SciCan Statim 2000, StatIm 5000 User manual

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STAT

C a s s e t t e A u t o c l a v e ™

2000/5000

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• Operator’s Manual

Page 1

Manufactured by:

SciCan

1440 Don Mills Road, To r onto ON M3B 3P9 CANADA Phone: (416) 445-1600 Fax: (416) 445-2727 Toll free: 1-800-667-7733

Ta b l e of Contents

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

2. Important Information . . . . . . . . . . . . . . . . . . . . . . .4

2.1 Disclaimers

2.2 Statim 2000 — Unit Overview

2.3 Statim 5000 — Unit Overview

3. Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7

3.1 Environmental Considerations

3.2 Unit Placement

3.3 Connecting the Waste Bottle

3.4 Filling the Reservoir

3.5 Priming the Statim Pump

3.6 Language Selection

3.7 Preparing the Unit for Use

3.8 Shipping the Unit

4. Instructions for Use . . . . . . . . . . . . . . . . . . . . . . . .11

4.1 Statim 2000 — Using the cassette

4.2 Statim 5000 — Using the cassette

4.3 Statim 5000 — STAT-DRI Plates

4.4 Preparing and Loading Instruments

4.5 Instrument Mass Guide

4.6 Statim 2000 — Selecting a Cycle

4.7 Statim 2000 — Running a Cycle

4.8 Statim 5000 — Selecting a Cycle

4.9 Statim 5000 — Running a Cycle

4.10 Stopping a Cycle

5. Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28

5.1 Cleaning the Cassette

5.2 Cleaning the Reservoir

5.3 Cleaning the Exterior Surfaces

5.4 Changing the Statim 2000 Air Filter

5.5 Changing the Bacteria Retentive Air Filters

5.6 Replacing the Cassette Seal

5.7 Maintaining Fluid Levels

5.8 Preventative Maintenance Schedule

5.9 Spare Parts List

6. Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . .34

7. The Optional Statprinter . . . . . . . . . . . . . . . . . . . .37

7.1 The Statprinter

7.2 Installing the Statprinter

7.3 Setting Time and Date

7.4 Installing Paper into the Statprinter

7.5 Removing Paper Jams

8. Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41

9. Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . .42

9.1 Statim 2000 — Specifications

9.2 Statim 5000 — Specifications

Ta ble des matières

1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44

2. Informations importantes . . . . . . . . . . . . . . . . . . .45

2.1 Avertissements

2.2 Statim 2000 — Vue d’ensemble de l’appareil

2.3 Statim 5000 — Vue d’ensemble de l’appareil

3. Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48

3.1 Considérations environnementales

3.2 Mise en place de l’appareil

3.3 Branchement de la bouteille à eau résiduaire

3.4 Remplissage du réservoir

3.5 Amorçage de la pompe Statim

3.6 Sélection de la langue

3.7 Préparation de l’appareil pour utilisation

3.8 Expédition de l’appareil

4. Instructions d’utilisation . . . . . . . . . . . . . . . . . . . .52

4.1 Statim 2000 — Utilisation de la cassette

4.2 Statim 5000 — Utilisation de la cassette

4.3 Statim 5000 — Plaques STAT-DRI

4.4 Préparation et chargement des instruments

4.5 Guide des poids des instruments

4.6 Statim 2000 — Sélection d’un cycle

4.7 Statim 2000 — Exécution d’un cycle

4.8 Statim 5000 — Sélection d’un cycle

4.9 Statim 5000 — Exécution d’un cycle

4.10 Interruption de cycle

5. Entretien . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69

5.1 Nettoyage de la cassette

5.2 Nettoyage du réservoir

5.3 Nettoyage des surfaces extérieures

5.4 Changement du filtre à air Statim 2000

5.5 Changement des filtres à air retenant les bactéries

5.6 Remplacement du joint de cassette

5.7 Maintien des niveaux de liquide

5.8 Calendrier d’entretien préventif

5.9 Liste des pièces de rechange

6. Dépannage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75

7. Imprimante Statprinter en option . . . . . . . . . . . . .78

7.1 mprimante Statprinter

7.2 Installation de l’imprimante Statprinter

7.3 Réglage de l’heure et de la date

7.4 Installation du papier dans l’imprimante Statprinter

7.5 Élimination des bourrages du papier

8. Garantie . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82

9. Spécifications . . . . . . . . . . . . . . . . . . . . . . . . . . . .83

9.1 Statim 2000 — Spécifications

9.2 Statim 5000 — Spécifications

STATIM Cassette Autoclave is a registered trademark of SciCan.

STAT-DRI is a trademark of SciCan. All other trademarks referred to in this manual

are the property of their respec tive owners.

For all service and repair inquiries:

In Canada 1-800-870-7777 United States: 1-800-572-1211 International: (416) 446-4500 Email: techservice.ca@scican.com

Fabriqué par :

SciCan

1440 Don Mills Road, To r onto ON M3B 3P9 CANADA Tél. : (416) 445-1600 Télécop. : (416) 445-2727 Sans frais : 1-800-667-7733

STATIM Cassette Autoclave est une marque de commerce déposée de S ciCan.

STAT-DRI est une marque de commerce de SciCan. Toute autre marque de commerce

dont il est fait mention dans le présent manuel appartient à son propriétaire.

Pour toute demande de renseignements relatifs à l’entretien et aux réparations, contacter :

Au Canada : 1-800-870-7777 aux États-Unis : 1-800-572-1211 International : (416) 446-4500 Courrier électronique : techservice.ca@scican.c om

Congratulations on your selection of the STATIM Cassette Autoclave®. We are confident that you have purchased the finest equipment of its type. The Statim is a compact, counter-top unit that features a number of sterilizing cycles designed to meet your needs and suitability for steam sterilization.

The details of installing, operating and servicing your Statim are all contained within this operator

’

s manual. To ensure years of safe, trouble-free service, please read these instructions before operating this unit and keep them for future reference. Operational, maintenance and replacement instructions should be followed for the product to perform as designed. Contents of this manual are subject to change without notice to reflect changes and improvements to the Statim product.

The Statim is suitable for the sterilization of all types of dental and medical instruments designed to withstand steam sterilization. The Statim has not been designed to sterilize liquids, cloth loads, biomedical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave. For more information about instrument suitability for steam sterilization, consult the manufacturers’ reprocessing instructions.

Page 3

1. Introduction

STATIM 5000

STATIM 2000

Page 4

2. Important Information

2.1 Disclaimers

Use 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 steamprocess 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.

For additional information:

SciCan

1440 Don Mills Road, To r onto, ON M3B 3P9 CANADA Phone: (416) 445-1600 Fax: (416) 445-2727 Toll free: 1-800-870-7777

SciCan Medtech

Alpenstrasse 16, 6300 Zug SWITZERLAND Phone: (41-41) 727 -7027 Fax: (41-41) 727 -7029

EC Representative: BHT Hygienetechnik GmbH

Messerschmittstr. 11, D-86368 GERMANY

SciCan Inc.

500 Business Center Drive Pittsburgh, PA 15205 USA Phone: (412) 494-0181 Fax: (412) 494-4794 Toll free: 1-800-572-1211

US service information.

United States: 1-800-572-1211 International: (416) 446-4500

www.scican.com

Email: customer_servicecanada@scican.com

Email: techservice.ca@scican.com

The following symbols indicate:

2.2 Statim 2000 — Unit overview

When you receive your Statim 2000 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.

■

level indicator

■

keypad

■

reservoir cap

■

LCD

■

power indicator

■

active indicator

■

power switch

■

power cable port

■

leveler feet

■

exhaust tube port

■

compressor

■

cassette

■

biological filter

■

printer port (may not exist on all models)

Page 5

2. Important Information Cont’d.

A potential hazard to the operator.

A situation which may lead to a mechanical failure.

Important information.

START button.

