THERMO SCIENTIFIC HERASAFE KSP (01) PDF Document

The following procedures must always be observed for the safe operation of your THERMO SCIENTIFIC HERASAFE KSP:

• The safety cabinet must be operated only by trained and authorized personnel.

• For any operation of this unit, the operator must prepare clear and concise written instructions based on these operating instructions, applicable safety data sheets, plant hygiene guidelines, and technical regulations, in particular:

– which decontamination measures are to be applied for the cabinet and accessories,

– which protective measures apply while specific agents are used,

– which measures are to be taken in the case of an accident.

• Repairs to the device must be carried out only by trained and authorized expert personnel.

• Keep these operating instructions close to the unit so that safety instructions and important information are always accessible.

• Should you encounter problems that are not detailed adequately in these operating instructions, please contact authorized service personnel immediately for your own safety.

The THERMO SCIENTIFIC HERASAFE KSP is a laboratory device for installation and operation in microbiological and biotechnical laboratories of safety levels 1, 2, and 3. It has been designed as a Class II microbiological safety cabinet, in accordance with EN 12469 / 2000.

The KSP model also meets the requirements from DIN 12980 / 2005-06 and can be used for the production of cytostatic agents. For cytostatic agent applications, use the lowered one-piece working plate only.

Depending on the hazard level of the agents involved, the operator must prepare in writing appropriate decontamination procedures for the device and the accessories used in the sample chamber.

Prior to initial operation, an installation test must be performed and documented. The cabinet must only be released for operation if it is in compliance with the specified operating parameters.

The THERMO SCIENTIFIC HERASAFE KSP must not be used in laboratories that do not comply with the requirements of safety levels 1, 2, and 3.

The unit must not be operated as a Class II safety cabinet if:

• no repeat test is performed after changes to the installation conditions or after modifications to the technical system,

• the alarm system of the device has issued a failure message and the cause for the failure has not been repaired.

The alarm system must not be tampered with or disabled. If alarm system components have been removed or disabled for service or repairs, the unit must only be released for operation if all alarm system components are functioning again properly.

The filters installed in the device are not capable of separating gaseous substances. Therefore, do not work with or store substances in the device:

• which in quantity or concentration are toxic,

• if a reaction with other substances may result in hazardous toxic concentrations or formation of toxic gases,

• that may form combustible or explosive mixtures in combination with air.

The safety cabinet must be operated only at locations that meet the following ambient conditions:

Location requirements:

• The electrical system is designed for an operating height of up to 2000 m above sea level.

• The mains power supply outlets should be out of normal reach to prevent accidental shut-off. Ideally, the outlets should be installed above the safety cabinet.

• The flooring of the location must be adequately strong and not flammable.

• The room must be of adequate height. For units not connected to an exhaust system, the distance between the exhaust air opening and the room ceiling must be at least 200 mm (8 in).

• The location must be equipped with an appropriate ventilation system.

• The temperature within the room must be between 15 °C and 40 °C (49 °F and 104 °F).

• The relative humidity in the vicinity of the device must not exceed 90 %.

Room Ventilation:

The room ventilation should preferably be a ventilation system that complies with the national requirements for the application. The inlet air and exhaust air openings of the room ventilation must be located so that drafts are prevented from impairing the function of the safety cabinet air system.

Choose a draft-free location where the safety cabinet does not interfere with room traffic.

• Unsuitable locations: Locations exposed to drafts from windows and doors are not suitable. Locations in the range of plant traffic or within the exhaust air range of a ventilation system are also undesirable.

• Preferred locations: Correct locations are in a draft-free section of the room and not exposed to plant traffic.

When several devices are to be installed in a line, ensure that vibrations cannot be transferred between adjacent units and that exterior surfaces of the cabinets remain accessible for cleaning and disinfection.

To prevent tilting, always transport the device using a suitable carrier, even for transport within a building. If it has a stand, separate it from the stand for transport.

CAUTION – Danger of tipping over! For transport, lift the device only using the specified lift points. Do not load the floorpan with the weight of the device frame.

CAUTION – Contusion hazard! When lifting the safety cabinet, do not put hands or fingers between the floorpan and frame.

For the KSP model, if required, the device stand must be removed from the cabinet to be reinstalled onto the stand for the initial start-up after the transport.

To assemble the stand and install the device frame:

1. Slide the two crossmembers onto the retaining angles of the sidemembers. Secure the crossmembers to the two sidemembers using the provided screws.

2. To attach the device frame to the stand, install four Allen screws loosely into the corresponding threaded holes at the underside of the device.

