) 445-1600 Fax: (416) 445-2727 Toll free: 1-800-667-7733

Table Of Contents

STATIM is a registered trademark of SciCan Ltd. STAT-DRI and Your Infection Control Specialist are trademarks of SciCan Ltd. All other trademarks referred to in this manual are the property of their respective owners.

For all service and repair inquiries: In Canada: 1-800-870-7777 International: (416) 446-4500 Email: [email protected] DMAH:

AJMD K.K.Hisamatsu Rotary Bldg.4-7 Hisamatsu-cho, Nihonbashi Chuo-ku Tokyo 103-0005 Tel: 03-5614-0733Fax: 03-5614-0734

Controlled Medical Device (Class II) Approval No. 222AABZ100071000

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Table Of Contents

The STATIM® 900J autoclave has been designed expressly for the rapid sterilization of instruments intended for immediate use. This allows you to sterilize instruments between patients. To decrease instrument turn-around time, the Statim 900J does not have a post-sterilization drying cycle. Quick drying and cooling of the load at the end of the cycle is achieved through evaporation after the automatic opening of the sterilization chamber drawer. Because of the unique operation of the Statim 900J, once the instruments are exposed to ambient conditions, their continued sterility cannot be assured. It is recommended to use these instruments immediately after they are comfortable to the touch. The Statim 900J has three sterilization cycles:The Solid Instrument Cycle is used to sterilize solid metal instruments. The sterilization phase of this cycle is at 134°C for 3.5 minutes. For a detailed description of this cycle, please see page 14.The Hollow or Wrapped Instrument Cycle is used to sterilize dental handpieces. The sterilization phase of this cycle is at 134°C for 5 minutes. For a detailed description of the cycle please see page 15.The Rubber or Plastic Instrument Cycle is used to gently sterilize rubber and plastic instruments. The types of materials appropriate for this cycle are outlined in Preparing and Loading Instruments. The sterilization phase of this cycle is at 121°C for 15 minutes. For a detailed description of this cycle please see page 15.

1. Introduction

Figure 1

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2.1 DisclaimersUse only steam-process distilled water in your Statim. Specially filtered water should not be used. Never use tap water. Usage of any water other than steam-process distilled water may damage the unit and void the warranty.

Do not permit any person other than certified personnel to supply parts for, service or maintain your Statim. SciCan shall not be liable for incidental, special or consequential damages caused by any maintenance or services performed on the Statim by a third party, or for the use of equipment or parts manufactured by a third party, including lost profits, any commercial loss, economic loss, or loss arising from personal injury.

Never remove the cover of the unit and never insert objects through holes or openings in the cabinetry. Doing so may damage the unit and / or pose a hazard to the operator.

IMPORTANT: Follow local guidelines governing verification of the sterilization procedure.

2. Important Information

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1. Reservoir cap2. Liquid crystal display (LCD)3. Keypad4. Level indicator5. Drawer6. Sterilization chamber7. Power switch8. Power cord9. Leveller feet10. Waste bottle (condenser) and coil assembly11. TeflonTM

exhaust tube12. Exhaust fitting 13. Drain Tube

When you recieve your Statim 900J packing carton, the items listed below will be included.If any of the items are missing, contact your dealer immediately so the situation can be corrected.

2. Important Information 2.2 Unit Overview

Important Information.

A potential Hazard to the operator.

A situation which may lead to a mechanical failure.

The following symbols appear in the margins of this book

2

41

3

10

8

13

9

Figure 2

5

Tube Mounting Hardware

Waste Bottle part number 01-100724S

Bottle Lid Fitting part number 01-100735S

Multifunction button

Solid Instrument cycles

Hollow or Wrapped Instrument cycle

Rubber / Plastic cycle

Caution: Hot Surface and / or Hot Steam

Caution: Risk of electrical shock. Disconnect supply before servicing

Statim 900J Operator’s Manual part number 95-110106

6

127

Stat-Dri part numbers: 2OZPLUS, 32OZPLUS, 8OZPLUS, 8OZPLUS (with trigger)

Power Cord part number 01-101763S

Exhaust Tube part number 01-100204S

11

The following symbols appear on the unit

14

14. Communications port

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3.1 Environmental ConsiderationsThere are several factors that may effect the performance of your Statim. Please review these factors, and select a suitable location in which to install the unit.• Temperature and Humidity

Avoid installing your Statim in direct sunlight or close to a heat source (e.g. vents or radiators). The recommended operating temperature is between 15 ˚C to 25 ˚C (59 ˚F to 77 ˚F) with humidity of 25 % to 70 %.• Spacing

The vents and openings on the Statim should remain uncovered and unobstructed. Leave a minimum of 50 mm / 2 " between the top, sides and back of the unit and any wall or partition.• Venting

The Statim should be operated in a clean, dust-free environment.• Work Surface

The Statim should be placed on a flat, level, water-resistant surface. Never install and operate the unit on a sloped surface.• Electromagnetic Environment

The Statim has been tested and meets applicable standards for electromagnetic emissions. While the unit does not emit any radiation, it may itself be affected by other equipment which does. We recommend that the unit be kept away from potential sources of interference.• Electrical Requirements

Use properly grounded and fused power sources with the same voltage rating as indicated on the label at the back of your Statim. Avoid multiple outlet receptacles. If using a surge suppressor power bar, plug in one Statim only.