Rubber and Plastics cycle button.

Caution Hot Surface.

Unwrapped cycle button.

Wrapped cycle button.

STOP button.

Air dry only button.

Power Indicator LED.

Active Indicator LED.

Cassette Lid and Tray

Unwrapped Instrument Rack

Waste Bottle and Bottle Lid fitting

Operator’s Manual / 10 Easy Maintenance Tips

Exhaust Tube

Stat Dri / Stat Dri Plus

Power Cord

Tu be Mounting Hardware

■

Figure 1

Page 6

2. Important Information Cont’d.

When you receive your Statim 5000 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.

■

level indicator

■

keypad

■

reservoir cap

■

LCD

■

power indicator

■

active indicator

■

power switch

■

power cable port

■

leveler feet

■

exhaust tube port

■

biological filter

■

optional printer

A potential hazard to the operator.

A situation which may lead to a mechanical failure.

Important information.

START button.

Rubber and Plastics cycle button.

Unwrapped cycle button.

Wrapped cycle button.

STOP button.

Heavy Duty Unwrapped Cycle Button.

Power Indiccator LED.

Active Indiccator LED.

Cassette Lid and Tray

Unwrapped Instrument Rack

Wrapped Instrument Rack

(Standard with N.A. models only)

Waste Bottle and Bottle Lid fitting

Tu be Mounting Hardware

STAT-DRI Plates

(Not standard with U.S. models)

■

Figure 2

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2.3 Statim 5000 — Unit overview

Caution Hot Surface.

Power Cord

Operator’s Manual / 10 Easy Maintenance Tips

Exhaust Tube

Stat Dri / Stat Dri Plus

The following symbols indicate:

3.1 Environmental Considerations

There 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 temperatures are 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

When placing the unit on a counter top, ensure the following :

•The level indicator bubble ■

on the front panel should be balanced in the front right quadrant of the target. This will ensure that the unit drains properly. Adjusting the three leveler feet will help you move the bubble if necessary.

•The unit should be stable and all four feet should be securely in contact with the counter surface. This will prevent the unit from moving freely.

Page 7

3. Installation

■

Figure 3

Page 8

3. Installation Cont’d.

3.3 Connecting the Waste Bottle

The waste bottle ■2is used to collect the wastewater after it has been converted to steam and then drained from the cassette. To connect the waste bottle to the Statim, follow these steps (see Figure 4):

1. Insert the exhaust tube

■

into the

fitting ■

on the back of the unit and push

firmly.

2. Cut the tube to length and slide the waste bottle fitting

■

into place.

3. Place the free end of the tube into the hole in the lid of the waste bottle and hand-tighten the fitting. Do not coil the exhaust tube.

4. Unscrew the lid and copper condenser coil

■

assembly from the waste bottle.

The lid and coil should come out together.

5. Fill the waste bottle with water to the MIN line and replace the lid and copper condenser assembly. Empty the waste bottle often to avoid unpleasant odors and discoloration of the contents. (A low-level chlorine-free disinfectant, prepared according to the manufacturer’s instructions, may be added to the waste bottle to remedy this situation). As a minimum, empty the waste bottle each time you refill the reservoir.

6. Place the waste bottle near the unit. We recommend that you keep it in a cabinet below the unit. The tube can be routed through a hole, (8 mm / 0.3" in diameter) in the counter-top and secured with the nylon clamps supplied.

3.4 Filling the Statim Reservoir

When filling the reservoir, ensure you only use steam processed distilled water containing less than 5ppm total dissolved solids (having conductivity of less than 10 µS/cm). The impurities and additives in other water sources will cause an error reading on the LCD. If you have a water conductivity meter (available from SciCan, order number 01-103139S) check each new water container before filling the reservoir. To fill the reservoir, follow these steps (see Figure 5):

■

Figure 4

■

2000

■

5000

■

1. Remove the reservoir cap ■

2. Pour steam-process distilled water

into the reservoir until almost full (a maximum of 4 L / 1 U.S. gal.) Use a funnel to avoid spillage.

3. Replace the cap.

3.5 Priming the Statim Pump

To prime the Statim pump, follow these steps (see Figure 6):

1. Move the unit to the edge of the work surface. The front leveler feet should be

approximately 12 mm / 0.5" from the edge.

2. Lift the front left corner of the unit upward and remove the drain tube ■

from the clip

located on the underside of the unit.

3. Pull the drain tube outward so the free end can be positioned over a water container.

4. Fill the reservoir with steam-process distilled water.

5. Remove the plug

■

from the end of the drain tube and allow water to drain from the tube into a container. When the water flows in a steady stream, replace the stopper.

6. Lift the front left corner of the unit upward and reinsert the tube into the clip on the underside of the unit. Push the excess length of tubing back into the space provided.

Make sure the plug in the drain tube is secured.

After installation and before sterilizing any instruments, run two Wrapped Cycles. For further instruction, see Section 3.7 Prepairing the unit for use.

3.6 Language Selection

The messages displayed on the LCD can be changed to a number of different languages. To change the current language selection, follow these steps:

1. Turn the power switch at the back of the unit OFF.

2. For the Statim 2000 press and hold the Wrapped Cycle button. For the Statim 5000 press and hold the Unwrapped Cycle button.

3. While depressing the appropriate button, turn the power switch at the back of the unit to ON.

Page 9

3. Installation Cont’d.

■

Figure 5

Figure 6

■

Page 10

3. Installation Cont’d.

4. Use the Unwrapped or Wrapped cycle buttons to scroll through language selections.

5. When the desired language is displayed, press the STOP button to save the

selection and return to the regular operating mode.

3.7 Preparing Unit for Use

Once the unit is installed and before any instruments are sterilized, run two Wrapped Cycles (see Sections 4.7 Statim 2000 — Running a Cycle and 4.9 Statim 5000 — Running a Cycle). Remove the cassette once it has cooled. Clean the top (lid) and bottom (tray) sections using a soft cloth to wipe the inside surfaces and then rinse thoroughly with tap water. Once the cassette is clean and dry, coat the inside surfaces with Stat-Dri.

3.8 Shipping the Unit

Before you move the unit, you will need to drain the reservoir. To do so, follow these steps:

1. Place a water container below the unit.

2. Using the drain tube (see Section 3.5 Priming the Pump, Figure 6) empty the contents of the reservoir into the water container.

3. Remove any remaining water from the reservoir with a non-linting absorbant towel.

4. Screw-in the three leveler feet found underneath the unit.

5. Repack the unit in the original packing materials and include all accessories originally included with the unit.

6. Specify heated and insured shipping.

4.1 Statim 2000 — Using the Cassette

When removing the cassette after a cycle, exercise caution as the metal areas will be hot and the cassette may contain hot steam.

•To open the cassette:

1. Hold the cassette handle with your thumbs facing inward on the cassette latch.

2. Push downward on the cassette latch.

3. Raise the cassette lid upwards and disengage

the hinge.

4. Rest the lid on its outer surface.

•To close the cassette:

1. Align the hinge tab on the cassette lid with

the hinge slot on the rear of the bottom tray.

2. As you begin to close the lid, the hinge tab and slot will engage.

•Inserting the cassette into the Statim 2000:

1. Place the end of the cassette into the unit.

2. Gently push inward until you hear a “click

”

sound.

Never push the cassette into the Statim with force as the interior components could be damaged.

•Removing the cassette:

1. Grasp the handle with two hands and pull away from the unit.

2. Pull the cassette clear of the unit and set down on a firm surface.

•Disengaging the cassette

When not in use, the cassette should be disengaged. To disengage the cassette, grasp the handle and pull the cassette out until there is a 15 mm to 20 mm (

/2" to 3/4") gap

between the front of the Statim 2000 and the cassette handle.