3. Place the safety cabinet onto the stand so that the Allen screws pass through the corresponding holes of the retaining tabs.

4. Push the device frame in the grooves of the retaining tabs all the way to the stop.

5. Tighten the four Allen screws.

The stand is equipped with a lifting mechanism to facilitate installation.

1. Unscrew the threaded rods from their hex disks by approx. 10 cm and make sure their height is identical on all four columns.

2. Place the safety cabinet onto the threaded rods. Check to see whether each guide pin is seated perfectly in its receptacle at the lower device frame.

3. Screw in each threaded rod at its column in short, even intervals all the way to the stop of the hex disk.

4. Align the working area of the safety cabinet: Place a bubble level onto the workplate and rotate the stands of the stand using a 24-mm wrench until the workplate is exactly horizontal in all directions. For the vertical alignment of the device stands, proceed from left to right and from rear to front.

The cabinet should be levelled only after it has been positioned.

1. Remove transport protection (foil) from the workplate or workplate segments.

2. Lift the workplate or segments by the wire hooks and place it/them onto the front and rear rails in the sample chamber with the wide line of holes facing forward.

3. For a device without a stand: Place a bubble level onto the workplate and align the substructure until the bubble level indicates an exactly horizontal position in all directions.

4. For a device with a stand: Place a bubble level onto the workplate and use the four levellers of the stand to effect a level state in all planes. When adjusting the device stand height, proceed from right to left and from rear to front.

The remote control uses two 1.5 V alkaline cells (AAA, Type LR 03).

Installing the batteries:

1. Open the lid of the battery housing at the bottom of the remote control by inserting a pointed instrument into the notch and prying the lid off.

2. Insert the batteries. The positive and negative poles are marked at the bottom of the battery housing.

3. Check the position of the coding switch. If the switch is not set to position 1, rotate it to that position.

4. Insert the two hinges of the lid into the joints at the battery housing and slightly press onto the lid so that the retaining clip engages.

Functional check:

After the safety cabinet has been connected to the power supply, check the function of the remote control by switching on the light within the sample chamber. Point the remote control toward the display at the sample chamber backpanel and press the light key.

WARNING – High voltage! Contact with current-carrying components may cause a lethal electric shock. Before connecting, check the plug and power supply cable for damage. Do not use damaged components.

Establishing the power supply connection:

1. Before connecting, check if the voltage of the outlet corresponds with the specifications on the nameplate. If ratings for voltage (V) and maximum current (A) are not correct, do not connect the device.

2. Connect the grounding plug to a properly grounded and fused outlet. The outlet must be fused separately using a fusible link T 16 A or a circuit breaker B 16.

3. Make sure the power cable is routed away from the counterweight and cable guide. The power cable can be secured to the device ceiling using the enclosed adhesive bases and cable ties.

4. Ensure the power supply line is not subjected to tensile or compressive force.

Installation of the power supply connection:

To protect against accidental switch-off, the outlets for the connection must be located outside the normal hand reaching range and must be accessible only to authorized personnel. Ideally, outlets should be installed above the safety cabinet.

After the start-up initialization routine is complete, the calibration routine will run:

• The display shows “CAL”.

• The routine starts automatically when the device is in work mode and runs for approximately 30 minutes. If the airflow is disturbed, the routine is cancelled and restarted automatically.

• At the end of the routine, the determined parameters for the alarm limits are saved.

NOTE: According to applicable national standards and regulations, the calibration routine is no substitute for a start-up performed by an authorized service technician.

After the routine has run, the clock should be set to the appropriate time zone.

The RS 232 interface uses a 9-pin connector with a 1:1 contact assignment.

Connection steps:

1. Turn the PC off.

2. Connect the serial interface cable to the socket at the supply interface on the front of the electrical box.

3. Connect the other end of the cable to an unassigned slot (COM 1/COM 2 etc.) on the PC.

4. Turn the PC on.

Transfer protocol configuration:

• Baud: 9600

• Data bits: 8

• Parity: none

• Stop bit: 1

• Protocol: none

• FIFO-puffer(extended modulation): enabled

Pin Occupancy:

• Pin 2: TxD

• Pin 3: RxD

• Pin 5: GND

The THERMO SCIENTIFIC HERASAFE KSP has the following operating modes:

• Calibration mode: Runs after initial start-up to determine safety system parameters.

• OFF mode: The device is at “idle”. The air system is off. This mode is used for loading, cleaning, and disinfection. The front cover can be opened when the front window is fully closed.

• Work mode: Ensures personal and material protection. This is the mode for running work processes inside the chamber. The front window is in the working position, and the airflow is steady.

• Standby mode: For interrupting the work process. The front window is lowered, and the chamber is sealed aerosol-tight. The air system operates at a reduced output.

• UV mode: For running the UV disinfection routine. The front window must be completely lowered to protect against UV radiation.

If one of the following error codes appears on the display, contact Technical Service immediately.

• Switching the device into work mode: Keep the SEt key depressed until the ready signal sounds.

• Moving the front window up: Press the ▲ key for approx. 1 second. The window will stop automatically at the working position. If starting above the working position, it stops at the maximum opening.

• Stopping the upward movement: Press, then release the ▲ key. This function can be selected with any key except the ▼ key.

• Lowering the front window: Keep the ▼ key depressed.

• Stopping the downward movement: Release the ▼ key.

• Silencing the audible alarm signal: Press the key with the bell symbol.

• Switching the device to OFF mode: Keep the SEt key depressed until the ready signal sounds.

1. Press, then release the ▲ key for approx. 1 second. The red status indicator on the display will illuminate, and the audible alarm will sound.

2. When the front window reaches the working position, the movement stops automatically. The green status indicator on the display will illuminate, and the audible alarm will turn off if the airflow is steady.

3. If the movement starts above the working position, you must first lower the window below the working position and then raise it again. To lower the front window, keep the ▼ key depressed.

4. To stop the downward movement, release the ▼ key.

When the front window is moved out of the working position or if there is a safety-relevant change in airflow, visual and audible alarms are issued.

• To silence the audible alarm, press, then release the key with the bell symbol.

NOTE: The audible alarm can only be silenced if the front window is either completely closed or has been moved to the maximum upper opening position. In the working position, the audible alarm cannot be silenced.

Changing the factory setting to silence alarms at any position:

You can change the setting to allow the audible alarm to be silenced in any operating mode at any front window position.

• Switch the device to OFF mode by keeping the SEt key depressed.

• To deactivate the factory setting (allow silencing), keep the key with the up-arrow-in-a-circle symbol depressed for 5 seconds.

• To re-establish the factory setting, repeat the same steps.

In each operating mode, the sample chamber illumination can be switched on or off.

To switch the illumination on or off, press and then release the key with the light bulb symbol.

All outlets in the sample chamber can be activated (power supply on) or deactivated (power supply off) simultaneously.

1. To activate the power supply: Press, then release the key with the plug symbol. The yellow status indicator for the internal power supply will illuminate.

2. To deactivate the power supply: Press, then release the key with the plug symbol again. The yellow status indicator will go off.

The device must be in the OFF mode to set the time. You can choose between CET (24:00 hours) and AM/PM (12:00 hours) modes.

1. Keep the Ctrl. key depressed until the two-digit hour display flashes. The minute display will show either A (AM), P (PM), or no value (CET).

2. To set the time zone (CET, A, P), press and release the ▲ or ▼ key. This is done at the same time as setting the hour.

3. To set the exact hour value, press and release the ▲ or ▼ key. To scroll faster, keep the key depressed.

4. Store the hour and time zone setting by pressing the Ctrl. key. The function will switch to the minute display (flashing).

5. Set the minutes by pressing, then releasing the ▲ or ▼ key. To scroll faster, keep the key depressed.

6. Store the minute value by pressing the Ctrl. key. The display will show the current time.

To call up values in succession, press and then release the Ctrl. key for each value.

• Displaying the downflow velocity: The value (m/s) can only be called up in work mode. Press the Ctrl. key repeatedly until the yellow LED for velocity illuminates.

• Displaying the operating hours of the HEPA filters: Press the Ctrl. key repeatedly until the yellow status indicator ‘h’ illuminates. The value indicates the total operating hours since the last filter replacement.

• Displaying the Performance Factor (PER): Press the Ctrl. key repeatedly until the yellow status indicator ‘PER’ illuminates. The PER is displayed as an integer.

Evaluating the PER value:

• 100 to 60 range: The safety cabinet is operationally safe. Personal and material protection is ensured.

• 59 to 30 range: The safety cabinet is still operationally safe, but the safety system should be checked.

• 29 to 0 range: The safety of the device may be impaired. The failure causes must only be repaired by authorized service personnel.

The timer function switches the cabinet from OFF mode to work mode at a predetermined time. It can only be set when the device is in OFF mode.

1. To set the switching time, keep the key with the clock symbol depressed until the ready signal sounds. The hour display will flash.

2. Increase or decrease the hour value by pressing, then releasing the ▲ or ▼ key.

3. To scroll through values quickly, keep the ▲ or ▼ key depressed.

4. Store the hour setting by pressing the Ctrl. key. The minute display will start flashing.

5. Set the minute value by pressing, then releasing the ▲ or ▼ key.

6. Scroll through the minute values quickly by keeping the ▲ or ▼ key depressed.

7. Store the minute value and activate the timer by pressing the Ctrl. key. The status indicator for the timer will flash, and the display will show the current time. The timer is now activated.

This setting determines the run time for the optional UV lamps or a mobile UV device. The unit must be in work mode (front window not closed) to set the time. The time can be set from 0 to 24 hours in 30-minute increments.

1. Select the function by keeping the dIS key depressed until the ready signal sounds. The display will flash the last selected run time.

2. Set or change the disinfection time by pressing, then releasing the ▲ or ▼ key.

3. Scroll through the value display in 30-minute increments by keeping the ▲ or ▼ key depressed.

4. Store the setting by pressing the Ctrl. key.

If the setting is not stored within approx. 15 seconds, the time will reset to the original value.

Starting the UV disinfection:

The UV disinfection can only be started if the front window is completely lowered (standby mode).

1. Start the routine by keeping the dIS key depressed until the ready signal sounds.

2. The display will alternately show “dIS” and the remaining disinfection time in hours and minutes. The yellow status indicator ‘dIS’ will be illuminated.

3. After the time has elapsed, the current time is displayed.

Cancelling the UV disinfection:

The routine can be interrupted at any time.

1. To cancel, press, then release the dIS key.

2. The status indicator ‘dIS’ goes off, and the display shows the current time.

If the remote control is not available, the pilot switch can be used for basic functions.

• Moving the front window: Press the up arrow to raise the window; it stops automatically at the working position. Keep the down arrow depressed to lower the window; release to stop.

• Silencing the audible alarm: Move the front window to the upper or lower end position. Release the control element. Press, then release the control element again. The audible alarm will remain off.

• Switching the device to OFF mode: Move the front window to the upper or lower end position. Release the control element. Keep the previously actuated control element depressed until the ready signal sounds.

NOTE: If the device is started with the pilot switch, the chamber illumination is switched on. If switched off with the pilot switch, the illumination is also switched off.

First, ensure the sample chamber surfaces and accessories are disinfected and cleaned according to hygiene guidelines.

Installing the accessories:

1. Lower the front window completely.

2. Open the front cover or move the front window into the maximum opening position.

3. Position the accessories in the working area of the workplate.

4. Close the front cover.

5. Move the front window to its working position and wait until the airflow has stabilized.

6. Then place samples into the chamber.

CAUTION: Personal and material protection is ensured only if the airflow system is working properly. If the alarm system issues failure messages when the front window is in the working position, stop all applications that may release harmful aerosols.

If a failure message (ER 1 to ER 6) is displayed, contact Technical Service immediately. To help isolate the cause of the failure, operating personnel may perform the following checks and measures:

• Check to see if the exhaust air opening on top of the cabinet is blocked.

• Ensure that the on-site exhaust air system is activated.

• Close doors and windows in the laboratory to prevent drafts.

• Switch off devices in the vicinity of the safety cabinet that cause air turbulence or emit excessive heat.

• Open flames in the sample chamber may impair airflow conditions.

Observing these rules ensures minimum operational safety.

Before starting an operation:

• Take off jewelry.

• Put on required personal protective gear (e.g., hand, face, or body protection).

• Clean and disinfect sample chamber surfaces at regular intervals.

During operation:

• Place samples only within the defined work area of the workplate.

• Do not place unnecessary items into the sample chamber.

• Use only disinfected and cleaned accessories for the work process.

• Do not cause air turbulence by quick hand, arm, or body movement in the sample chamber or in front of the work opening.

• Do not place accessories into the sample chamber that cause air turbulence or emit excessive heat.

• Do not block air circulation at the ventilation slots of the workplate.

After finishing an operation:

• Remove samples from the sample chamber and store them properly.

• Clean and disinfect the sample chamber surfaces, including the workplate and the floorpan. Clean and disinfect all accessories.

Interrupting an operation:

To interrupt a work process, switch the device to the OFF mode.

1. Remove all samples from the safety cabinet and store them properly.

2. Remove accessories from the sample chamber and clean and disinfect them.

3. Clean and disinfect the sample chamber surfaces, the workplate, and the floorpan.

4. Switch the device to OFF mode by keeping the ON key depressed until the indicators go off.

Shutting the unit down for an extended period:

If the unit is not to be used or stored for a long time, it must be completely decontaminated.

CAUTION: To shut the device down, the sample chamber must be disinfected completely and the plenum, including the filters, must be sterilized using formaldehyde.

1. After the device has been decontaminated, close the front window completely.

2. Disconnect the device from the power supply system.

3. To prevent batteries from leaking or oxidizing during long operation intermissions, remove them from the remote control and store them in a dry place.

The choice of procedure depends on the potential risk of the agents and the degree of purity required.

• Wipe/spray disinfection: The standard procedure for cabinets used for microbiological experiments.

• UV disinfection: Particularly suited as an intensifying additional disinfection after a wipe/spray disinfection.

• Sterilization with steam: Can be used for treating removable stainless steel components like UV lamp bezels, workplate segments, and armrests.

• Disinfection with formaldehyde: Can be performed if a sterile sample chamber is required. This procedure is mandatory when filters are replaced, when the device is shut down for an extended period, or when the device is discarded.

This procedure is performed in three stages: predisinfection, cleaning, and final disinfection.

Predisinfection:

1. Remove all samples and store them properly.

2. Remove accessories and disinfect them as recommended by their manufacturer.

3. Remove the workplate and stainless steel components for separate disinfection.

4. Spray disinfectant on all sample chamber surfaces or wipe them down.

5. Do not remove optional UV lamps from sockets; wipe them thoroughly with a damp cloth.

6. Switch the device to work mode and move the front window to the working position.

7. Allow disinfectant to react, then operate the cabinet for 15 to 20 minutes in work mode to absorb released aerosols.

Cleaning:

1. Wipe surfaces clean with a clean cloth and plenty of clear water.

2. Remove dirt residues and deposits thoroughly.

3. Remove cleaning liquid from the floorpan and wipe all surfaces dry.

Final disinfection:

1. Again, spray disinfectant on all sample chamber surfaces or wipe them clean with disinfectant.

2. Allow disinfectant to react as recommended by the manufacturer.

UV disinfection can be performed after a wipe/spray disinfection using either the optional integral UV lamps or a mobile UV device.

Using the integral UV lamps:

1. Remove the stainless steel covers from the lamp mountings in the side walls.

2. Lower the front window completely.

3. Start the UV disinfection using the remote control.

Using a mobile UV device:

1. Position the mobile UV device centered on the work area and connect it to the UV disinfection adapter.

2. Lower the front window completely.

3. Start the UV disinfection using the remote control.

Clean the floorpan using a solution of tepid water and commercial dishwasher solution.

1. Remove the working plates from the sample chamber.

2. Remove dirt residues and deposits thoroughly.

3. Wipe the floorpan clean using a clean cloth and plenty of clear water.

4. Remove the cleaning liquid from the floorpan and wipe the surfaces thoroughly clean.

5. Reinstall the working plates.

The UV lamps should be replaced after 1500 operating hours.

1. Remove the cover from the lamp housing.

2. Rotate the lamp in the socket so that the lamp contacts can be removed from the groove in the socket.

3. Insert the new lamp into the socket and rotate until the contacts engage.

4. Replace the cover.

The fluorescent tubes are installed in the front cover bezel.

1. Remove the bezel retaining screws and the bezel.

2. The tubes are retained by rotatable sockets. Rotate the tube carefully to the removal position and remove it from the socket.

3. Insert the replacement tube and rotate it to the working position.

4. Reinstall the bezel and secure it with the screws.

When the front window seal shows visible signs of wear, it must be replaced.

1. Lower the front window completely and open the front cover.

2. Remove the retaining screws and the retaining strip at the lower edge of the sample chamber opening.

3. Remove the old seal from the housing frame retaining lip.

4. Slip the groove of the new seal onto the housing frame retaining lip and push it on so that the seal fits evenly along the entire sealing surface.

5. Secure the retaining strip with the screws.

CAUTION – Contamination hazard! As the device can be used for processing infectious substances, it may be contaminated. Prior to disposal, the complete device with filters must be decontaminated by performing a formaldehyde sterilization.

Discarded cabinets or components contain reusable materials. All components, except for the HEPA filters, can be disposed of after being thoroughly cleaned and disinfected. The HEPA filters must be disposed of in accordance with applicable national and state regulations for special solid waste.

The following table lists recyclable materials:

Exterior Dimensions (mm)

Interior Dimensions (mm)

Volume, Weights, and Loads

Airflow Velocities (m/s)

Air Volume (m³/h)

Filters (Downflow and Abluft)

Prefilters