3.2 Unit Placement To stabilize the Statim 900J, follow these steps:1. Align the bubble (1)

in the level indicator (2) on the front panel to the right front quadrant (or 4 o’clock) of the target by adjusting the four leveller feet (3). This will ensure that the Statim 900 functions properly.

2. Ensure that all four feet are in contact with the surface, and that the Statim 900J does not rock.

1. Bubble2. Level indicator3. Leveller feet4. Reservoir

cap

Figure 3

4

2

1

3 (4x)

3. Installation

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3.3 Connecting the waste bottleTo connect the waste bottle (1), follow these steps:1. Insert one end of the

Teflon™ exhaust tube (2) into the exhaust fitting (3) on the back of the Statim 900J. Push the tube into the fitting as far as it will go to ensure that the tube is connected tightly.

2. Cut the tube to length and slide the nut, ring and cone onto the tube. Place the free end of the tube into the fitting in the lid of the waste bottle and hand tighten. Do not coil the exhaust tube.

3. Place the waste bottle near the Statim 900J. We recommend that you keep it in a cabinet below the unit. For convenience, the tube can be routed through a hole, 7 mm (5/16") in diameter, drilled through the counter-top and secured with the nylon clamps provided.

4. Unscrew the lid with the copper condenser coil assembly from the waste bottle. The lid and coil should come out together. Fill the waste bottle with water to the “MIN” line and replace the lid and copper condenser assembly.

5. If required, a low-level disinfectant prepared according to instructions on the disinfectant packaging may be added to the waste bottle. This may help prevent unpleasant odours or discoloration of the waste water if it is not changed regularly.

3.4 Filling the Statim ReservoirTo fill the reservoir, follow these steps:1. Remove the reservoir cap from the top of

the Statim 900J and pour only steam- process distilled water into the reservoir until nearly full (a maximum of 3 litres). Never use tap water. We recommend using a funnel when filling the reservoir to avoid spills. Pour slowly when filling the top portion of the reservoir. Use only steam processed distilled water containing less than 5 ppm total dissolved solids (having conductivity of less than 10 μS / cm).

1. waste Bottle2. Teflon™ exhaust tube3. exhaust fitting

4. nut5. ring6. cone7. threaded nut

3

2

456

71

Figure 4

Figure 5

3. Installation

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2. Replace the reservoir cap to ensure that nothing other than steam-process distilled water enters the reservoir.

3. Empty the waste bottle and refill to the MIN indicator.

3.5 Priming the Statim 900J pumpTo Prime the Statim 900J pump follow these steps:1. Carefully turn the Statim 900J sideways,

and locate the drain tube beside the power switch, on the back of the unit. Gently pull the tube out as far as possible so the free end can be positioned over a water container.

2. Remove the stopper from the end of the drain tube and allow water to drain from the tube into a container for at least 30 seconds.

3. Replace the stopper, and feed the tube back into the unit until secure. 4. Plug the power cord into the power cord receptacle on the back of the unit.5. Plug the power cord into a standard, grounded, wall outlet.

3.6 Language SelectionTo set the language feature for the Statim 900J, follow these steps. Watch the blinking cursor on the LCD.1. Turn the Statim 900J power switch OFF. 2. Press and hold down the Hollow or Wrapped Instrument Cycle button on

the front of the Statim 900J, and turn the power switch at the back of the unit ON. Release the Solid Instrument Cycle button. The current language selection will appear.

3. To scroll to the next language press the Hollow or Wrapped Cycle button. To scroll to the previous language press the Solid Instrument Cycle button.

4. When the desired language feature is indicated on the LCD, press the MULTIFUNCTION button shown to save the change and return to normal operation.

3.7 Setting the Time and DateTo set the time and date, follow these steps and watch the blinking cursor on the LCD:1. Power the Statim OFF.2. Press and hold the Solid Instrument cycle button.3. While pressing the Solid Instrument cycle button, power the Statim ON.

The LCD display reads:

Figure 6

3. Installation

14:23 06/22/2007HH:MM DD/MM/YYYY

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4. Use the cycle buttons to select and change the selected field’s value. To increase a field’s value, press the Solid Instrument cycle button. Hold the button down to increase the value.

5. To decrease the value, press the Hollow or Wrapped Instrument cycle button.

6. To select the next field, press the RUBBER AND PLASTICS cycle button.7. To save changes and return to the regular operating mode, press the

MULTIFUNCTION button.8. To quit without making changes, power the Statim OFF.

3.8 Preparing Unit for UseOnce the unit is installed and before any instruments are sterilized, run two Hollow or Wrapped instrument cycles (See section 4.5 Running a Cycle). Clean the drawer and the instrument basket using a soft cloth to wipe the inside surfaces and rinse thoroughly with tap water. Once the instrument basket and sterilization chamber are clean and dry, coat the interior surfaces with Stat-Dri.

3.9 Shipping the Statim 900J If you must ship the Statim 900J, follow these instructions:1. Drain the water from the reservoir. Carefully turn the Statim 900J backwards.

Locate the drain tube beside the power switch on the back of the unit. Release the drain tube from the clip.

2. Remove the stopper from the end of the drain tube and allow for the water to drain freely from the reservoir. When the water no longer drips from the drain tube replace the stopper and secure the drain tube under the clip.