•STAT-DRI /STAT-DRI PLUS

Tr e a t m ent of the interior surfaces of the cassette with the Stat-Dri / Stat-Dri Plus drying agent, provided with your unit, will enhance the drying process. (Replacement bottles are available from SciCan, order number 2OZPLUS, 8OZPLUST, 32OZPLUS).

Page 11

4. Instructions For Use

Figure 7

cassette latch

Page 12

4. Instructions For Use Cont’d.

4.2 Statim 5000 — Using the Cassette

When removing the cassette after a cycle, exercise caution as the metal areas will be hot and the cassette may contain hot steam.

•To open the cassette:

1. Push the carry handle ■

into the open

position.

2. Put your hands on either side of the cassette handle.

3. Insert your forefingers in the slots and place your thumbs on the thumb pads.

4. Press down with your thumbs and pull up with your forefingers until the lid opens.

5. Raise the cassette lid and disengage from the tray. Rest the lid on the outer surface.

•To close the cassette:

1. Align the hinge tab on the lid with the hinge slot on the tray.

2. As you begin to close the lid, the hinge tab and slot will engage.

3. Place the carry handle into the closed position.

•Inserting the cassette into the Statim 5000:

1. Hold the cassette handle in one hand and the carry handle in the other as shown in the diagram.

2. Place the end of the cassette into the unit and drop the carry handle into its closed position.

3. Gently push the cassette inward until you hear a click sound.

Never push the cassette into the Statim with force as the interior components could be damaged.

Figure 8

■

•Removing the cassette:

1. Grasp the cassette handle with one hand and pull out from the unit.

2. As the cassette emerges from the unit, grasp the carry handle with your free hand

and lift it upwards.

3. Pull the cassette clear from the unit and set down on a firm surface.

•Disengaging the cassette

When not in use, the cassette should be disengaged. To disengage the cassette, grasp the handle and pull the cassette out until there is a 15 mm to 20 mm (

/2" to 3/4") gap

between the front of the Statim 5000 and the cassette handle.

4.3 Statim 5000 — STAT-DRI Plates

The Statim 5000 cassette uses STAT-DRI plates to enhance the drying process for wrapped instruments. The adjustable plates are designed for the unwrapped instruments rack and eliminate the need for a separate wrapped instrument rack. Up to ten plates can be arranged either along the length of the rack or across the rack. With the exception of the U.S. model, each unit is shipped with five STAT-DRI plates. Additional plates may be ordered from SciCan (SciCan part number 01-103935). To install and adjust a STAT-DRI plate, follow these steps:

1. Hold a plate in the desired orientation, tilted slightly

forward with the tabs down.

2. Insert the tabs between the mesh of the

unwrapped instrument rack.

3. Each tab has an elongated slot. Slide the plate

until the wire is at the end of each slot.

4. Release the plate to the resting position.

5. Prepare and load instruments for sterilization.

4.4 Preparing and Loading Instruments

Before 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 cassette, and the Statim. Lubricated instruments must be wiped thoroughly and any excess lubricant should be removed before loading.

Page 13

4. Instructions For Use Cont’d.

Figure 9

Page 14

4. Instructions For Use Cont’d.

•Unwrapped Instruments

Arrange unwrapped instruments on the instrument rack in the tray so that they do not touch one another. This ensures that steam reaches all surfaces and will promote drying.

Instruments must not be stacked or piled in the cassettes, as this will impede the sterilization process.

•Wrapped Instruments

Place the instruments into autoclave bags according to the manufacturer's instructions. Orient the instrument rack in the cassette to ensure that wrapped instruments rest approximately 6 mm (0.25 ") above the cassette base. Place the wrapped instruments on the rack and arrange them to avoid overlap. Ensure that all wrapped loads are dry before handling and /or storage to maintain sterility.

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.

The wrapped instrument rack for the Statim 5000 is designed to hold a maximum of 12 autoclave bags. Care must be taken to ensure that the combined weight of the loaded bags does not exceed 1.5 kg (3.3 lbs).

The Unwrapped instrument rack fitted with a maximum of 10 Stat-Dri plates will hold 10 autoclave bags.

•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 tray, leave a space between the instruments and the cassette walls. This ensures that steam reaches all surfaces, and will promote drying.

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.

Page 15

4. Instructions For Use Cont’d.

•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 until the air-dry phase is complete.

Best Practice: Allow instruments (wrapped or unwrapped) to dry completely prior to handling. In order to promote drying and enable effective sterilization, wrapped or pouched instruments must not touch each other.

•Note for Ophthalmology Use

In the field of ophthalmology, proper wrapping or pouching of surgical instruments will reduce the exposure of instruments to any process residues during the sterilization cycle. Due to the highly sensitive nature of some types of surgery (particularly in ophthalmology), SciCan recommends that all instruments be routinely packaged or wrapped and processed through the wrapped cycle of the sterilizer. This practice is the suggested approach for the majority of sterile surgical procedures and is referenced in most leading infection control publications and guidelines.

•Routine Monitoring

Chemical process indicators suitable for steam sterilizers should be included in or on each package or load being sterilized. In addition, the weekly use of biological indicators, which allow you to ascertain whether the instruments have been exposed to sterilization conditions, is recommended. For Statim 5000 units in the United States, SciCan recommends using the 3M Attest™ biological monitoring system for routine monitoring. This system consists of self contained biological indicators and incubators. It is important to select the correct biological indicator for the cycle being tested.

Page 16

4. Instructions For Use Cont’d.

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 u s e the indicators with the Statim, follow these steps:

1. Place the appropriate biological indicator in the Statim 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 cassette 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 and contact your SciCan dealer for further assistance.

Because the turnaround time for the 3M AttestTMis 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.

4.5 Instrument Mass Guide

Instrument

Scissors Dental scalers Forceps Dental handpiece Wrapped Instrument rack Unwrapped instrument rack Suction cannula Plastic mouth mirror Impression tray Plastic x-ray positioning ring

Ty p i c a l Instrument Mass

30 g (0.96 ozt) 20 g (0.64 ozt) 15 g (0.48 ozt) 40 to 60 g (1.3 ozt to 1.9 ozt) 260 g (8.36 ozt) 225 g (7.23 ozt) 10 g (0.32 ozt) 8 g (0.3 ozt) 15 to 45 g (0.48 ozt to 1.5 ozt) 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.

4.6 Statim 2000 — Selecting a Cycle

The Statim 2000 has three sterilization cycles, each designed to sterilize a specific type of instrument. The instruments will remain sterile after a successful cycle until the cassette is removed from the autoclave. At the end of each sterilization cycle, microbiologically filtered air-drying will commence for 1 hour. Air-drying can be interrupted at any time.

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 until the air-dry phase is complete.

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

4.5 for information on how to make up an appropriate load for the masses specified for individual cycles.

1. Unwrapped Cycle

The Unwrapped Cycle is a general purpose sterilization cycle used to sterilize up to 1.0 kg (2.2 lbs) of solid metal instruments such as pliers, burrs, scalers and forceps. Dental handpieces may be sterilized in this cycle.

To s elect the Unwrapped Cycle, press the Unwrapped Cycle button, then press the START button.

The sterilization temperature in the cassette is 135 ˚C (275 ˚F) and the holding time is 3.5 minutes. See Section 4.1 Statim 2000 — Using the Cassette and Section 4.4 Preparing and Loading Instruments before running this cycle.

*See the chart at the end of section 4.7 Statim 2000 - Running a Cycle for a complete list of cycle time and temperature listings in different countries.

Page 17

4. Instructions For Use Cont’d.

135˚C

(275˚F)

100˚C

(212˚F)

A B Conditioning C Pressurizing

War ming up

3.5 MIN.*

D Sterilizing E Ven t ing F Air Drying

Page 18

4. Instructions For Use Cont’d.

2. Wrapped Cycle

The Wrapped Cycle is used to sterilize up to 1.0 kg (2.2 lbs) of solid and hollow metal instruments which have been sealed in paper / paper, or paper / plastic autoclave bags. Dental handpieces may be sterilized in this cycle.

