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OM0239

Page 33 of 72

April 2021

6.6.3

Assembly

a. Replace front grill (if removed).

b. Replace the work tray and carefully tighten the thumbscrews.

c. Replace perforated metal diffuser screen over the underside of the supply HEPA filter.

d. Wipe down all exposed surfaces of the work area with 70% isopropyl alcohol.

e. Prepare for aseptic operation.

¹ Available from Lab Safety Supply, Janesville, WI 53547-1368, or other laboratory, industrial, or hospital supply distributors.

²American Society of Hospital Pharmacists. 2006. ASHP Guidelines on Handling Hazardous Drugs

Am. J. Hosp. Pharm.

63:1172-1193.

7.0

General Maintenance

All maintenance actions on this equipment must be performed by a qualified

technician who is familiar with the proper maintenance procedures required

including both certification and repair.

7.1 Decontamination

No maintenance should be performed on the interior of the LabGard® ES cabinet (area behind access panels) unless the
cabinet has been microbiologically decontaminated, is known to be biologically clean, or known to be chemically inert.
Surface disinfection is performed as specified in the Cleaning Procedures section.

Hazardous Gases! Personal Protection Equipment Required.

Decontamination using hazardous gas, vapor or mist must be performed in accordance with

the specifications of NSF/ANSI 49, Annex G, EN12469, Annex J or applicable national, state, province

or local regulations

This procedure presents considerable risks and must be performed only by specially trained
and authorized service personnel in accordance with applicable national safety regulations
(e.g. Germany: TRGS 522).

The decontaminate is generated either external or internal of the sealed cabinet. The quantity of decontaminate should

follow standard or manufacturer’s recommendations based on cabinet volume. The decontaminate process should follow
standards or manufacturer’s recommendations based on the decontaminate used.

All decontaminate materials are hazardous (chemical-liquid, gas and vapor)

(Flammable

–

process) and are required to be handled properly. Follow all

product and process documentation and labelling.

CAUTION

!

CAUTION

!

CAUTION

!

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Содержание LabGard ES NU-543-300S

Страница 1: ...w Biosafety Cabinet Models NU 543 300S 400S 500S 600S Bench Console Operation and Maintenance Manual April 2021 Revision 10 Series 1 Manufactured By NuAire Inc 2100 Fernbrook Lane Plymouth MN 55447 Toll Free 1 800 328 3352 In Minnesota 763 553 1270 Fax 763 553 0459 ...

Страница 2: ...particulate contaminants as prescribed in EN 12469 and NSF ANSI 49 Please read this manual carefully to familiarize yourself with proper installation maintenance and operation of the cabinet Other reference and guideline materials are available through the following web sites www hc sc gc ca www cdc gov od ohs www absa org www cabs acsb ca www ebsaweb eu www inspection gc ca www who int www biosaf...

Страница 3: ...ngs are appended in the back flap of this manual along with any modifications and or additions to procedures as outlined in this manual A copy of the original factory test report is also appended to this manual In case this manual and or test report is lost or misplaced NuAire retains a copy in our files A replacement copy can be obtained by calling or writing NuAire Inc stating the model number a...

Страница 4: ...essments 7 9 Cleanliness Classification Test for Pharmacy Application 7 10 Main Control Board Description and Replacement 7 11 Digital Airflow Sensor Description and Replacement Section No 8 Error Messages Troubleshooting and Option Diagnostics Section No 9 Remote Contacts Section No 10 Optional Equipment 10 1 Ultraviolet Light Section No 11 Electrical Environmental Requirements Section No 12 Disp...

Страница 5: ...flow Schematic and the application of environmental controls as required in the field of biological research or chemical containment The LFBSC when used with proper technique is an effective primary engineering control in obtaining the optimum product quality while reducing the potential for exposure of both product and personnel to airborne biological or particulate chemical agents in low to mode...

Страница 6: ...hile specific agents are used o 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 cabinet so that safety instructions and important information are always accessible Should you encounter problems that are not detailed adequately in the operating instructi...