3. Installation

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4.1 Using The Sterilization Chamber DrawerThe Statim 900J keypad has four buttons. The first three buttons will initiate one of the three different sterilization cycles. These cycles are described in detail in section 4.4 Selecting A Cycle. The fourth button on the keypad, the MULTIFUNCTION button, opens and closes the Sterilization Chamber Drawer.

• To open the Sterilization Chamber Drawer:1. Press the MULTIFUNCTION button and the drawer will open automatically. 2. Lift the instrument basket from the sterilization chamber.3. Load instruments to be sterilized into the instrument basket. Ensure you

follow the instrument manufacturer’s reprocessing instructions to ensure you do not damage the instruments.

4. Replace the instrument basket into the sterilization chamber.5. Press the MULTIFUNCTION button and the drawer will close automatically,

or press one of the sterilization cycle buttons and the drawer will close and the selected sterilization cycle will begin automatically.

• To Remove The Sterilization Chamber Drawer:To remove the sterilization chamber drawer, follow these steps:1. Open the drawer by pressing the

MULTIFUNCTION button on the keypad.

2. Turn the unit power switch to OFF.3. Locate the green latch inside the

front opening of the machine near the top right hand side. Push the latch to the right and gently pull the drawer out of the unit.

Be careful. The instruments and the metal parts of the drawer may be hot.

• To Replace The Sterilization Drawer:To replace the sterilization chamber drawer, follow these steps:1. Center the drawer into the opening.2. Rest the rear ends of the drawer on the front rollers in the opening.3. Tilt the front of the drawer upwards and push the drawer into the unit. Level

the drawer and continue to push until the drawer clicks into the intermediate position. Lift and push the drawer past the position where the green latch is engaged by the drawer.

4. If installed properly, the drawer cannot be removed without pushing the green latch.

5. Turn the power ON and close the drawer by pressing the MULTIFUNCTION button.

Rubber & Plastic

Cycle

Handpieces / Hollow

Instrument Cycle

Solid Instrument

Cycle

4. Instructions for Use

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4.2 Preparing and Loading InstrumentsBefore loading any instruments into the Statim, consult the instrument manufacturer’s reprocessing instructions.• Clean Instruments

Clean and rinse all instruments before loading them into the cassette. Disinfectant residues and solid debris may inhibit sterilization and damage the instruments, the sterilization chamber, and the Statim. Lubricated instruments must be wiped thoroughly and any excess lubricant should be removed before loading.• Solid Instruments

Arrange unwrapped instruments in the instrument basket so that they do not touch one another. This ensures that steam reaches all surfaces.Instruments must not be stacked or piled in the instrument basket as this will impede the sterilization process.The Statim 900J provides cycles to sterilize instruments for both immediate and future use.• Immediate use

Use the Solid Instrument cycle only if the instruments are going to be used immediately following sterilization. Handpieces should be sterilized in the Hollow or Wrapped instrument cycle even for immediate use. Since the item is not wrapped for processing, the sterilized item should be used immediately (as soon as it cools off) and must be protected from re-contamination during transport to the point of use. The rapid timing of the Solid Instrument cycle (about 6 minutes) is sufficient to sterilize instruments between patients. • Hollow or Wrapped Instruments

If the instruments are going to be stored for future use, place the instruments into autoclave bags according to the instrument manufacturer’s instructions. Pouch each instrument individually. Place one pouch on the bottom rack and another one on the top rack of the basket. The Statim 900J unit does not have an active drying process and handling of wet pouches will compromise the sterility of the instruments. Following sterilization, the wet pouches may be allowed to dry within the drawer of the unit or can be transported to the cabinet in the basket and allowed to dry in the basket prior to further handling. Care should be taken that the basket and contents remain protected from re-contamination during this drying period. The use of cloth wraps in the Statim is not recommended. SciCan recommends the use of plastic / paper autoclave bags such as SPS™, Medi-Plus™ and Chex All II™. Steri-Stik™ paper / paper may also be used. The use of cloth wraps in the Statim is not recommended. Loosely pack instruments in the bags to allow steam penetration to all instrument surfaces. Care must be taken to ensure that the combined weight of the loaded bags does not exceed 1.0 kg (2.2 lbs).

4. Instructions for Use

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• Rubber and Plastic Instruments

The following materials CAN be sterilized in the Statim: nylon, polycarbonate (Lexan™), polypropylene, PTFE (Teflon™), acetal (Delrin™), polysulfone (Udel™), polyetherimide (Ultem™), silicone rubber, and polyester. When loading rubber and plastic instruments in the instrument basket, leave a space between the instruments and the chamber walls. This ensures that steam reaches all surfaces. The following materials CANNOT be sterilized in the Statim: polyethylene, ABS, styrene, cellulosics, PVC, Acrylic (Plexiglas™), PPO (Noryl™), latex, neoprene, and similar materials. Use of these materials may lead to instrument or equipment damage. If you are unsure of your instrument’s material or construction, do not load into your Statim until you have checked with the instrument manufacturer.• All Instruments