To s elect the Wrapped Cycle, press the Wrapped Cycle button, then press the START button.

The sterilization temperature in the cassette is 135˚C (275˚F) and the holding time is 10 minutes. See Section 4.1 Statim 2000 — Using the Cassette and Section 4.4 Preparing and Loading Instruments before running this cycle.

If wrapped instruments are intended for storage, the wraps must be dry when the cassette is removed from the unit and opened.

3. Rubber and Plastics Cycle

The Rubber and Plastics Cycle is used to sterilize up to 0.4 kg (0.9 lbs) of solid unwrapped instruments constructed of metal or the materials listed in Section

4.4 Preparing and Loading Instruments.

To s elect the Rubber and Plastics Cycle, press the Rubber and Plastics Cycle button, then press the START button.

The sterilization temperature in the cassette is 121˚C / 250˚F and the holding time is 15 minutes.

*See the chart at the end of section 4.7 Statim 2000 - Running a Cycle for a complete list of cycle time and temperature listings in different countries.

135˚C

(275˚F)

100˚C

(212˚F)

A B Conditioning C Pressurizing

War ming up

10 MIN.

D Sterilizing E Ven t ing F Air Drying

121˚C

(250˚F)

100˚C

(212˚F)

A War ming up B Conditioning C Pressurizing

15 MIN.*

D Sterilizing E Ven t ing F Air Drying

4. Air Dry Only Cycle This is not a sterilization cycle.

The Air Dry Only Cycle starts automatically after each sterilizing cycle and runs for 60 minutes.

Air drying may be interrupted by pressing the STOP button. To ensure that the contents of the cassette are dry, the cycle should run for the full 60 minutes. Dryness is important for unwrapped instruments for corrosion prevention. For wrapped instruments, a dry wrap is required to maintain sterility.

If the STOP button is pressed during the air drying stage of the sterilization cycle, and the cassette has not been removed from the autoclave, the Air Dry Only cycle may be used to promote further drying. If the cassette has been removed from the autoclave, it may NOT be reinserted for the Air Dry Only cycle. If the cassette contains wrapped instruments and the wraps are not dry when the cassette is opened, the instruments must be used immediately or resterilized.

To start, press the Air Dry Only cycle button, then press the START button.

When started independently, this cycle will run for 1 hour.

Page 19

4. Instructions For Use Cont’d.

Page 20

4. Instructions For Use Cont’d.

4.7 Statim 2000 — Running a Cycle

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

14:23 3/11/2001 SELECT A CYCLE

SELECT A CYCLE

PRESS START

WARMING UP

UNWRAPPED

135˚C for 3.5 min*.

WRAPPED

135˚C for 10 min.

RUBBER AND PLASTICS 121˚C for 15 min*.

Tu r n t h e p o wer switch at the back of the unit to ON. The LCD Display reads:

(if optional printer is installed)

Press the appropriate cycle button on the keypad.

The display will read either:

* See the chart at the end of section 4.7 Statim 2000 Running a Cycle for a complete list of cycle time and temperature listings in different countries.

As the button is released the display reads:

The amber indicator light comes on to indicate that the cycle is in progress. During the cycle, the phases of the cycle will be displayed and the messages will appear similar to:

[

CYCLE YOU SELECTED

]

[

CYCLE YOU SELECTED

]

95˚C

130˚C

135˚C 212kPa 3:30

105˚C

CONDITIONING

PRESSURIZING

STERILIZING

VENTING

As the cycle is running an intermittent buzzing sound will be apparent as the pump injects water into the steam generator. A random clicking sound will also be heard as the exhaust valve opens and closes.

Once the sterilization cycle is complete, a reminder tone will sound and the amber light will flash as the cycle moves into the Air Drying phase.

The buzzing noise during the air drying stage is the compressor operating. The air drying phase of the cycle may be interrupted at any time by pressing the STOP button. The display will appear similar to:

[

CYCLE YOU SELECTED

]

REMOVE CASSETTE

When the automatic 60 minute air drying stage is finished the display reads:

[

CYCLE YOU SELECTED

]

CYCLE COMPLETE

If a sterilization cycle is successful the reminder tone sounds and the amber light flashes until the STOP button is pressed or the cassette is removed from the unit.

If a message is displayed which gives a CYCLE FAULT code or a NOT STERILE message, the cassette contents are not sterile. See Section 6. Troubleshooting for more information.

* Statim 2000 Cycle Time, Temperature, and Model Listing

Page 21

4. Instructions For Use Cont’d.

Country Model no.

Unwrapped Wrapped Rubber & Plastics

Te m p Time Temp Time Temp Time

Czech 01-122328 135˚C 4 min. 135˚C 10 min. 121˚C 20 min.

275˚F 275˚F 250˚F

Canada (and all All other 135˚C 3.5 min. 135˚C 10 min. 121˚C 15 min.

other Countries)

models

275˚F 275˚F 250˚F

Page 22

4. Instructions For Use Cont’d.

4.8 Statim 5000 — Selecting a Cycle

The Statim 5000 has four sterilization cycles, each designed to sterilize a specific type of instrument. It is important not to overload the chamber as this can inhibit steam access to all instrument surfaces. The instruments will remain sterile after a successful cycle until the cassette is removed from the autoclave housing. At the end of each sterilization cycle, microbiologically filtered air-drying will commence for 1 hour. Airdrying can be interrupted at any time.

The types of instruments, sterilization requirements, and graphs depicting each cycle are described on the next few pages. Consult the Instrument Mass Guide in section 4.5 for information on how to make up an appropriate load for the masses specified for individual cycles.

Please note that not all cycle times are standard with all units. See the chart at the end of Section 4.9 Running a Cycle for a complete list of all Statim 5000 cycle times and temperatures.

Page 23

4. Instructions For Use Cont’d.

1. Unwrapped Cycle

The Unwrapped Cycle is used to sterilize light loads (less than 0.5 kg or 1.1 lbs) of solid metal instruments such as pliers, burrs, scalers, and forceps.

To s elect the Unwrapped Cycle, press the Unwrapped Cycle button, then press the START button. The sterilization temperature in the cassette is 135˚ C* (275˚ F*) and the holding time is

3.5 minutes*. See Section 4.2 Statim 5000 — Using the Cassette and Section 4.4 Preparing and Loading Instruments before running this cycle.

See the chart at the end of Section 4.9 Statim 5000 — Running a Cycle for a complete list of cycle time and temperature unit listings in different countries.

2. Wrapped Cycle

The Wrapped Cycle is used to sterilize up to

1.5 kg (3.3 lbs) of solid and hollow metal instruments which have been sealed in paper / paper, or paper / plastic autoclave bags. Dental hand pieces may be sterilized in this cycle.

To s elect the Wrapped Cycle, press the Wrapped Cycle button, then press the START button. The sterilization temperature in the cassette is 135˚ C* (275˚ F*) and the holding time is 6 minutes*. See section 4.2 Statim 5000 — Using the Cassette and Section 4.4 Preparing and Loading Instruments before running this cycle.

See the chart at the end of Section 4.9 Statim 5000 — Running a Cycle for a complete list of cycle time and temperature unit listings in different countries.

If wrapped instruments are intended for storage, the wraps must be dry when the cassette is removed from the unit and opened.

*135˚C

(*275˚F)

100˚C

(212˚F)

Warming up

B Conditioning C Pressurizing

3.5 MIN.* D Sterilizing E Ve nt ing F Air Drying

*135˚C

(*275˚F)

100˚C

(212˚F)

Warming up

B Conditioning C Pressurizing

6 MIN.* D Sterilizing E Ve nt ing F Air Drying

Page 24

3. Rubber and Plastics Cycle

The Rubber and Plastics Cycle is used to sterilize up to 0.4 kg (0.9 lbs) of solid or hollow unwrapped instruments constructed of metal or the materials listed in Section 4.4 Preparing and Loading Instruments.

