36E77619R0017-037.pdf

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AIREGARD™ ES Energy Saver Vertical Laminar Flow Clean Workstation

Model NU-140 Bench Top Model

Operation and Maintenance Manual

October, 2018 Revision 1

Series 1

(115VAC ONLY)

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

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Model NU-140 Bench Top Model

Operation and Maintenance Manual

Table of Contents

Section No. 1 .............................................................................. General Description Section No. 2 .............................................................................. Models & Features Section No. 3 .............................................................................. Shipments Section No. 4 .............................................................................. Installation Instructions

4.1 ...................................................................................... Location

4.2 ...................................................................................... Set-up Instructions

4.3 ...................................................................................... Certification Testing Methods and Equipment

Section No. 5 .............................................................................. Operating the Laminar Flow Clean Workstation

5.1 ...................................................................................... Operator Controls & Indicators

5.2 ...................................................................................... Operating Guidelines

5.3 ...................................................................................... Ergonomics

5.4 ...................................................................................... Cleaning Procedures

Section No. 6 .............................................................................. General Maintenance

6.1 ...................................................................................... Fluorescent Lamp Bulb Replacement

6.2 ...................................................................................... HEPA Filter Replacement

6.3 ...................................................................................... Prefilter Replacement

Section No. 7 .............................................................................. Error Indicators and Troubleshooting Section No. 8 .............................................................................. Polycarbonate Material Compatibility Section No. 9 .............................................................................. Remote Contacts Section No. 10 ............................................................................ Optional Equipment

10.1 .................................................................................... Ultraviolet Lamp

10.2 .................................................................................... Electrical/Environmental Requirements

Section No. 11 ............................................................................ Electrical/Environmental Requirements Section No. 12 ............................................................................ Disposal and Recycle Insert .......................................................................................... Replacement Parts List, Warranty

Manual Drawings

BCD-19868..........................................................Specification Drawing NU-140-330

BCD-19847..........................................................Specification Drawing NU-140-430 BCD-19869..........................................................Specification Drawing NU-140-530 BCD-19665..........................................................Specification Drawing NU-140-630

Assembly Drawings

ACD-06899..........................................................Blower Brace Removal BCD-19015..........................................................Base Stand Telescoping with Leg Levelers BCD-19016..........................................................Base Stand Telescoping with Caster BCD-19017..........................................................Hydraulic Base Stand with Castors BCD-19018..........................................................Hydraulic Base Stand with Leg Levelers BCD-16521..........................................................AEROMAX™ Front Panel

BCD-19998..........................................................HEPA Filter Replacement BCD-20293..........................................................Outlet Option Installation

Electrical Schematics

BCD-19772..........................................................Electrical Schematic 115V

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Model NU-140 Manufactured By:

NuAire, Inc., Plymouth, Minnesota

1.0 General Description

NuAire AIREGARD™ Vertical Laminar Flow Clean Workstations utilize the newest technologies in laminar airflow design, materials and manufacturing processes. The clean workstation can be used where clean airflow per ISO 14644-1 is required for the preparation of injectable drugs, IV solutions, tissue culture, optics, microelectronics, etc. The clean bench should not be used for any work that involves biological agents assigned a level of Risk 1 through 4 as classified by the Centers for Disease Control (CDC), Atlanta, Georgia, since the Vertical flow offers no personnel protection against these agents. The clean bench should only be used to protect the product from contamination. The clean bench is optionally available with a base stand, placing the work surface at 30” (762mm) or 36” (914mm). A significant number of design innovations give the NuAire Laminar flow equipment superior performance qualities in airflow, lighting, noise levels and vibration.

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1.1 Safety Instructions

These safety instructions describe the safety features of the AIREGARD™ Vertical Laminar Flow Clean Workstation model NU-140. The workstation has been manufactured using the latest technological developments and has been thoroughly tested before delivery. It may, however, present potential hazards if it is not used according to the intended purpose or outside of operating parameters. Therefore, the following procedures must always be observed:

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

• For any operation of this unit, the operator must prepare clear and concise written instructions for operating and cleaning, utilizing applicable safety data sheets, plant hygiene guidelines, and technical regulations, in particular.

o which decontamination measures are to be applied for the workstation and accessories, 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 unit so that safety instructions and important information are always accessible.

• Should you encounter problems that are not detailed adequately in the operating instructions, please contact your

NuAire Representative of NuAire technical Services.