The Statim is NOT intended for sterilizing textiles, liquids or biomedical waste. Unwrapped instruments, once exposed to ambient or external conditions, cannot be maintained in a sterile state. If sterile storage is desired, wrap the instruments to be sterilized in autoclave bags, according to the instrument manufacturer’s instructions. Then allow the wrapped cycle to run. At completion of cycle, handle load acepticallyBest Practice: Allow instruments (wrapped or unwrapped) to dry completely prior to handling. Wrapped or pouched instruments must not touch each other to promote drying and enable effective sterilization.SciCan recommends the final user carefully choose the most appropriate sterilization cycle according to the recommendations of their leading infection control authorities and local regulatory guidelines / recommendations. • Routine Monitoring

SciCan recommends that chemical process indicators suitable for steam sterilizers be used in routine monitoring of the Statim 900J. Of the many brands on the market, it is important to choose the correct type. Use only indicators designed for steam sterilization at 134°C for the Solid Instrument and Hollow or Wrapped Instrument cycles, and indicators designed for steam sterilization at 121°C for the Rubber or Plastic Instrument cycle. Use at least one indicator for each load processed. Follow the indicator manufacturer’s instructions closely.

Cycle Biological Indicator

Incubation Period

Test Pack

Solid Instruments

Attest™ 1261

24 Hours Place the indicator in the center of the unloaded instrument basket.

Hollow or wrapped instruments

Attest™ 1261

24 Hours Place the indicator in the center of the unloaded instrument basket.

Rubber & Plastic Instruments

Attest™ 1262

48 Hours Place the indicator in the center of the unloaded instrument basket.

4. Instructions for Use

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For detailed instructions on how to handle, use and dispose of both the biological and chemical indicators, please consult the product literature accompanying the 3M Attest™ biological indicators or contact the manufacturer directly.To use the indicators with the Statim 900J, follow these steps:1. Place the appropriate biological indicator in the Statim 900J chamber.2. Process the load in the sterilizer according to your usual practice.3. Ensure that the message “Cycle Complete” is displayed on the LCD after

the cycle is finished.4. Recover the biological and / or chemical indicator and process further

according to the literature that accompanied the indicator.At the first indication of a potential sterilization failure:1. Do not process any more instruments until favourable test results have

been returned.2. Ensure the correct indicator type was chosen.3. Ensure the chamber was not overloaded. Consult the earlier portion of this

section for proper loading instructions.4. If the results do not change, do not process any more instruments within the

Statim 900J and contact your SciCan dealer for further assistance.Because the turnaround time for the 3M Attest™ is up to 48 hours, it is recommended that the tests be conducted so that the incubation period occurs during a period of planned downtime such a the last cycle before a weekend.

4.3 Instrument Mass GuideInstrument Typical Instrument Mass

Scissors 30 g (0.96 ozt)

Dental Scalers 20 g (0.64 ozt)

Forceps 15 g (0.48 ozt)

Dental handpiece 40 to 60 g (1.3 to 1.9 ozt)

Unwrapped instrument rack 225 g (7.23 ozt)

Suction cannula 10 g (0.32 ozt)

Plastic mouth mirror 8 g (0.3 ozt)

Impression Tray 15 to 45 g (0.48 to 1.5 ozt)

Plastic x-ray positioning ring 20 g (0.64 ozt)

NOTE: The above weights are to be used as reference only. For exact weights of your instruments, consult the manufacturer's specifications.

4. Instructions for Use

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4.4 Selecting a CycleThe Statim 900J Autoclave has been designed expressly for the rapid sterilization of instruments intended for immediate use. This allows you to sterilize instruments between patients. Quick drying and cooling of the load at the end of the cycle is achieved through evaporation after the automatic opening of the sterilzation chamber drawer. Because of the unique operation of the Statim 900J, once the instruments are exposed to ambient conditions, their continued sterility cannot be assured. It is recommended to use these instruments immediately after they are comfortable to the touch. Each cycle can be selected by pressing the Solid Instrument, Hollow or Wrapped Instrument, or Rubber / Plastic buttons.The types of instruments, sterilization requirements and a graph depicting each cycle characteristics are described over the following pages.The Statim 900J has three sterilization cycles, each designed to sterilize a specific type of instrument. The instruments will remain sterile after a successful cycle until the drawer is opened. The types of instruments, sterilization requirements, and a graph depicting each cycle are described over the next few pages. Consult the Instrument Mass Guide in Section 4.3 for information on how to make up an appropriate load for the masses specified for individual cycles.

1. Solid Instrument Cycle

The Solid Instrument Cycle is used to sterilize solid metal instruments free from deep cavities or holes, such as pliers, burrs, scalers and forceps.The maximum recommended load for the Solid Instrument Cycle is 1.0 kg. To select this cycle, press the Solid Instrument Cycle button. The cycle then starts automatically. This cycle is illustrated in the graph below. During the sterilizing phase of this cycle, the temperature in the chamber is maintained at a minimun of 134ºC for 3.5 minutes. See Preparing and Loading Instruments before running this cycle.

SOLID 134°C / 3.5 min

A B D EC

A Warming upB ConditioningC Pressurizing

D SterilizingE Venting

4. Instructions for Use

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2. Hollow or Wrapped Instrument Cycle

The Hollow or Wrapped Instrument Cycle is used to sterilize dental handpieces. The maximum recommended load for the Handpiece cycle is 1.0 kg. To select this cycle, press the Hollow or Wrapped Instrument Cycle button. The cycle then starts automatically. This cycle is illustrated in the graph below. During the sterilizing phase of this cycle, the temperature in the chamber is maintained at a minimum of 134ºC for 5 minutes. See Preparing and Loading Instruments before running this cycle.