To s elect the Rubber and Plastics Cycle, press the Rubber and Plastics Cycle button, then press the START button. The sterilization temperature in the cassette is 121˚C (250 ˚C) and the holding time is 15 minutes*.

See the chart at the end of Section 4.9 Statim 5000

— Running a Cycle for a complete list

of cycle time and temperature unit listings in different countries.

4. Heavy Duty Unwrapped Cycle

The Heavy Duty Cycle is used to sterilize larger loads of unwrapped metal instruments weighing up to 1.5 kg (3.3 lbs). Dental hand pieces can be sterilized in this cycle.

To s elect the Heavy Duty Unwrapped Cycle, press the Heavy Duty Unwrapped Cycle button, then press the START button.

See the chart at the end of section 4.9 Statim 5000

— Running a Cycle for a complete list of

cycle time and temperature unit listings in different countries.

4. Instructions For Use Cont’d.

121˚C

(250˚F)

100˚C

(212˚F)

A B Conditioning C Pressurizing

Warming up

15 MIN.*

D Sterilizing E Venting F Air Drying

*135˚C

(*275˚F)

100˚C (212˚F)

Warming up

B Conditioning C Pressurizing

6 MIN*

D Sterilizing E Ve nt ing F Air Drying

Page 25

4. Instructions For Use Cont’d.

4.9 Statim 5000 — Running a Cycle

See the chart on the end of section 4.9 Statim 5000 — Running a Cycle for a complete list of cycle time and temperature unit listings in different countries. To operate each cycle, follow these steps and watch the LCD.

14:23 3/11/2001 SELECT A CYCLE

SELECT A CYCLE

PRESS START

65˚C WARMING UP

Tu r n t h e p o wer switch at the back of the unit to ON. The LCD Display reads:

(if optional printer is installed)

Press the appropriate cycle button on the keypad.

The display will read either:

As the button is released the display appears similar to:

The amber indicator light comes on and the display will appear similar to:

[

CYCLE YOU SELECTED

]

[

CYCLE YOU SELECTED

]

110˚C

130˚C

135˚C 212 kPa 3:30

105˚C

CONDITIONING

PRESSURIZING

STERILIZING

VENTING

UNWRAPPED 135˚C for 3.5min.*

WRAPPED 135˚C for 6 min.*

RUBBER AND PLASTICS 121˚C for 15 min.*

HEAVYDUTY UNWRAPPED 135˚C for 6 min.*

As the cycle progresses, the cycle stage and temperature of the chamber are displayed. During sterilization, the pressure of the chamber and the time remaining for that stage is also displayed. During the air drying phase, the time remaining is displayed.

* See the chart on the end of section 4.9 Statim 5000Running a Cycle for a complete list of cycle time and temperature unit listings in different countries.

Page 26

4. Instructions For Use Cont’d.

The sterilizing cycle ends when the reminder tone sounds, the amber light flashes and the message CYCLE COMPLETE is displayed. The display appears similar to:

AIR DRYING 60:00 CYCLE COMPLETE

Yo u may interrupt the automatic 60 minute Air Drying phase at any time, or let it run to the end. To ensure that Wrapped Instrument loads are dry, allow this cycle to run to be completed. Instruments in wrapped packs should be considered non-sterile if removed before the end of the drying phase.

To r em o ve t he cassette, you must first press the button on the keypad.

The display appears similar to:

PLEASE WAIT

CYCLE COMPLETE

Be careful. The metal parts will be hot, and the cassette will contain hot steam. After the cassette is removed from the unit, it should be opened to hasten drying of unwrapped instruments.

If the Air Drying phase is not interrupted, the program will automatically continue to run. When this phase ends, the display reads:

REMOVE CASSETTE

CYCLE COMPLETE

When a sterilization cycle is successful, the reminder tone sounds and the amber light flashes until the STOP button is pressed or the cassette is removed from the unit.

If a message is displayed which gives a CYCLE FAULT code or a NOT STERILE message, the cassette contents may not be sterile. See Section 6. Troubleshooting for more information.

* Statim 5000 Cycle Time, Temperature, and Model Listing

Country Model no.

Unwrapped Wrapped Rubber & Plastics Heavy Duty Unwrapped

Te m p Time Temp Time Temp Time Temp Time

USA 01-201103(-R) 132˚C 3.5 132˚C 6 121˚C 35 132˚C 6

01-201104(-R) 270˚F min. 270˚F min. 250˚F min. 270˚F min.

Czech 01-202327 135˚C 4 135˚C 10 121˚C 20 135˚C 18 Republic

01-202328 275˚F min. 275˚F min. 250˚F min. 275˚F min. 01-212328

Canada

(and all All other 135˚C 3.5 135˚C 6 121˚C 15 135˚C 6

other Countries)

models

275˚F min. 275˚F min. 250˚F min. 275˚F min.

Page 27

4. Instructions For Use Cont’d.

4.10 Stopping a Cycle

To s t o p a cycle press the STOP button. If the stop button is pushed, the cassette is removed, 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 STOP button must be pressed before another cycle can be started. The display reads any of the following messages:

CYCLE FAULT # #

NOT STERILE

CASSETTE REMOVED

NOT STERILE

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

If the air drying stage of the cycle is interrupted, do not store wrapped instruments that were in the cassette unless they are dry.

Page 28

5. Maintenance

5.1 Cleaning the Cassette

Keeping the Statim cassette clean is good clinical practice and assists in the function of the unit. SciCan recommends that the interior surface be cleaned at least once a week. Use dishwashing soap or a mild detergent that does not contain chlorine. Scrub the inside of the cassette with a cleaning pad designed for use with Teflon™ coated surfaces. After scouring, rinse thoroughly with water to remove all traces of the detergent. Cleaning the inside of your cassette is very important if you regularly sterilize lubricated instruments. Coating the entire inside surface with STAT-DRI / STAT-DRI PLUS drying agent induces water to form an even coat on the inside surface, without beading. The water in contact with the hot cassette surfaces also evaporates much more efficiently. Spotting is minimized and instruments dry much better. STAT-DRI / STAT-DRI PLUS should be applied every 10 cycles, and after every cassette cleaning.

5.2 Cleaning the Reservoir

Check the reservoir for dirt or particles. The reservoir may be cleaned by draining followed by cleaning and rinsing with steam process distilled water ONLY. Use of chemicals or cleaning agents is not reccommended and could cause the unit damage.

5.3 Cleaning the Exterior Surfaces

Use a soft cloth moistened with soap and water to clean all exterior surfaces. Do not use harsh cleaning chemicals or disinfectants.

5.4 Changing the Statim 2000 Air Filter

The filter should be replaced every six months in order to maintain an adequate supply of clean air during the air drying cycle.

To c hange the filter, follow these steps:

1. Turn the power switch at the back of the unit OFF.

2. Remove and discard the old foam air filter

■

3. Install the new filter ■

(SciCan part no. 01-100207S).

4. Secure the filter plate ■2to the back of the compressor using the screw ■1retained during the disassembly procedure.

■

Figure 10

2000

Page 29

5. Maintenance Cont’d.

5.5 Changing the Bacteria Retentive Air Filters

The filters should be replaced every six months or after 500 cycles to maintain an adequate supply of clean air during the air drying cycle.

To c hange the bacteria retentive air filter on the Statim 2000 and 5000, follow these steps:

1. Power the Statim OFF.

2. Disconnect tube A

■

from the bacteria

retentive filter

■

and remove the filter

from the filter bracket

■

. As you remove the filter from the bracket, note the orientation of the arrow mark on the filter.

3. When the filter is free of the bracket, carefully disconnect tube B

■

from

the filter.