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Страница 8: ...OM0239 Page 8 of 72 April 2021 2 0 Models and Features The model NU 543S LabGard ES Class II Laminar Flow Biosafety Cabinet is manufactured in four sizes 3 ft 9m 4 ft 1 2m 5 ft 1 5m and 6 ft 1 8m ...

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Страница 13: ...hipments 4 1 1 Terms are factory unless stated otherwise Therefore it is important to check each shipment before acceptance 4 1 2 If there is visible damage the material can be accepted after the driver makes a notation on the consignee s copy of the freight bill Then an inspection must be made to verify the claim against the carrier This inspection is the basis of your filing the claim against th...

Страница 14: ...on panel should be used A MINIMUM CLEARANCE OF 6 152MM IS REQUIRED FROM THE TOP OF THE CABINET TO THE CEILING FOR PROPER VENTILATION OF THE EXHAUST EFFLUX If this cabinet is used in a pharmacy application it is strongly recommended Per OSHA NIOSH and ASHP that the cabinet be exhausted to the outside In addition if this cabinet is used in microbiological application with minute quantities of volati...

Страница 15: ...de a 2 51mm overhang and seal the interface of the bench and cabinet using RTV caulk as above 5 2 4 Gas Service NuAire doesn t recommend the use of natural gas within the LFBSC but if gas service is determined to be necessary for the application appropriate safety measures must take place All NuAire LFBSC s have precautionary warning labels that say the following Use of explosive or flammable subs...

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Страница 17: ...s Biosafety Cabinets may be hardwired optional or plugged into an outlet with protective earthing connection with the standard power cord The cabinet requires 230 VAC 50 60 Hz single phase current rating varies per cabinet size reference Electrical Environmental Requirements It is recommended that power to the cabinet whether hardwired or plug connected be on its own branch circuit protected with ...

Страница 18: ... test Inflow velocity test Airflow smoke patterns Site installation assessment tests The testing methods and equipment required are specified on the factory inspection report included with this manual see insert in back cover NOTE IT IS RECOMMENDED THAT THESE TESTS BE PERFORMED BY A QUALIFIED TECHNICIAN WHO IS FAMILIAR WITH THE METHODS AND PROCEDURES FOR TESTING BIOSAFETY CABINETS SEE INSERT NOTE ...

Страница 19: ...ea Sidewall One Backwall Left or Right Work Surface Cabinet Size Inches mm Height Fully Assembled Height Minimum for Transport Width Depth with Armrest Removed 60 7 8 1546 59 1499 41 5 8 1057 31 7 16 799 60 7 8 1546 59 1499 53 5 8 1362 31 7 16 799 60 7 8 1546 59 1499 65 5 8 1669 31 7 16 799 60 7 8 1546 59 1499 77 5 8 1972 31 7 16 799 Work Access Opening Inches mm Standard Opening Height Optional S...

Страница 20: ...Motor Controller that provides automatic compensation constant volume control for both filter loading and line voltage variances Monitor and display airflow velocity performance via Intelliflow Monitor Display time of day and temperature The LabGard ES NU 543S offers the latest digital microprocessor design technology for improved cabinet performance and safety The FlowGard control system integrat...

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Страница 22: ...to the outlets LED above indicates full blue for outlets on blinking blue during auto timer duration 6 1 2 6 Red Alarm LED The red alarm LED will indicate any alarm condition and remain indicating until the alarm condition is cleared A blinking red alarm LED indicates a power interruption has occurred 6 1 2 7 Audible Alarm Silence Key The audible alarm silence key allows user interaction to silenc...

Страница 23: ... of power Just as the initial power up the red alarm LED will blink to indicate power up status along with the display message of power on reset 6 1 4 Standby Mode When the BSC is not in use the display will indicate the NuAire logo with the current time provided in the upper right corner Any of the function keys except the blower that initiates run mode may be turned on and off in standby mode Th...

Страница 24: ...e and be displayed The top line will show the items being displayed along with the time of day The center of the display will show the values of the items the unit of measure and the temperature The bottom of the display or message area will show active alarms and other status information The right hand side of the display will show a gauge depicting the velocity limits and setpoint with an arrow ...

Страница 25: ...arm description Audible alarms will produce an alarm tone for 30 seconds then ring back for 2 seconds of every 5 seconds Pressing the alarm silence key will silence the audible alarm for 15 minutes initially then will start the ring back function again The bottom of the display or message area will indicate alarms errors or other notable conditions Since the message area is limited to one line of ...

Страница 26: ...ange Press key to back up one level or repeated times to return to normal run or standby mode 6 1 8 2 Time Menu The time menu contains both time of day and auto timer duration Upon selecting the time menu from the main menu the display will indicate the following Time of Day o Press ENT key to select time of day The display will indicate the following o Press ENT key to advance through the followi...

Страница 27: ...d is provided by the airflow sensor in the cabinet s exhaust airstream The temperature displayed may indicate a slightly higher value than the laboratory room temperature due to some heat generation of the cabinet itself However the temperature may be adjusted by an offset or deviation from the indicated temperature plus or minus in tenths of a degree calibration procedure by the following Press o...

Страница 28: ... should be evaluated by appropriate safety personnel 6 2 2 Minimize Penetration of Air Curtain The minimum number of items necessary should be placed into the cabinet to prevent overloading but the work should also be planned to minimize the number of times an operator s hands and arms must enter and leave the air curtain at the open face The ideal situation is to have everything needed for the co...

Страница 29: ...ecaution is merely an extension of good aseptic technique as practiced on open bench tops The standard laboratory practices designed to minimize creation and or release of aerosols to the environment should not be discontinued Items of equipment in direct contact with the etiologic agent must remain in the cabinet until enclosed or until surface decontaminated Trays of discard pipettes must be cov...

Страница 30: ...s Materials should be arranged so that clean dirty used and virus materials are well separated Passage of contaminated materials over uninoculated cultures or clean glassware should be avoided and transfer of viable materials should be performed as deeply into the cabinet away from open face as possible 6 3 4 Air Purge Additional purging of the workspace without user activity should be allowed for...

Страница 31: ...e feet are resting on the floor chair foot support or foot rest Also be sure back is fully supported with proper chair adjustments Forearm elbow support The cabinet is provided with a non metallic forearm support on the work access opening Periodic mini breaks during work practice should be taken resting forearm to avoid stress and fatigue Elbow rests that can provide support for particular work p...

Страница 32: ... the full open position With the view screen in the full open position personnel protection is compromised and a full faced HEPA filtered respirator must be worn c Clean all readily accessible surfaces of the cabinet NOTE NuAire does not offer any product warranty with respect to cleaning material compatibility USE AT YOUR OWN RISK The information provided above is from raw material suppliers and ...

Страница 33: ...ogically decontaminated is known to be biologically clean or known to be chemically inert Surface disinfection is performed as specified in the Cleaning Procedures section Hazardous Gases Personal Protection Equipment Required Decontamination using hazardous gas vapor or mist must be performed in accordance with the specifications of NSF ANSI 49 Annex G EN12469 Annex J or applicable national state...

Страница 34: ...ontrol center Reconnect power to the cabinet The outlets and blower can then be activated 9 Seal front and top openings using plastic and tape BE SURE CABINET IS TOTALLY SEALED TO PREVENT ANY LABORATORY EXPOSURE TO DECONTAMINATION GAS VAPOR OR MIST 10 Perform decontamination procedure 7 1 2 Auto Decon The Auto Decon process is intended to be used with any automated cabinet decontamination process ...

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Страница 36: ...ges of the front window sealed with a low residue tape 6 Tubing connected to the inlet and outlet of X10 7 Insertion of Hydrogen Peroxide H2O2 sterilant cup and desiccant cartridge to X10 8 Current BSC process selected Decontamination Process 9 The X10 will perform one 1 Preheat Dehumidification Decontamination and Aeration after start of the program 10 Preheat The cabinet is heated to 31 C 11 Deh...

Страница 37: ...amination system and cabinet Total duration is the total automated decontamination cycle time so both the cabinet Auto Decontamination time duration and the automated decontamination system cycle time are sequenced and run together Blower run time is the length of time the blower will run during and of the 4 possible blower start times Blower start schedule is the start time of 4 possible blower s...

Страница 38: ...sary to remove the lamp assembly 1 Switch cabinet light switch off 2 Remove the screws at each upper side of the control center and allow the control center to rotate down resting on the safety straps 3 The lamp is now directly exposed for replacement 4 The lamp is removed by displacing the bulb to one side against the compressible bulb holder and lifting out the lamp 5 Reverse the procedure to re...

Страница 39: ...lock washers The screws have O rings and should be replaced if damaged or badly deformed The interior of the cabinet is now fully exposed for replacement of the filters and motor blower The lowest window position will require the armrest to be removed Step 3 Filter Removal It is not always necessary to replace both the supply and exhaust filters at the same time If during the course of certificati...

Страница 40: ...6mm 20 508mm x 14 366mm x 11 1 2 292mm Filter Manufacturer Camfil Farr Camfil Farr NU 543 400S NuAire Part Number A 980962 02 A 980962 13 Filter Size 21 533mm x 44 1118mm x 3 76mm 20 508mm x 22 559mm x 11 1 2 292mm Filter Manufacturer Camfil Farr Camfil Farr NU 543 500S NuAire Part Number A 980962 03 A 980962 14 Filter Size 21 533mm x 56 1422mm x 3 76mm 20 508mm x 30 762mm x 11 1 2 292mm Filter Ma...

Страница 41: ...op of the hood Tighten the spring loaded bolts 4 places depressing the gasket material by 1 8 inch 3mm Step 5 Motor Blower Assembly Removal a It is recommended that the motor blower to be removed as a single unit To remove disconnect electrical connections to the motor remove the HEPEX pressure plenum and unbolt the motor blower assembly from the roof of the cabinet 4 places Always inspect the rub...

Страница 42: ...enu perform the following Press and hold key then press ENT and keys sequentially releasing the key after the 3 key sequence The following service parameter display should appear Navigation through the service parameter menu is the same as the operator menu Press on keys to select a menu item which will be highlighted inversely Menu selection moved in a round robin pattern Press ENT key on a selec...

Страница 43: ...ith clean filters The maximum rpm is a known fixed value based on the DC ECM motor used The difference between the maximum and current rpm determines the filter life percentage The filter life percentage starts at 100 and as the current rpm increases due to filter loading the filter life decreases Inflow Velocity Default values Low Limit 46fpm Setpoint 53fpm High Limit 61fpm Filter Life Filter Lif...

Страница 44: ...adjusts or balances the exhaust airflow as well as makes up for filter resistance tolerances Since it has been NuAire s experience that the filters may not load evenly choke adjustments may be necessary for proper cabinet airflow balance and performance DC ECM motor PWM signal DC voltage should also be monitored and recorded upon final calibration The DC voltage may be measured using a digital vol...

Страница 45: ...se blower speed Greater than 110LFPM 56 m s First decrease blower speed to achieve the exhaust excess then close the choke plate to achieve the balance In this fashion the downflow should remain nearly constant i e what the reduced speed took away the choke plate restores Note The choke plate adjustment requires a standard blade screwdriver To adjust loosen the liquid tight fitting around the chok...

Страница 46: ...08 53mls Offset value may be positive or negative as needed Once desired offset value is achieved press ENT key to accept Press to exit 7 5 4 4 Alarm Verification If desired the alarm setpoint can be verified by entering into the alarm verification menu The airflow alarm is always active in this menu so if the blower is turned on in this menu an airflow alarm will be active until the airflow is ab...

Страница 47: ...T key to accept Nite Care blower speed calibration Recommended Measurement Methods for Cabinet Downflow and Inflow Downflow Measurement A Instruments TSI 8355 Thermo anemometer B Procedure Supply filter efflux is measured on a grid in a horizontal plane 4 inches 102mm above the bottom edge of the window Measurements should be taken over a period of at least 1 minute for each position C Primary Tes...

Страница 48: ... Average downflow velocity 60 LFPM 5 LFPM 30 m s 025 m s 2 Individual readings must be within 20 of the average downflow velocity_____ to _____ fpm _____ to _____ m s B Inflow Measurement a Recommended Instrument Shortridge Flowhood ADM 870 or TSI 8355 Thermo anemometer b Primary Procedure The primary procedure to determine inflow velocity uses a Direct Inflow Measurement DIM Instrument i e Shortr...

Страница 49: ...92 528 24 990 635 29 188 741 33 386 848 37 584 955 41 782 1061 45 980 1168 50 178 1274 54 375 1381 600S 4 102 8 158 207 12 316 313 16 474 481 20 632 524 24 790 630 28 948 735 33 106 841 37 264 946 41 422 1052 45 580 1158 49 738 1263 53 896 1369 58 054 1475 62 212 1580 66 375 1686 Number of Readings Average Velocity of Constricted Area ft min ms 1 Average Velocity of Constricted Area fpm m s 2 X Co...

Страница 50: ...nd should be removed If an air gap exhaust transition is provided the air gap must be sealed with duct tape or other suitable means to prevent contaminated air from migrating into the exhaust efflux All exhaust blowers fans should be turned off during the check The exhaust sensor shroud can also be removed for the exhaust filter integrity check Replace the exhaust sensor shroud immediately after t...

Страница 51: ...ape from inside the cabinet 3 No smoke refluxes out of the cabinet once drawn in nor does smoke billow over the worksurface or penetrate onto it 4 No smoke shall escape from the cabinet 7 8 Site Installation Assessment Tests These tests are performed to verify the sash position airflow or pressure setpoint where an audible and or visual alarm will activate to signify unfavorable operating conditio...

Страница 52: ...erformance Canopy Exhaust Transitions Step 1 Introduce a visible medium source into the canopy air intake s while slowly reducing the exhaust volume until there is a loss of capture of the visible medium into the canopy air intake s The audible and visual canopy alarms shall respond within 15 seconds and the cabinet fan s will continue to operate Step 2 Return exhaust volume to original value NOTE...

Страница 53: ...est using non hazardous materials A minimum of three 3 1 minute particle counts shall be sampled and recorded while the user simulates aseptic compounding manipulations At Rest Particle Count Test Take 5 test points in 1 minute intervals on a grid in a horizontal plane as measured approximately 6 inches 152mm above the worksurface The grid location is designed as the workzone center point and each...

Страница 54: ... 2 AMPS 1 AMP 2 NU 543 400S 8 AMPS 3 AMPS 2 2 AMPS 1 AMP 2 NU 543 500S 10 AMPS 3 AMPS 2 2 AMPS 1 AMP 2 NU 543 600S 10 AMPS 3 AMPS 2 2 AMPS 1 AMP 2 7 10 3 Main Control Board Replacement Note All setup and calibration data will be lost the memory reinitialized to the default values and all control functions reset to an initial cabinet power condition If possible before the main control board replace...

Страница 55: ...he airflow sensor function utilizes two thermistors that provide a constant current source One thermistor is a reference that uses a very low current source The other thermistor is the airflow measurer that uses a very high current source As airflow passes over the thermistors the airflow removes heat from the thermistor measuring airflow The loss of heat from the thermistor causes the voltage fro...

Страница 56: ...ps Check voltage coming out of main control board to light ballasts Cabinet blower won t turn on Green LED above blower key indicates the blower should be on Airflow Alarm Check blower fuse on main control board Check AC voltage coming out of main control board Check wiring to blower Check blower motor Check DC motor PWM signal on main control board Power on reset Indicates a power interruption ha...

Страница 57: ... Menu selection moved in a round robin pattern Press ENT key on a selected menu item will either 5 Drill further down the menu tree 6 Allow editing of the item value which will now be highlighted o Press or key to change the selected value o Press ENT key to accept the change o Press key to cancel the change Press key to back up one level or repeated times to return to normal run or standby mode T...

Страница 58: ... via the outlet key If the outlet power sync is active the blower must be actively running for the outlet power to turn on 8 2 2 Function Options Disable Intelliflow If this function is active All airflow display and alarm functions are turned off Allow UV light anytime Normally the UV light is interlocked with the window being in the closed position For service purposes only if this function is a...

Страница 59: ...the blower is actively running and a power interruption occurs The blower will automatically come back on when power is restored If this function is turned off the blower will not automatically come back after a power interruption but would require the user to press the blower key to restart the blower Require Password Normally it is required to use a password i e 3 key press sequence of the blowe...

Страница 60: ...n time is the length of time the blower will run during and of the 4 possible blower start times Blower start schedule is the start time of 4 possible blower start times during the decon cycle Initiate decon cycle provides a short safety check list the must be answered yes before the decon cycle can be initiated Once the Auto Decon cycle is initiated the following display indicates cycle progress ...

Страница 61: ...ted whenever the blower key is pressed and the blower key LED indicator is on or blinking Contact ratings are 250 VAC maximum at 2 Amps 9 2 Alarm Relay The alarm relay contacts are normally open and closed contact closure outputs which are activated whenever an airflow alarm condition occurs Contact ratings are 250 VAC maximum at 2 Amps 9 3 15VDC Output The 15VDC 100mA output is active when power ...

Страница 62: ...une 1976 Since ultraviolet rays will not penetrate ordinary glass it is recommended that the sliding window be closed while the ultraviolet light is on within the cabinet or that personnel leave the cabinet face area 10 1 2 Operation The operation of the ultraviolet light is accomplished by closing the sliding window and pressing the UV switch located on the front panel The sliding window is inter...

Страница 63: ...tem monitors UV light usage hour and when the 5000 hour point is reached The UV light LED indicator will blink fast along with the display message Replace UV light To view hours or reset timer perform the following Press and hold ENT key for 3 seconds until the menu appears Press or keys to select UV lamp hours Press ENT key to highlight hours Press or key simultaneous until hours zero Press ENT k...

Страница 64: ...p hermolyticus alpha type 5 500 Staphylococcus aureus 6 600 Staphylococcus albus 5 720 Micrococcus sphaeroides 15 400 Sarcina lutea 26 400 Pseudomonas fluorescens 7 040 Escherichia coli 7 040 Proteus vulgaris 7 480 Serratia marcescens 6 160 Bacillus subtilis 11 000 Bacillus subtilis spores 22 000 Spirillum rubrum 6 160 References a Luckiesh Matthew 1946 Application of Germicidal Ethyemal and Infra...

Страница 65: ... comparable to public mains such as hospital and research laboratories and most industrial laboratories the expected transient overvoltage is 2500 V for a 230 V supply and 1500 V for a 120 V supply 11 5 Pollution Degree 2 0 Pollution degree describes the amount of conductive pollution present in the operating environment Pollution degree 2 assumes that normally only non conductive pollution such a...

Страница 66: ... Grill Stainless Steel Worksurface Stainless Steel Window Faring Stainless Steel Window Glides HDPE Window Safety Glass Window Frame Stainless Steel Front Service Panel Painted Steel Front Decorative Panel Painted Steel Control Center Painted Steel Supply Diffuser Aluminum Exhaust Filter Aluminum HEPA Filter Frames Painted Steel Hepex Bag PVC Blower Wheel and Housing Steel Motor Various Steel Prin...

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