3. Rubber or Plastic Instrument Cycle

The Rubber or Plastic Instrument Cycle is used to sterilize instruments constructed of the materials listed under the heading Rubber or Plastic Instruments in Preparing and Loading Instruments. The maximum recommended load for the Rubber or Plastic Instrument Cycle is 0.1 kg. To select this cycle, press the Rubber or Plastic Instrument Cycle button. The cycle then starts automatically. This cycle is illustrated in the graph below. During the sterilizing phase of this cycle, the temperature in the chamber is maintained at a minimum of 121ºC for 15 minutes. See Preparing and Loading Instruments before running this cycle.

4. Instructions for Use

HOLLOW OR WRAPPED 134°C / 5 min

A B C E D

A Warming up B Conditioning C Pressurizing

D Sterilizing E Venting

RUBBER / PLASTIC 121°C / 15 min

A B C EDA Warming upB ConditioningC Pressurizing

D SterilizingE Venting

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4.5 Running a Cycle

To operate each cycle, follow these steps and watch the LCD:

Turn the power switch at the back of the unit ON. The LCD display reads:

Selecting the MULTIFUNCTION button changes the position of the drawer

or

Selecting a cycle will close the door and start that cycle.

Select the apropriate cycle button on the keypad located beside the LCD.

As the drawer closes, the display reads

and the cycle begins. Messages change throughout the cycle. For example, if the SOLID INSTRUMENT CYCLE is selected, the following LCD messages would be displayed:

if the drawer is ajar

STATIM 900J R1.11

SELECT A CYCLE PRESS TO CLOSE

if the drawer is fully open

if the drawer is closed

Rubber & Plastic

Cycle

Hollow or Wrapped

Instrument Cycle

Solid Instrument

Cycle

4. Instructions for Use

SELECT A CYCLE PRESS TO OPEN

SELECT A CYCLE PRESS TO OPEN

SOLID INSTRUMENTS 134ºC for 3.5 mins

HOLLOW OR WRAPPED INSTRUMENTS 134ºC for 5 mins

RUBBER AND PLASTICS 121ºC for 15 mins

SOLID INSTRUMENTS WARMING UP

SOLID INSTRUMENTS WARMING UP 96ºC

SOLID INSTRUMENTS CONDITIONING 110ºC

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After venting is complete, the drawer will open automatically and the instruments may be removed. The display reads:

Be careful. The instruments and metal parts of the drawer will be hot. Hot steam will escape as the drawer opens. This message is displayed for 30 minutes as a reminder of a successfully completed cycle. When sterilized instruments are removed press the MULTIFUNCTION button to clear the CYCLE COMPLETE message, and prepare the machine for the next cycle. This ensures that the CYCLE COMPLETE message is not displayed when a new load of unsterilized instruments is placed in the chamber.After 30 minutes the LCD message will automatically change to:

Once exposed to a non-sterile environment at the end of a complete cycle, the continued sterility of the chamber contents can no longer be assured. Therefore, the Statim 900J should only be used for the prevention of cross-contamination, unless other steps are taken to ensure continued sterility.

SELECT A CYCLE PRESS TO CLOSE

4. Instructions for Use

SOLID INSTRUMENTS PRESSURIZING 130ºC

STERILIZING 134ºC 212 kPa 3:15

SOLID INSTRUMENTS VENTING 115ºC

SOLID INSTRUMENTS CYCLE COMPLETE 6:02

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4.6 Stopping a CycleTo stop a cycle, press the MULTIFUNCTION button. If the MULTIFUNCTION button is pushed, or the unit detects a problem while operating, the cycle will stop and the amber active light will flash. Once a cycle has been interrupted, the MULTIFUNCTION button must be pressed before another cycle can be started. The display reads the following message:

If the display shows the message, CYCLE FAULT or NOT STERILE, the chamber contents are not sterile! See section 6. Troubleshooting for more information.

4. Instructions for Use

BUTTON PRESSED PLEASE WAIT

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5.1 Cleaning the ChamberIt is good clinical practice to keep your Statim 900J sterilization chamber clean. We recommend that the interior surface of the chamber be cleaned at least once a week with dishwashing soap or mild detergent that does not contain chlorine.Remove the drawer from the unit to make cleaning easier. See, section 4.1. Afterwards, rinse thoroughly to remove all traces of soap. After the chamber is clean treat the entire inside surface with Stat-Dri. Stat-Dri causes water to form an even coat on treated surfaces, without beading. The water in contact with the hot chamber surfaces evaporates more efficiently. Spotting is minimized and instruments dry faster. Stat-Dri is available from your dealer or from SciCan.Cleaning the inside of the chamber is very important if you regularly sterilize lubricated instruments.

5.2 Cleaning the Exterior SurfacesUse a soft cloth moistened with a mild cleaning solution or mild disinfectant to clean all outer surfaces. Do not use solvents or harsh chemicals.

5.3 Preventative Maintenance SchedulesTo ensure trouble-free performance, both the operator and the dealer must follow a preventative maintenance schedule.NOTE: Please refer to your National, Regional, State or Safety laws for any additional reoccurring user testing that may be required.

5. Maintenance

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The schedules below describes the necessary actions.

Operator

Daily Chamber Wash the interior of the sterilization chamber with a chlorine-free dishwashing detergent or soap. Rinse thoroughly with water.

Unit After a week or period of extended non-use, run the first cycle with an empty load.

Water Reservoir Drain Daily Waste Bottle Empty the waste bottle every time you refill

the reservoir. Fill with tap water up to MIN line. You can also add some chlorine-free disinfectant.

technician

Once Chamber Check the drawer, lid and seal for damage. a year Replace if necessary.

Solenoid Valve Inspect the valve and clean if dirty. Replace the plunger if defective. Pump Clean the filters, replace if dirty. Water Reservoir Check the reservoir for dirt. Clean and

rinse with steam process distilled water if necessary.

Calibration Calibrate the unit

5. Maintenance

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5.4 Spare Parts List

01-100204S Exhaust Tube

01-101561S Packaging

01-101565S Condenser Bottle

01-101582S Replacement Cap

01-103636S Wire Basket Complete

01-104343S Plug - Drain Tubing

01-101562S Statim 900J Drawer

2OZPLUS Stat Dri Plus 2oz. bottle w/sprayer

32OZPLUS Stat Dri Plus, 32oz. bottle

8OZPLUS Stat Dri Plus, 8oz. bottle

8OZPLUST Stat Dri Plus, 8oz. bottle w/trigge

5. Maintenance

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Problem Solution

Unit Does not Power ON.

Check that the unit is plugged into a properly grounded outlet, that the power cord is firmly seated at the rear of the machine, and that the power switch is ON.Check the condition of the line circuit breaker or fuse.

Drawer does not open / close when a cycle button or the multifunction button is pressed.

The drawer may not be installed properly. Push the drawer further into the unit assuring that it is past the position where the green latch is engaged by the drawer.When installed properly the drawer may not be pulled out of the unit without pushing the green latch. See, section 4.1, Using the Sterilization Chamber Drawer

Water under the Machine

Check that water was not spilled when refilling the reservoir. We recommend that you use a funnel when filling your Statim 900J .Make sure the plug in the drain tube is secured. If the leak persists, unload the chamber, unplug the unit, and call your dealer.

Cycle aborted, message “NOT STERILE” and “CYCLE FAULT” message

Wait a few minutes and attempt another cycle before proceeding.Check the exhaust tube for kinks or obstructions. Try another cycle. If the problem persists, record the cycle fault message number and contact your dealer.

Message “CYCLE FAULT 12”

Do not attempt another cycle. There is an internal electrical problem. Turn the unit off, unload the sterilization chamber and call your dealer.Be careful. The instruments and metal parts of the drawer will be hot. Hot steam will escape as the drawer opens.

Excessive steam is issuing from the front of the unit

Open and close the drawer. Attempt another cycle.Be careful. The instruments and metal parts of the drawer will be hot. Hot steam will escape as the drawer opens.If the leak persists, unload the chamber, unplug the unit, and call your dealer.

6. Troubleshooting Problems

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Problem Solution

Unit Does not Power ON.

Check that the unit is plugged into a properly grounded outlet, that the power cord is firmly seated at the rear of the machine, and that the power switch is ON.Check the condition of the line circuit breaker or fuse.

Drawer does not open / close when a cycle button or the multifunction button is pressed.

The drawer may not be installed properly. Push the drawer further into the unit assuring that it is past the position where the green latch is engaged by the drawer.When installed properly the drawer may not be pulled out of the unit without pushing the green latch. See, section 4.1, Using the Sterilization Chamber Drawer

Water under the Machine

Check that water was not spilled when refilling the reservoir. We recommend that you use a funnel when filling your Statim 900J .Make sure the plug in the drain tube is secured. If the leak persists, unload the chamber, unplug the unit, and call your dealer.

Cycle aborted, message “NOT STERILE” and “CYCLE FAULT” message

Wait a few minutes and attempt another cycle before proceeding.Check the exhaust tube for kinks or obstructions. Try another cycle. If the problem persists, record the cycle fault message number and contact your dealer.

Message “CYCLE FAULT 12”

Do not attempt another cycle. There is an internal electrical problem. Turn the unit off, unload the sterilization chamber and call your dealer.Be careful. The instruments and metal parts of the drawer will be hot. Hot steam will escape as the drawer opens.

Excessive steam is issuing from the front of the unit

Open and close the drawer. Attempt another cycle.Be careful. The instruments and metal parts of the drawer will be hot. Hot steam will escape as the drawer opens.If the leak persists, unload the chamber, unplug the unit, and call your dealer.

6. Troubleshooting Problems

Problem Solution

Message “WATER QUALITY IS NOT ACCEPTABLE”. Machine will not start

Inadvertently, you have used water which is not steam-process distilled or is improperly distilled. Drain the reservoir and refill with steam-process distilled water To drain the unit, use the drain tube at the back of the machine. Refer to the steps described in Shipping the Statim 900J.

Message “REFILL RESERVOIR” and “EMPTY WASTE BOTTLE”. Machine will not start.

The level of water in the reservoir is low. Refill the reservoir, using steam-process distilled water and empty the waste bottle. Refer to the steps described in Maintaining the Statim 900J.

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7. The Communication Port

7.1 The RS232 Communication PortAll Statim units that do not have an internal printer will have an RS232 communication port that will allow you to connect to an external printer or to a SciCan Data Logger. For printing, you will need to purchase a recommended printer (see list below) from your local computer or electronics store. For data storage, you can purchase SciCan’s USB Data Logger to record and store cycle information onto a mass storage device (MSD) such as a USB Flash Drive or SD memory card.

Printer Model End Of Line CR/LF

Serial Port Bitrate

Printer user ° character

Epson TM-U220D (C31C515603)

CR/LF

9600

248 [0xF8]

Citizen IDP-3110-40 RF 120B

CR

9600

N/A

Star MicroSP212FD42-120

CR

9600

210 [0xd2]

Star MicroSP216FD41-120

CR/LF

9600

210 [0xd2]

Star MicroSP512MD42-R

CR/LF

9600

210 [0xd2]

SciCan Data Logger End Of Line CR/LF

Serial Port Bitrate

Printer user ° character

For mass storage device* N/A 9600 32 [0xd2]* Due to a variety of software programs/viewers that can be used to view the

data files stored on a mass storage device such as a USB memory stick, we recommend the above settings.

For your Statim to communicate to a specific device, you must enable this function through the User Setup menu. Follow the instructions in section 7.2 Installing the SciCan Data Logger below to enable communication to either an external printer or the SciCan Data Logger.

Figure 5

Data Logger

Printer

OR

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7. The Communication Port

7.2 Installing the SciCan Data Logger

SciCan’s USB Data Logger can record and store cycle information onto a mass storage device (MSD) such as a USB Flash Drive or SD memory card. These instructions are for units with a 9-pin communication (RS232) port located at the back of the unit.

User Setup Menu

To install the SciCan Data logger, access the user setup menu by powering up the unit while pressing the MULTIFUNCTION button. Follow the instructions below to complete installation steps.

STEP 1Selecting the USB Flash/MSD Option

1. Power up unit while pressing the MULTIFUNCTION button to access the User Setup menu.

2. Using the Solid Instrument or Hollow or Wrapped Instrument Cycle buttons, scroll to RS232 and select it by pressing the Rubber and Plastic Cycle button.

3. From the RS232 menu, use the Solid Instrument or Hollow or Wrapped Instrument Cycle buttons to scroll down to the USB/FLASH MSD option and press the Rubber and Plastic Cycle button to select and return to the User Setup menu.

USB/Flash MSDRS232

User Mode

Time/Date Setup Language Setup Unit ID Setup Water Quality Last Printout RS232 End of Line CR/LF Serial Port Bitrate Printer User º Char Save and Exit Exit

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Setting the Serial Port Bitrate to 9600

1. From the User Setup menu, use the Solid Instrument and Hollow or Wrapped Instrument Cycle buttons to scroll to the Serial Port Bitrate menu and select it using the Rubber and Plastic Cycle button.

2. From the Serial Port Bitrate menu, use the Solid Instrument or Hollow or Wrapped Instrument Cycle buttons to scroll down to 9600 and press the Rubber and Plastic Cycle button to select and return to the User Setup menu.

Setting the Printer user Character; (example: 134°C)

1. From the User Setup menu, use the Solid Instrument or Hollow or Wrapped Instrument Cycle buttons to scroll to the Printer user ° char menu and select it using the Rubber and Plastic Cycle button.

2. From the Printer user ° char menu, using the Solid Instrument cycle button to increase the displayed value by one, and the Hollow or Wrapped Instrument Cycle button to increase that value by ten, enter the value 32 [0x20] and press the Rubber and Plastic Cycle button to accept and return to the User Setup menu.

Save and Exit

A Save and Exit must be performed after the above settings are completed. If this is not done, the information will revert to its prior settings.1. From the User Setup menu, use the Solid Instrument or Hollow or Wrapped

Instrument Cycle buttons to scroll to Save and Exit.2. Select it by pressing the Rubber and Plastic Cycle button.

The LCD will display time and date information and a sequence of messages:

If the time and date need to be adjusted, refer to section 3.7, Setting The Time and Date.

9600Serial Port Biterate

HH:MM DD/MM/YYYY

"MSD NOT DETECTED"/"INSERT MSD/FLASH"/"SELECT A CYCLE"

7. The Communication Port

32 [0x20]Printer User º Char

Save and Exit

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Step 2Selecting the Time and Date

Note: If the time and date were set according to section 3.7, this does not have to be performed again.1. Power up unit while pressing the MULTIFUNCTION button to access the

User Setup menu.2. Using Solid Instrument or Hollow or Wrapped Instrument Cycle buttons,

scroll to Time / Date Setup and press the Rubber and Plastic Cycle button to select it.

3. From the Time / Date Setup menu, set the time and date using the Solid Instrument or Hollow or Wrapped Instrument Cycle buttons to change the displayed values and the Rubber and Plastic Cycle button to select. Press the MULTIFUNCTION button when completed to save your selection.

Step 3Setting Unit ID

1. Power up unit while pressing the MULTIFUNCTION button to access the User Setup menu.

2. Using the Solid Instrument or Hollow or Wrapped Instrument Cycle buttons, scroll to the Unit ID Setup and press the Rubber and Plastic Cycle button to select it.

3. From the Setup Unit ID menu, use the Solid Instrument or Hollow or Wrapped Instrument Cycle buttons to Change the displayed values and the Rubber and Plastic Cycle button to select and move to the next digit. Press the MULTIFUNCTION button when completed to save your selection.

Step 4Connecting the SciCan Data Logger

1. Ensure that both the Statim unit and the SciCan Data Logger are OFF.

2. Connect the SciCan Data Logger to the Statim unit by using the serial cable.3. Power up the SciCan Data Logger4. Power up the Statim unit.5. The LCD will display the following

sequence of messages:6. Insert USB Flash Drive or SD memory card7. After a few seconds the LCD will display the

following sequence of messages:

HH:MM DD/MM/YYYYTime/Date

7. The Communication Port

001UNIT ID

HH:MM DD/MM/YYYY

"MSD NOT DETECTED"/"INSERT MSD/FLASH"/"SELECT A CYCLE"

HH:MM DD/MM/YYYY

USB/FLASH DETECTED/SAFELY REMOVE MSD/SELECT A CYCLE

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7.3 Cycle Printout Overview1. Model: STATIM 900J

software: SJ00R6042. Unit Identifier: autoclave

has been set up as number 000

3. Cycle counter: the number of cycles having been run on the unit = 6

4. Time / Date: 4:10 pm Dec. 4, 2007

5. Cycle Name: SOLID INSTRUMENT CYCLE

6. Cycle Name: Cycle name parameters 134 C for 3.5 min.

7. Cycle clock: starting at 0:00

8. Warm up complete: start of the conditioning phase is 1:35 (see cycle graph – ‘A’ phase complete, start of ‘B’ phase)

9. Start Time of Pressurization: 2:40 (start of ‘C’ phase)10. Start Time of Sterilization: 3:14 (start of ‘D’ phase)11. Temp. / Press. & Time at start of sterilization (‘D’ phase).12- 17 Cycle pararmeters at 30 second intervals.18. Temp. Press. & Time of end of sterilization phase (end of D phase.)19. Time venting start 6:44 (start of E phase.)20. Sterilization was successfully completed.

7. The Communication Port

1. Statim 900J SJ00R6042. Unit # : OOO3. CYCLE NUMBER 000064. 16:10 04/12/20075. SOLID INSTRUMENTS6. 134 C for 3.5 min.7. CYCLE START 0:008. CONDITIONING 1:359. PRESSURIZING 2:4010. STERILIZING 3:1411. 136.5 C 227kPa 3:1412. 135.7 C 220kPa 3:4413. 136.4 C 226kP a 4:1414. 136.5 C 227kPa 4:4415. 135.9 C 221kPa 5:1416. 136.4 C 227kPa 5:4417. 135.9 C 221kPa 6:1418. 136.4 C 226kPa 6:4419. VENTING 6:4420. CYCLE COMPLETE 6:59

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1. Statim 900J SJ00R6042. Unit # : OOO3. CYCLE NUMBER 000064. 16:10 04/12/20075. SOLID INSTRUMENTS6. 134 C for 3.5 min.7. CYCLE START 0:008. CONDITIONING 1:359. PRESSURIZING 2:4010. STERILIZING 3:1411. 136.5 C 227kPa 3:1412. 135.7 C 220kPa 3:4413. 136.4 C 226kP a 4:1414. 136.5 C 227kPa 4:4415. 135.9 C 221kPa 5:1416. 136.4 C 227kPa 5:4417. 135.9 C 221kPa 6:1418. 136.4 C 226kPa 6:4419. VENTING 6:4420. CYCLE COMPLETE 6:59

8. Limited WarrantyFor a period of one year, SciCan Ltd. guarantees that the STATIM 900J, when manufactured by SciCan Ltd. in new and unused condition, will not fail during normal service due to defects in material and workmanship that are not due to apparent abuse, misuse, or accident. In the event of failure due to such defects during this period of time, the exclusive remedies shall be repair or replacement, at SciCan Ltd.’s option and without charge, of any defected part(s) (except gasket and filters), provided SciCan Ltd. is notified in writing within thirty(30) days of the date of such a failure and further provided that the defective part(s) are returned to SciCan Ltd. prepaid.This warranty shall be considered to be validated, if the product is accompanied by the original purchase invoice from the authorized SciCan Ltd. dealer, and such invoice identifies the item by serial number and clearly states the date of purchase. No other validation is acceptable. After one year, all SciCan Ltd.’s warranties and other duties with respect to the quality of the product shall be conclusively presumed to have been satisfied, all liability therefore shall terminate, and no action or breach of any such warranty or duty may thereafter be commenced against SciCan Ltd.

Any express warranty not provided hereon and any implied warranty or representation as to performance, and any remedy for breach of contract which, but for this provision might arise by implication, operation of law, custom of trade or course of dealing, including any implied warranty of merchantability or of fitness for particular purpose with respect to all and any products manufactured by SciCan Ltd. is excluded and disclaimed by SciCan Ltd. If you would like to learn more about SciCan Ltd. products and features, visit our website at www.scican.com.

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Machine Dimensions Length 384 mm (15.1 inches)

Width 293 mm (11.5 inches)

Height 282 mm (11.1 inches)

Chamber Size Length 190 mm (7.5 inches)

Width 90 mm (3.54 inches)

Height 53 mm (2.1 inches)

Reservoir Capacity Usable volume: 3.0 litres (102 fl.oz.)

Weight (Without water) 13 Kg / 29 lbs

Maximum Operating Pressure 49.5

Power Consumption 100 V, 50 / 60 Hz, 1200 W

9. Statim 900J Specifications

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