4. Before installing the replacement bacteria retentive filter

■

(SciCan order no. 01-102119S) check that the arrow mark on the filter matches the direction of the arrow on the bracket. Push the left hand filter fitting into tube B

■

5. Gently press the replacement filter into the filter bracket

■

. The arrow mark of

the filter should be facing out and pointing to the left.

6. Re-connect tube A

■

to the right hand filter fitting.

5.6 Replacing the Cassette Seal

To ensure optimum performance of your Statim cassette autoclave, change the cassette seal every 500 cycles or every six months, whichever comes first. Replacement seals are available from SciCan (order number 01-100028S for Statim 2000 and 01-101649S for Statim 5000).

When replacing the cassette seal, the cassette channel must be flushed with distilled water. The old seal is removed, the cassette channel is flushed with distilled water and then followed by replacement with the new seal.

Figure 12

■

5000

Figure 11

■

2000

Page 30

5. Maintenance Cont’d.

To c hange the cassette seal, follow these steps:

Place the cassette lid and the new seal on a clean work surface. Examine the position of the old seal in the cassette lid and arrange the new seal in the same orientation, next to the lid.

Remove the old seal and discard. Clean any residue out of the seal channel and flush out the channel with distilled water.

Lubricate the new seal with the liquid seal lubricant provided.

Insert the rounded edge of the seal under the round lip of the lid. Align the holes in the new seal with the holes in the lid.

NOTE: At every corner, two square nibs should be visible.

Ensure the seal is completely inserted. Feel around the periphery to ensure the seal is securely in place.

NOTE: During a cycle, steam may appear between the lid and the tray. If this persists, remove the cassette and check that the seal is correctly installed.

Be careful. The metal parts will be hot, and the cassette may contain hot steam.

5.7 Maintaining Fluid Levels

Use only steam-process distilled water containing less than 5 ppm total dissolved solids (having conductivity of less than 10 µS/cm) in the Statim. To fill the reservoir, remove the cap from the top of the unit and fill the reservoir. We recommend using a funnel to minimize spills. Each time you refill the reservoir, empty the waste bottle and refill with water to the MIN line. Empty the waste often to avoid unpleasant odors and discoloration of the contents. (A low-level chlorine-free disinfectant, prepared according to the manufacturer’s instructions, may be added to the waste bottle to remedy this situation).

5.8 Preventative Maintenance Schedule

To 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.

Figure 13

Page 31

5. Maintenance Cont’d.

Te c h n ician

Once a year

Cassette

Air Filters

Check the tray, lid and seal for damage. Replace if necessary.

Check the filters. Replace if dirty.

Solenoid Valve

Inspect the valve and clean if dirty. Replace the plunger if defective.

Calibration

Calibrate the unit.

Pump

Clean the filters, replace if dirty.

Check Valve

Remove the air compressor tube from the check valve inlet while running a cycle. Make sure no steam is leaking from the valve. Replace if there are any leaks.

Water Reservoir

Check the reservoir for dirt. Clean and rinse with steam process distilled water if necessary.

Operator

Daily

Cassette

Wash the interior of the cassette with chlorine-free dishwashing detergent or soap. Rinse thoroughly with water.

Unit

To e n sure optimal performance of the Statim autoclave, SciCan recommends that a full sterilization cycle, which must include the full Air Drying phase, be completed at the end of each day of use. This is especially important when the unit is left idle over the weekend or for any extended period of time.

Weekly

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.

Every six months

Air Filter

Replace every 500 cycles or six months (whichever comes first).

Biological Air Filter

Replace every 500 cycles or six months (whichever comes first).

Cassette Seal

Replace every 500 cycles or six months (whichever comes first).

Air Filter

Check the air filter for dirt and moisture. Replace if dirty. Call for service if wet.

Water Reservoir

Drain Daily

Biological Air Filter

Check the air filter for dirt and moisture. Replace if dirty. Call for service if wet.

The schedules below describes the necessary actions.

Page 32

5. Maintenance Cont’d.

5.9 Spare Parts List

01-100780S

Bumper

01-100782S

Push-in Fitting, (2000)

01-101658S

Cassette Handles, (5000)

01-101755S

Push-in Fitting, (5000)

01-106030S

Cassette Lid Handle, (2000)

01-104472

Extended cassette Handles

01-100008A

Kit Cassette Final (2000)

01-100028S

Cassette Seal, (2000)

01-100204S

Exhaust Tube, (2000 & 5000)

01-100207S

Compressor Filter

01-100271A

Kit Tray Cassette w/Mesh, Box Stat1

01-100572S

Power Cord North America, (2000)

01-100584S

Power Cord German, (2000)

01-100585S

Power Cord Italian, (2000)

01-100586S

Power Cord U.K., (2000)

01-100612S

English Manual/Tubing/Indicators, (2000)

01-100724S

Condenser Bottle w/o Condenser, (2000 & 5000)

01-100730S

Power Cord Japan, (2000)

01-100735S

Waste Water Bottle Fitting, (2000 & 5000)

01-100783S

Kit Filler Cap Replacement Eng.

01-100799S

Power Cord Switzerland, (2000)

01-100812S

Condenser Bottle, (2000 & 5000)

01-100834S

Cassette Lid, (2000)

01-101553S

Leveler, (2000 & 5000)

01-101613S

Cassette Complete with Box, (5000)

01-101614S

Tr ay C o mp lete with Box, (5000)

01-101647S

Power Cord North America, (5000)

01-101649S

Cassette Seal, (5000)

01-101652S

Air Compressor Filter, (5000)

01-101657S

Thermal Paper (Box of 10 rolls)

01-101709S

Mesh Rack, (5000)

01-101757S

Cassette Lid w/Box, (5000)

01-101763S

Power Cord Japan, (2000 & 5000)

01-101766S

Power Cord UK, (2000 & 5000)

01-101767S

Power Cord Australia, (5000)

01-101768S

Power Cord Switzerland, (2000 & 5000)

01-101769S

Power Cord Italy, (2000 & 5000)

01-101779S

Power Cord Europe, (2000 & 5000)

01-101783S

Reservoir Cap, (2000 & 5000)

01-101787S

Filler Cap (Demo), (2000 & 5000)

01-101970S

Data Cable, (5000 and STATprinter)

01-102054S

Rack-Wrapped Instruments, (5000)

01-102119S

Filter Biological, (2000 & 5000)

01-103139S

Conductivity Meter, (2000 & 5000)

01-103475S

Tr ay, (2000)

01-103555S

Power Cord Replacement Denmark

01-103557S

Power Cord Replacement Denmark (detached)

01-103865S

Seal Lubricant, (2000 & 5000)

01-103923

Condenser Additional Bottle

01-103935

STATDRI Plates, (5000)

01-103945S

Rack-Tray Unwrapped Instrument Kit, (2000)

01-104093S

Exhaust Tube 3m Long

01-104104

Extended Length Cassette, (5000)

01-104284S

Biological Filter Bracket, (2000 & 5000)

01-104337S

Extended Evaluation Cassette, (5000)

01-104343S

Plug - Drain Tubing, (5000)

01-104499

Extended Cassette Instrument Rack, (5000)

01-104785S

Instrument Holder - 10 mm, (5000)

01-104786S

Instrument Holder - 4 mm, (5000)

01-101974

STATprinter

Page 33

5. Maintenance Cont’d.

01-106071S

Extended Cassette Lid Handle, (5000)

01-106325

Container Endoscope Complete

01-106438S

Cassette Lid, Extended

01-106653

Mesh Tray, (2000)

01-106938S

Operator’s Manual ST-2000/5000, (2000 & 5000)

01-107767S

Extended Tray, (5000)

01-108262S

Basket Medical, (2000)

01-108263S

Basket Medical, (5000)

01-210000

Kit Printer, (5000)

2OZPLUS

STAT-DRI Plus 2 oz. Bottle w/sprayer

32OZPLUS

STAT-DRI Plus 32 oz. Bottle w/sprayer

8OZPLUS

STAT-DRI Plus 8 oz. Bottle w/cap

99-108332

Chemical Emulator 134˚C, 3.5 min.