1.2 Explanation of Symbols

NOTE:

CAUTION used without the safety alert symbol indicates a potentially hazardous situation which, if not avoided, may result in property damage.

Potential electrical hazard, only qualified person to access.

Used for important information.

Biohazard

Ground, Earth

CAUTION:

Lead Free

Chemical Hazard

Flammable Hazard

Hazardous Gases! Personal Protection Equipment Required.

Safety alert symbol indicates a potentially hazardous situation which, if not avoided, could result in death of serious injury.

Safety alert symbol indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury.

WARNING !

CAUTION !

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2.0 Models and Features

NuAire's Model Number NU-140 designates the basic design series of AIREGARD™ Vertical Laminar Flow Clean Workstation with the blower/motor located above the work surface (i.e. bench series). Model numbers are shown below.

Model Number

NU-140-330

NU-140-430

NU-140-530

NU-140-630

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3.0 Shipments

NuAire takes every reasonable precaution to insure that your AIREGARD™ Clean Workstation arrives without damage.

Motor carriers are carefully selected and shipping cartons have been specially designed to insure your purchase. However, damage can occur in any shipment and the following outlines the steps you should take on receipt of a NuAire AIREGARD™ Clean Workstation to be sure that if damage has occurred, the proper claims and actions are taken immediately.

3.1 Damaged Shipments

3.1.1 Terms are factory, unless stated otherwise. Therefore, it is important to check each shipment before acceptance.

3.1.2 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 the carrier.

3.1.3 If concealed damage is found, it is absolutely necessary to NOTIFY THE FREIGHT AGENT AT ONCE and request an inspection. Without this inspection, the transportation company may not accept a claim for loss or damage. If the carrier will not perform the inspection, an affidavit must be prepared stating that he was contacted on a certain date and that he failed to comply with the request. This, along with other papers in the customer's possession will support the claim.

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4.0 Installation Instructions

4.1 Location

Within the laboratory, pharmacy, production area, etc., the ideal location for the clean workstation is away from personnel traffic lanes, air vents (in or out), doors and/or other source of disruptive air currents. If drafts or other disruptive air currents exceed the face velocity of the HEPA filter, the potential exists for contaminated air to enter the work area of the workstation. Please note, however, that the work area has been constructed to minimize the effect of air currents by providing sidewalls that are an extension of the HEPA filter flow area.

Where space permits, a clean six (6) inch (152mm) area should be permitted on each side of the workstation for maintenance purposes. The electrical outlet into which the workstation is connected should be readily accessible.

The workstation shall be positioned as not to obstruct the power supply outlet or the circuit breaker distribution panel.

4.2 Set-Up Instructions

Remove outer shipping protection (carton or crating). If the workstation is fastened to a base skid, it is usually the best procedure to leave the skid in place until the workstation is located in its approximate position to facilitate ease in handling.

It can then be removed from the skid by removing the four bolts holding the workstation to the skid.

4.2.1 Motor Shipping Bracket

The motor is securely fastened to the workstation during shipment to prevent damage to the blower housing mounting brackets. The procedure for removing the motor shipping bracket is shown in Drawing ACD-06899.

4.2.2 Base Stand Assembly

The base stand is shipped K.D. in a separate carton and is assembled per the Drawing accompanied with the unit.

With a forklift or other suitable lifting device, lift the NU-140 between the top of the skid and the bottom of the workstation, slightly off of the floor and remove the four bolts holding the skid to the workstation (one in each corner). Now lift the workstation on top of the base and bolt the base stand to the workstation using four 4/20 x ¾” (18mm) bolts and washers provided. Place the workstation in its desired location.

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4.2.3 Gas Service

NuAire doesn't recommend the use of natural gas within the clean bench, but if gas service is determined to be necessary for the application by the appropriate safety personnel, appropriate safety measures must take place.

Once the determination has been made by the appropriate safety personnel, the application of natural gas must be performed in accordance to national, state and local codes.

IT IS ALSO STRONGLY RECOMMENDED THAT AN

EMERGENCY GAS SHUTOFF VALVE BE PLACED JUST

OUTSIDE THE CLEAN BENCH ON THE GAS SUPPLY LINE.

All NuAire clean benches meet the safety requirements of UL and CSA for Laboratory Equipment. To comply with these safety requirements, NuAire uses only certified gas valves. In addition, if external piping is required, only black pipe is used for this application.

As previously stated NuAire doesn't recommend the use of natural gas within the clean bench and ASSUMES NO RESPONSIBILITY FOR ITS USE. USE AT YOUR OWN RISK. The Bunsen burner flame within the clean bench disrupts the laminar air stream, which must be maintained for maximum efficiency.

IF THE PROCEDURE DEMANDS USE OF A FLAME, A BUNSEN BURNER

WITH ON DEMAND IGNITION IS STRONGLY RECOMMENDED.

DO NOT USE CONSTANT FLAME GAS BURNERS.

During use, the Bunsen burner should be placed to the rear of the workspace where resulting air turbulence will have a minimal effect.

4.2.4 Plumbing Services

Ground key cocks with the type of service specified by the snap-in button on the handle, are located in the work zone. The ground key cocks are not recommended for pressures over 30 p.s.i. Reducing valves should be installed external to the workstation if necessary. Ground key cocks should never be used for oxygen service. A special needle valve for oxygen service is required and available upon request.

External connection is to 3/8 inch (10mm) FPT coupling through the sidewalls. Connection to plant utilities should be made with proper materials for the individual service and according to national and/or local codes. Observe all labels pertaining to the type of service and operating pressure.

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4.2.5 Electrical Services

The Vertical Laminar Flow Clean Workstation may be "hardwired" (optional) or connected via an electrical power cord, which is standard. The unit requires 115 VAC, 60 Hz, single phase. (Current rating varies per workstation size, reference Electrical/Environmental Requirements).

It is recommended that power to each work station (power is defined by each work station’s power cord), whether individual or joined work stations, be on its own branch circuit, protected with a circuit breaker at the distribution panel.

THIS UNIT CONTAINS ELECTRONIC BALLASTS FOR THE FLUORESCENT LIGHTING. ELECTRONIC BALLASTS

OPERATE WITH HIGH INRUSH CURRENT. IT IS NOT RECOMMENDED TO USE THIS PRODUCT WITH

GROUND FAULT CIRCUIT INTERRUPTERS (GFCI'S) BECAUSE THE BALLASTS MAY CAUSE THE GFCI TO TRIP.

If a "hardwired" (conduit) connection is desired, an electrical junction box is provided on the top of the workstation with a removable cover. All wiring connections to the junction box should be done according to the National Electrical Code and/or local codes by a qualified electrician.

4.2.6 Final Assembly

The exterior surfaces and viewing glass are easily cleaned with any mild household detergent cleaner using a soft cloth. Harsh chemicals, solvent-type cleaners and abrasive cleaners should not be used. See section 5.4 for cleaning procedures. Turn the workstation on and let it operate for 5 minutes before using it as a clean bench.

4.3 Certification Testing Methods and Equipment

After installation and prior to use, NuAire recommends that the workstation be recertified to factory standards.

At a minimum, the following tests should be performed.

1. HEPA filter media

2. Filter frame leak test

3. Airflow velocities

The testing methods and equipment required are specified on the factory inspection report included with this manual.

IT IS RECOMMENDED THAT THESE TESTS BE PERFORMED BY A QUALIFIED TECHNICIAN WHO IS FAMILIAR WITH

THE METHODS AND PROCEDURES FOR CERTIFYING CLEAN BENCHES.

AFTER THE INITIAL CERTIFICATION, NUAIRE RECOMMENDS THAT THE WORKSTATION BE RECERTIFIED AT A MINIMUM ON AN ANNUAL BASIS AND AFTER EVERY FILTER CHANGE OR MAINTENANCE ACTION OR ANY TIME

THE OPERATOR FEELS IT IS NECESSARY.

Note that the NuAire Clean Workstations, filters and seals provide premium performance; Quality control in both design and manufacturing insure superior reliability. However, protection to the product is so important, that certification to the performance requirements should be accomplished as stated to insure conformance to factory standards.

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AIREGARD™ ES Energy Saver Vertical Laminar Flow Work station

Models NU-140-330/430/530/630

Catalog Number Catalog Number NU-140-330

Nominal 3 foot (0.9m)

NU-140-430

Nominal 4 foot (1.2m)

NU-140-530

Nominal 5 foot (1.5m)

NU-140-630

Nominal 6 foot (1.8m) Performance Specifications

1. Product Protection

IEST-RP-CC002.4

ISO 14644-1

ISO 14644-1 ISO 5 ISO 5 ISO 5 ISO 5

Style of Work station Bench top/console w/base stand/storage Work station

Bench top/console w/base stand/storage Work station

Bench top/console w/base stand/storage Work station

Bench top/console w/base stand/storage Work station

Work station Construction

16/18 GA, powder coated steel exterior;

16/18 GA type 304 SST work zone

16/18 GA, powder coated steel exterior;

16/18 GA type 304 SST work zone

16/18 GA, powder coated steel exterior;

16/18 GA type 304 SST work zone

16/18 GA, powder coated steel exterior;

16/18 GA type 304 SST work zone

Diffuser for Air Supply (Metal) Non-flammable Non-flammable Non-flammable Non-flammable HEPA Filter Seal Type:

Supply Filter-99.99% Eff. on 0.3 microns

HEPEX Seal- Neoprene, Spring-loaded

Optional Services, (total) position:

Service Coupling (3/8 inch NPT) Gas Valve/Service Coupling (3/8inch

NPT)

Outlet

(3) Right/left sidewalls

(2) Right/left sidewalls

(2) Right/left sidewalls

Work station Size Inches (mm):

Height Width Depth

58 (1473) 38 (965) 32 (813)

50 (1270)

62 (1575)

74 (1880) 32 (813)

Work Zone Inches (mm):

Height Width Depth (measured on work surface) Depth (measured at window access height)

30 1/8 (765) 33 7/8 (860) 26 3/4 (679) 24 7/8 (630)

45 7/8 (1165)

57 7/8 (1470)

69 7/8 (1775) 26 3/4 (679) 24 7/8 (630)

Airflow Volume at 90 fpm (.46 mps)

CFM/CMH #

718 (1220)

958 (1628)

1198 (2036)

1438 (2443)

Heat Rejected, BTU, Per Hour

863 1256

Electrical:

Volts, AC 60 Hz +Amps: Blower/Lights Rated Amps:

12 ft. Power Cord (one)

U.L./U.L.-C Listed 2.2 14 GA - 3 Wire, 15A

U.L./U.L.-C Listed 3.2 14 GA-3 Wire, 15A

U.L./U.L.-C Listed 4.2 14 GA-3 Wire, 15A

U.L./U.L.-C Listed 5.0 14 GA-3 Wire, 15A

Work station weights:*** Crated Shipping Weight Net Weight

340 lbs. /154 kg.

300 lbs. /136 kg.

405 lbs. /184 kg.

355 lbs. /161 kg.

470 lbs. /213 kg.

420 lbs. /191 kg.

565 lbs. /256 kg.

595 lbs. /270 kg.

# 10% of this value is recirculated *** Crated shipping weight does not include weight for accessories or options + Based on Work station with new filters running at 115VAC.

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5.0 Operating the NU-140

5.1 Aeromax™ Control System

5.1.1 Overview

The Aeromax™ control system is designed to service the control requirements of the AireGard™ ES NU-140. The Aeromax™ control system consists of an electronic module that will perform the following functions:

• Easy user interface via LED’s and function keys

• Control blower via solid state switch.

• Control lights via solid state switch.

• Disable audible alarm switch with ring back function.

• Control blower DC ECM motor/blower with solid-state DC Motor Controller that provides automatic compensation for line voltage variances.

• Monitor and display airflow system performance via PresurFlow™ monitor.

The AireGard™ ES NU-140 offers the latest digital microprocessor design technology for improved performance and safety. The Aeromax™ control system integrates a digital pressure sensor (PresurFlow™) to monitor the airflow performance. The Aeromax™ control system also integrates a DC ECM motor/blower controller that provides automatic compensation for both filter loading and line voltage variances. There is additional on/off control of blower and light. All the above functions are shown in a system block diagram (see figure 1).

Figure 1

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5.1.2 Front Panel

The control system front panel contains the following functions described in detail (see Drawing BCD-16521).

5.1.2.1 Blower Keys

The blower key controls the ON/OFF power to the blower.

LED above key indicates: full green for blower on, blinking green for blower pending and full red for blower alarm.

5.1.2.2 Hidden Key

The hidden key is located just above the blower LED indicator centered in the airflow symbol. The hidden key is used for various functions including the blower password 3 key sequence if the option is activated.

5.1.2.3 Fluorescent Light Key

The fluorescent light key controls the on/off power to the fluorescent light.

LED above the key indicates full blue for fluorescent light on.

5.1.2.4 Ultraviolet (UV) Light Key (optional)

The UV light key controls the on/off power to the UV light.

LED above indicates full yellow for UV light on.

5.1.2.5 Outlet Keys (only used for service/diagnostics)

The outlet key controls the ON/OFF power to the outlets.

LED above indicates full blue for outlets on.

5.1.2.6 Red Alarm LED

The red alarm LED will indicate any alarm condition and remain indicating until the alarm condition is cleared.

5.1.2.7 Audible Alarm Silence

The audible alarm silence key allows user interaction to silence an audible alarm for a period of 15 minutes.

After 15 minutes if the alarm condition still exists, the audible alarm will again sound.

The audible alarm silence key also is used to exit all Aeromax™ user interaction menus.

5.1.2.8 Arrow Adjustment Keys

The arrow adjustment keys allow user interaction for various functions.

5.1.3 Aeromax™ Control System Power

After the AireGard™ ES NU-140 is plugged into the appropriate facility line power the control system will power up.

The control panel will also indicate the power up status by blinking the red alarm LED. Pressing any key will acknowledge the power up status and turn off the blinking red alarm LED.

If a power interruption occurs, all control system functions, calibrations and parameters will be maintained and continue upon restoration of power. Just as the initial power up, the red alarm LED will blink to indicate power up status.

5.1.4 Standby Mode

When the NU-140 is not in use any of the function keys except the blower that initiates run mode may be turned on and off in standby mode.

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5.1.5 Run Mode

Any time the blower run key is pressed with the hinged window at its correct operational height, the RUN MODE screen will be initiated. The Run Mode will start with the PresurFlow™ entering and approximate 3 minute warm up period. The PresurFlow™ LED indicators will blink and indicate the following sequence:

• 1st minute – Left and right Red LED’s will blink

• 2nd minute – Left and right Green LED’s will blink

• 3rd minute – Center 3 Green LED’s will blink

Once the warm up period is complete, only one LED will indicate cabinet airflow status.

During the warm up period the cleaning process may begin.

5.1.6 Standby/Run Mode Alarms

If present, standby/run mode alarms will be both visual and audible, the red alarm LED oval will turn on. 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 list below represents alarm types and their respective priority from the highest to lowest priority.

1) New Firmware Loaded

2) Internal Board Failure

3) Power on Reset

4) Airflow Pressure Alarm

5) Blower RPM Failure

Note: The above messages are described in greater detail in section 7.

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5.1.7 Operator Accessible Functions

5.1.7.1 Access and Navigation

To access the operator accessible functions,

• Press and hold the key, then enter the 3 key sequence for the desired function, then release

The key and follow each instruction set.

Note: Pressing the key at any time will abort and exit the process without saving any changes made. Pressing the hidden key will accept all changes and exit.

5.1.7.2 Auto Timer Duration

Auto timer duration timers are countdown timers for the functions displayed once time is entered into a function. The timer will begin to countdown upon the start of that function (i.e. press light key to start timing the light). The LED indicator above the function key will start to blink indicating the timer function. If the LED indicator was full on, no timer function is present. As the timer expires the function will turn off.

• Select auto timer duration function o Outlets (Special option feature only)

Press and hold key, then press hidden – outlet – outlet keys sequentially.

LED indicator above outlet will blink fast. Adjust desired time as described below.

o Lights

Press and hold key, then press hidden – light – light keys sequentially.

LED indicator above light will blink fast. Adjust desired time as described below.

o UV Light (Diagnostic key use only)

Press and Hold key, then press hidden – UV light – UV light keys sequentially.

LED indicator above UV light will blink fast.

Adjust desired time as described below.

• Low Flow Blower (Diagnostic key use only)

Press and hold key, then press hidden-blower-blower keys sequentially.

LED indicator above Blower key will blink fast. Adjust desired time as described below.

o Adjust countdown time

Press ↑ or ↓ keys to adjust time.

Time will change in 15 minute increments as shown on the PresurFlow™ LED segments below.

15 minutes for Red LED 30 Minutes for Yellow LED

1 hour for green LED Represents 8 hours (maximum time)

• Press hidden key to accept time and exit.

• Press key at any time to abort and exit.

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5.1.7.3 Blower Password

The blower on/off password allows the cabinet user to place a 3 key sequence requirement to turn the blower on or off.

The 3 key sequence for the blower password will be a combination of the hidden and blower keys.

• Select blower password

Press and hold key, then press hidden – blower – hidden keys sequentially.

Red LED indicator above blower will blink fast.

• