THERMO SCIENTIFIC HERASAFE KS (01) PDF Document

To ensure the safe operation of your THERMO SCIENTIFIC HERASAFE KS, the following procedures must always be observed:

• 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 in the language of the operating and cleaning personnel 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 technical service immediately for your own safety.

Model Herasafe KS:

The safety cabinet 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. 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.

Model Herasafe KSP:

The safety cabinet 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.

Prior to the initial operation of the cabinet, the operator must perform an installation test. The test result must be documented by a test report. The cabinet must only be released for operation if it is in compliance with the operating parameters specified by the manufacturer.

After any changes to the installation conditions or after any modification to the technical system, a repeat test must be performed and the test result must be documented by a test report that shows that all operating parameters are in compliance with those specified.

The safety cabinet 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 operational safety and correct function of the THERMO SCIENTIFIC HERASAFE KS depend on the location where it is to be operated. It must be operated only at locations that meet the ambient conditions listed below.

Location requirements:

• The electrical system of the device has been 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 in which the device is installed 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 %.

Correct Location:

Choose a draft-free location where the safety cabinet does not interfere with the room traffic. Unsuitable locations are exposed to drafts from windows, doors, and ventilation systems, or are in the range of plant traffic. Preferred locations are in a draft-free section of the room and not exposed to plant traffic.

Model Herasafe KS:

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

CAUTION – Danger of tipping over! For transport, lift the device only using the designated 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!

Model Herasafe KSP:

If required, the device stand must be removed from the stand to be reinstalled onto the stand for the initial start-up after the transport.

Model Herasafe KS (Device without stand):

• Place the device without stand onto a sufficiently stable substructure so that the weight of the device frame does not rest upon the floorpan.

• Remove the protective foil from the floorpan.

Model Herasafe KS (Device with stand):

1. Slide the two crossmembers onto the retaining angles of the side members. Secure the crossmembers to the two side members using the 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.

Model Herasafe KSP:

The stand is equipped with a lifting mechanism. The four columns of the stand have threaded rods onto which the device frame can be placed and lowered.

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.

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

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

2. Lift the workplate or the workplate 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. Device without 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. Device with 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 operates on two 1.5 V alkaline cell batteries (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 system, the function of the remote control can be checked 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 the device, 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 the ratings for voltage (V) and maximum current (A) are not correct, the device must not be connected.

2. Connect the grounding plug of the device 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 that 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.

After connection, the device control runs through a start-up initialization routine and switches to OFF mode. The cabinet is now operational.

Failure messages are shown on the display as text/number combinations with the codes ER 1 to ER 6. If one of these codes appears on the display, contact Technical Service immediately.

To isolate the cause of the failure, the operating personnel can perform the following tests:

• 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.

The THERMO SCIENTIFIC HERASAFE KS has the following operating modes:

• Calibration mode (after initial start-up, version KSP)

• OFF mode: The device is at “idle”. Utilized for charging the sample chamber or for cleaning and disinfection. The front cover can be opened when the front window is completely closed. The air system blowers are off.

• Work mode: Ensures personal and material protection. The work process is run within the sample chamber. The device is in work mode when the front window has been moved into the working position and the airflow is steady.

• Standby mode: For an interruption of the work process, the front window can be lowered and the sample chamber sealed aerosol-tight. The air system output has been reduced to match the lower air requirement. The front window is closed.

• UV mode: For running the UV disinfection routine, the front window is completely lowered to protect against UV radiation. The routine cannot be run until the front window is in the “closed” position.

• 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 stops 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 can be done with any key except the audible alarm key.

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

• Stopping the downward movement: Release the ▼ key.

• Silencing the audible alarm signal: Press the audible alarm key.

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

The availability of functions in the different operating modes is as follows (x = available):

When the front window is moved out of the working position or when the pressure sensors detect a safety-relevant change of the airflow velocities, the corresponding visual and audible alarm signals are issued.

• To silence the audible alarm: Press, then release the audible alarm key.

Note: The optical alarm signals cannot be quitted. They change their status indication only if the necessary functions of the device are operational. 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. It cannot be silenced in the working position.

Changing the factory setting:

You can change the factory setting so that the audible alarm signals can be silenced (switched off) in any operating mode at any position of the front window (P7 0 = signal can be silenced, P7 1 = signal cannot be silenced).

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

• Deactivate the factory settings: Keep the potential-free contact key depressed for 5 seconds.

• To silence audible alarm signals with new setting: Press the audible alarm key.

The current time must be set at the start-up of the safety cabinet. Two display modes can be selected: CET (24:00 hours) or AM/PM (12:00 hours). The device must be in the OFF mode to set the time.

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

2. To set the time zone (CET, A, P) and the hour, press then release the ▲ or the ▼ key to scroll through values.

3. To scroll faster, keep the ▲ or the ▼ key depressed.

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

5. Set the minutes by pressing the ▲ or the ▼ key.

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

7. Store the minute value by pressing the Ctrl. key. The display shows the time.

You can call up the following data in succession by pressing and releasing the Ctrl. key for each value:

• Time (hours/minutes)

• Downflow velocity

• Operating hours after last filter replacement

• Performance Factor

Displaying the Performance Factor (PER):

The PER is a value that indicates the safety state of the cabinet. Press the Ctrl. key repeatedly until the yellow status indicator PER on the display is illuminated. The value should only be called up when the airflows have stabilized after a lead time of approx. 20 min.

To evaluate the PER:

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

• Number in the 59 to 30 range: The safety cabinet is still operationally safe. Personal and material protection is ensured. The safety system should be checked.

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

The timer function allows you to switch the safety cabinet from OFF mode to work mode at a predetermined time. The timer can only be set when the device is in OFF mode.

Setting and activating the timer:

1. Keep the timer key depressed until the ready signal sounds. The display flashes the two-digit hour display.

2. Increase or decrease the hour value using the ▲ or ▼ keys.

3. Store the hour setting by pressing the Ctrl. key. The function switches to the minute display.

4. Set the minute value using the ▲ or ▼ keys.

5. Store the minute value and activate the timer by pressing the Ctrl. key. The status indicator flashes. After a moment, the display shows the current time again. The timer is automatically activated.

Deactivating the timer:

The deferred start can be cancelled only while the device is still in the OFF mode.

• To deactivate, keep the SEt key depressed until the ready signal sounds. The safety cabinet changes to work mode. The status indicator illuminates continuously, and the display shows the current time.

Setting the UV disinfection time:

Factory setting is one hour. The time can be set between 0 and 24 hours in 30-minute increments. The unit must be in work mode (front window not closed) to set the time.

1. Keep the dIS key depressed until the ready signal sounds. The display flashes the last selected run time.

2. Set or change the time using the ▲ or ▼ key.

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

Starting the UV disinfection:

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

• Keep the dIS key depressed until the ready signal sounds. The display alternately shows “dIS” and the remaining time. The yellow status indicator dIS is illuminated.

Cancelling the UV disinfection:

While the routine is running, it can be interrupted at any time.

1. Press, then release the dIS key. The status indicator dIS goes off.

2. The display shows the current time.

If the remote control is not available, the basic functions can be controlled with the pilot switch.

• Moving the front window: The movement is controlled by depressing the pilot switch control element with the corresponding arrow symbol.

1. To raise the window, press the control element [1]. The movement stops automatically at the working position.

2. To stop the upward movement, release the control element.

3. To lower the window, keep the control element [2] depressed.

4. To stop the downward movement, release the control element.

• Silencing the audible alarm signal:

1. Move the front window to the upper and lower end positions.

2. Release the control element.

3. Press, then release the control element. The audible alarm signal remains off.

• Switching the device to OFF mode:

1. Move the front window to the upper and lower end positions.

2. Release the control element.

3. Keep the previously actuated control element depressed until the ready signal sounds.

Observance of work rules ensures a minimum of 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, the device is switched 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 an extended period, it must be completely decontaminated.

CAUTION – Decontamination measures! 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.

Note: To prevent the batteries from leaking and their contacts from oxidizing during extensive operation intermissions, remove the batteries from the remote control and store them in a dry place.

Several procedures can be applied for decontaminating the safety cabinet, depending on the potential risk and required purity.

Possible decontamination procedures:

• Wipe/spray disinfection: Standard procedure for microbiological experiments. Performed in three stages: Predisinfection, cleaning, and final disinfection.

• UV disinfection: 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 is mandatory when filters are replaced, the device is shut down, or the device is discarded.

Recommended disinfectants:

Chloride-containing disinfectants may damage some surfaces; use only disinfectants that do not contain chloride. Disinfectants with an alcohol content of more than 70% may cause embrittlement of plastic components after extended exposure. Also suited are disinfectants based on quaternary ammonium compounds.

Cleaning the exterior surfaces:

Wipe the exterior surfaces of the device clean using a solution of tepid water and commercial dishwasher solution. Then, wipe exterior surfaces dry using a soft, clean cloth.

UV lamps (replace after 1500 operating hours):

1. Remove cover from 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 cover.

Sample chamber illumination:

1. Remove the bezel retaining screws and the bezel.

2. The luminescent 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.

Replacing the front window seal:

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

2. Remove the retaining screws and the retaining strip.

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.

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

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

Recyclable materials:

HERAsafe KS

HERAsafe KSP

Airflow system HERAsafe KS

Airflow system HERAsafe KSP

Filters (Downflow and Abluft/Exhaust)

Prefilters (KSP Models)

The noise level was determined in accordance with EN ISO3744. The sound pressure level was measured at a distance of 1 m in front of the working opening. The measurement uncertainty is within a range of ± 2 dB.