Page 34

6. Troubleshooting

Problem

Unit does not power ON.

There is water under the machine.

Instruments do not dry.

Check that water was not spilled when refilling the reservoir. Make sure the plug in the drain tube is secured. Remove and reinsert the cassette . Attempt another cycle.

Be careful. The metal parts will be hot, and the cassette will contain hot steam.

The cassette is leaking. If water drips from the underside of the unit during operation, check the cassette seal for misalignment or damage and replace the seal if required.

Be careful. The metal parts will be hot, and the cassette will contain hot steam.

Attempt another cycle. If it still leaks attempt another cycle using a different cassette if possible.

If the leak persists, turn the unit OFF, remove and unload the cassette, unplug the unit, and call your dealer.

Best drying occurs when the cycle continues to completion. Allow the cycle to finish. Make sure the instruments are loaded correctly in the cassette. Refer to section 4.4 Preparing and Loading Instruments.

Check the unit leveling.

Check air filters and replace if dirty.

Clean the inside of the cassette and treat with Stat-Dri / Stat-Dri Plus drying agent. Refer to section 5.1 Cleaning the Cassette.

Examine the exhaust tube (tube to the waste bottle) for kinks.

Solution

Check that the unit is plugged into a properly grounded outlet and that the power cord is firmly seated at the rear of the machine.

Tr y a nother circuit. Power unit OFFfor 10 seconds and then power ON again.

Check the condition of the line circuit breaker or fuse.

Page 35

6. Troubleshooting Cont’d.

Cycle aborted, NOT STERILE and CYCLE FAULT messages.

If kinked, straighten the tube. If the tube cannot be straightened, remove it from the push-in fitting attached to the Statim. Depress the collar on the fitting and with the other hand pull firmly on the tube. Once the tube is free of the fitting, cut the damaged section of tubing away using a sharp instrument. Be sure that you leave enough tube to reach the unit when you re-attach the tube to the exhaust fitting. If the tube is too short to remove a section, contact your SciCan dealer for a replacement (Part No. 01-100204S).

Make sure the compressor is working. To check, remove the exhaust tube from the waste bottle during the Air Drying phase of a cycle. Wear gloves to do this as the tubing, fittings, and waste bottle will be hot. Place the free end into a glass of water. If there is not a strong, steady flow of bubbles, the compressor is not functioning properly. Contact your SciCan dealer.

Record the CYCLE FAULT number. Wait a few minutes and attempt another cycle before proceeding to the next solution. If the problem persists remove the cassette. Be careful. The metal parts will be hot and the cassette will contain hot steam. Inspect the cassette to ensure that the holes in the back of the seal are perfectly aligned, and that the flexible lip of the seal is completely free. Check the exhaust tube for kinks or obstructions. If kinked, straighten the tube. If the tube cannot be straightened, remove it from the push-in fitting attached to the Statim. Depress the collar on the fitting and, with the other hand pull firmly on the tube. Once the tube is free of the fitting, cut the damaged section of tubing away using a sharp instrument. Be sure that you leave enough tube to reach the unit when you re-attach the tube to the exhaust fitting. If the tube is too short to remove a section, contact your SciCan dealer for a replacement (Part No. 01-100204S).

Check that the Statim has not inadvertently been exposed to any electrical interference. Refer to the Installation Section 3.1 Environmental Considerations, for details.

Tr y running another cycle. If the problem persists, record the cycle fault message number and contact your dealer.

Page 36

6. Troubleshooting Cont’d.

Excessive steam issuing from the front of the machine.

Message REFILL RESERVOIR, Machine will not start.

The level of the water in the reservoir is low. Refill the reservoir. Refer to the steps described in Section 3.4 Filling the Reservoir.

Message PRINTER FAULT displayed on LCD Printer is not printing.

Check for a paper jam. If the paper is jammed, follow the paper removal procedures outlined in the following section. Power unit OFF for 10 seconds and then power ON again. If the paper is still jammed, follow the disassembly procedures outlined in Section 7.5 Removing

Paper Jams.

The printer does not work. Make sure that the printer cable is connected securely

with the connector on the back of the Statim 2000 and the

Statprinter

Make sure that the printer is powered ON. Power unit OFF for 10 seconds and then power ON again.

The printer appears to work, but nothing is printed on the paper.

Ensure that the paper is loaded properly (refer to Section 7.4 Installing paper into the Statprinter). Check to see that the paper leaves the paper roll from the top of the roll. This means that the treated surface of the coated thermal paper will be in contact with the thermal print head.

Time and date are incorrect. The time and date have not been set. See Section

7.3

Setting the Time and Date

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

Yo u h a ve used water which is not steam-process distilled or is improperly distilled.

Empty the reservoir and refill with steam-process distilled water containing less than 5ppm total disolved solids (having conductivity of less than 10 µS/cm). If you have the water conductivity meter, check the quality of the water before refilling the reservoir. Refer to the steps described in Section 3.8 Shipping the Unit to empty the reservoir.

Remove and reinsert the cassette. Attempt another cycle. If the problem persists remove and check the cassette seal for misalignment or damage. Replace the seal if required. Be careful as the metal parts will be hot and the cassette will contain hot steam.

If the leak persists, turn the unit OFF, remove and unload the cassette and contact your SciCan dealer.

Page 37

7. The Optional Statprinter

7.1 The Statprinter

For the Statim 2000, the Statprinter is an easily installed stand-alone unit.

Please note that the Statprinter can only be connected to a Statim 2000 Autoclave. Connection to another device may result in damage to the Statprinter, the other device, or both. Also, the Statim 2000 should not be connected to any other printer as this will result in damage to the unit.

The optional Statprinter for the Statim 5000 is a built-in unit that can be specified when ordering your sterilizer, or can be installed later by a technician.

7.2 Installing the Statprinter

When connecting the Statprinter, or any of the cables, ensure the Statim 2000 is powered OFF. To install the printer, follow these steps:

1. Remove the

Statprinter and printer cable from the packaging.

2. Power the Statim 2000 OFF.

3. Connect one end of the printer cable to the Statim 2000 and the other to the connector on the back of the Statprinter. Tighten the screws on the cable connectors.

4. Power the Statim 2000 back ON.

5. Open the printer door by pushing the top half of the door inward.

6. Turn the printer ON. The Statim 2000 will automatically recognize the printer and will function accordingly.

7.3 Setting the Time and Date

The time and date feature is available with the optional printer only. To set the time and date, follow these steps and watch the blinking cursor on the LCD:

1. Power the Statim OFF.

2. For Statim 2000, press and hold the Unwrapped cycle button. For Statim 5000, press and hold the Wrapped cycle button.

3. While pressing the appropriate cycle button, power the Statim ON. The LCD display reads:

Figure 14

14:23 12/04/2002

HH:MM DD/MM/YY

Page 38

7. The Optional Statprinter Cont’d.

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

5. To decrease the value, press and hold the Wrapped 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 stop button.

7.4 Installing Paper into Statprinter

Use only paper approved for use with the Statprinter. The use of any other paper will damage the printer and will void the warranty. Thermal paper is available from SciCan (SciCan order no. 01-101657S).

Do not operate the printer without paper. If you run out of thermal paper, or if you do not wish to use the printer, turn it OFF.

Never pull the paper backwards through the printer. This will damage the printer mechanism.

To i n stall the paper into the printer, follow these steps:

1. Power the Statim ON.

2. Open the printer door

■

by pushing on the top half of the door.

3. Power the printer ON ■2.

4. Unroll some paper from the thermal paper roll

■

and trim the corners using the paper

cutting template included with each box.

5. Move the paper roll arm

■

into the loading position. Place the paper roll ■3on the arm so the paper strip feeds from the top of the roll and then carefully insert it into the paper feed slot ■5until it stops.

If the paper does not feed from the top, the heat sensitive side of the paper will not be in contact with the print head and the printer will not print.

6. With one hand, continue to gently feed the paper strip into the paper feed slot. With the other hand, press the paper advance button ■

until the paper feeds by itself.

Keep the paper straight when feeding it into the printer or it may jam. Do not force the paper into the slot! If the paper will not feed into the slot, pre-cut the end of the roll again and reload the paper.

Page 39

7. The Optional Statprinter Cont’d.

7. Continue to press the paper advance button ■6until

the paper feeds through the paper exit slot on the front of the printer. Then, move the paper roll ■3and arm into the operating position and close the printer door ■1. The printer is now ready to operate.

When you see a red line on one side of the paper, it is time to replace the roll.

If a paper jam occurs, and the paper cannot be removed by pressing the paper advance button

■

, do not pull the

paper backwards through the printer.

Never put a utensil or tool into the paper exit slot. For full instructions on how to remove paper jams, see Section

7.5 Removing Paper Jams.

To r eplace the paper roll ■

, follow these steps:

1. With scissors, cut the paper between the roll and the

paper feed slot ■5.

2. Remove the roll from the arm and discard the

unused portion.

3. Press the paper advance button ■

to feed the paper that remains in the printer out of the slot at the front of the printer.

4. Install the new thermal paper roll by following the instructions described in this section.

7.5 Removing Statprinter Jams

If paper jams in the printer and cannot be removed by pressing the paper advance button ■6, the printer must be disassembled. Do not pull the paper backwards through the printer and never put utensils or tools into the paper exit slot.

When paper is jammed in the printer, follow these steps to remove the jam:

1. Power the Statim OFF and unplug the unit.

2. Using scissors, cut the paper between the roll and the paper feed slot

■

3. Remove the paper roll

■

from the paper roll arm ■4and leave the arm in the

loading position.

4. Using a #1 Phillips screwdriver, remove the three screws ■

from the printer cover ■

and remove the cover.

Figure 15a

Figure 15b

■

Page 40

7. The Optional Statprinter Cont’d.

5. Note the orientation of the exposed printed wiring board ■15and the paper roll arm ■

assembled on the printer door ■1.

6. Gently lift the printed wiring board upwards and away from the printer door. Exercise care while handling the board. The printer is integral to the wiring board. Do not place strain on the connections of the ribbon cable soldered to the board. Do not remove the connector of the flexible cable from the connector header on the board. The paper drive mechanism on the underside of the wiring board is now exposed.

7. Using a pair of tweezers or fine needle-nosed pliers, carefully remove the paper from the mechanism.

When the paper is removed, reassemble the printer:

1. Carefully snap the paper roll arm

■

, in the loading position, back into the clips on the printer door ■

2. Place the printed wiring board ■

back into position on the printer door. Note the alignment of the mounting holes ■9in the wiring board and the mounting bosses ■

on the printer door. The black plastic printer body

rests between the locating ribs ■10on the inside of the printer door.

3. Ensure that the flexible cables ■

, ■14are not pinched between the printer door

and the wiring board.

4. Place the printer cover on the printer door. Ensure that the flexible cables are not pinched between the cover and the door. The power button and the paper advance button must protrude through the openings in the cover and operate freely.

5. Using a #1 Phillips screwdriver, secure the printer cover to the printer door with the three screws retained during the disassembly procedure. Do not over-tighten these screws.

6. Plug your Statim into the wall receptacle. For the Statim 2000, reconnect the printer if it was previously disconnected. Turn the power switch to the ON position.

7. Press the printer power button to the ON position. Load paper into the printer following the procedures in Installing Paper into the Statprinter.

Figure 16

■

Page 41

8. Warranty

Limited Warranty

For a period of one year, SciCan guarantees that the Statim 2000 / 5000, when manufactured by SciCan 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’s option and without charge, of any defected part(s) (except gasket and filters), provided SciCan 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 prepaid.

This warranty shall be considered to be validated, if the product is accompanied by the original purchase invoice from the authorized SciCan 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’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.

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 is excluded and disclaimed by SciCan. If you would like to learn more about SciCan products and features, visit our website at www.scican.com.

Page 42

9. Specifications

9.1 Statim 2000 – Specifications

Machine Dimensions: Length: 48.5 cm (19")

Width: 41.5 cm (16.3") Height: 15 cm (5.9")

Cassette Size (External): Length: 41 cm (16") includes handles

Width: 19.5 cm (7.67") Height: 4 cm (1.6")

Cassette Size (Internal): Length: 28 cm (11")

Width: 18 cm ( 7.1") Height: 4 cm (1.6")

Sterilization Chamber Volume: 1.8 L (61 fl. oz.) U.S. Reservoir Volume: 4.0 L (140 fl. oz.) U.S. Weight (Without water): 21 kg (46 lbs) Clearance required:

To p : 50 mm Sides: 50 mm Back: 50 mm Front: 48 cm

Maximum Steam Temperature: 138 ˚C (280 ˚F) Maximum Operating Pressure: 341 kPa abs (49.5 psia) Electrical Rating* (+ / - 10 %): 100 V, 50 / 60 Hz, 11 A

110 V, 60 Hz, 11 A 220-240 V, 50 / 60 Hz, 6 A

see serial number label for requirements specific to your unit.

Protection Class: I Protection: covered (indoor use only) Ambient Operating Temperatures and Humidity: 15 ˚C to 25 ˚C (59 ˚F to 77 ˚F)

and 25 % to 70 %

Altitude: Up to 2000 meters (6600 ft) Installation Category: 1 Statprinter Specifications:

Ty p e : T h e r m al Printer Print: 20 characters per line Print Speed: 1 line per second Paper Roll Capacity: approx. 80 sterilization cycles per roll

Page 43

9. Specifications Cont’d.

9.2 Statim 5000 – Specifications

Machine Dimensions: Length: 55 cm (22")

Width: 41 cm (16") Height: 19 cm (7.5")

Cassette Size (External): Length: 49.5 cm (19.5") includes handles

Width: 19.5 cm (7.67") Height: 8.0 cm (3.2")

Extended Cassette Size (External): Length: 56.5 cm (22.2")

Width: 19.5 cm (7.67") Height: 8.0 cm (3.2")

Cassette Size (Internal): Length: 38 cm (15")

Width: 18 cm (7.1") Height: 8.0 cm (3.2")

Extended Section (L x W x H): 11 cm (4.3") x 13 cm (5.1") x 1.6 cm (0.63") Sterilization Chamber Volume: 5.1 L (170 fl. oz.) U.S. Reservoir Volume: 4.0 L (140 fl. oz.) U.S. Weight (Without water): 33 kg (73 lbs) Clearance required:

To p : 50 mm Sides: 50 mm Back: 50 mm Front: 57 cm

Maximum Steam Temperature: 138 ˚C (280 ˚F) Maximum Operating Pressure: 341 kPa abs (49.5 psia) Electrical Rating* (+ / - 10 %): 100 V, 50 / 60 Hz, 11 A

110 V, 60 Hz, 11 A 220-240 V, 50 / 60 Hz, 6 A

see serial number label for requirements specific to your unit.

Protection Class: I Protection: covered (indoor use only) Ambient Operating Temperatures and Humidity: 15 ˚C to 25 ˚C (59 ˚F to 77 ˚F)

and 25 % to 70 %

Altitude: Up to 2000 meters (6600 ft) Installation Category: 1 Statprinter Specifications:

Ty p e : T h e r m al Printer Print: 20 characters per line Print Speed: 1 line per second Paper Roll Capacity: approx. 80 sterilization cycles per roll

SciCan Statim 2000, StatIm 5000 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual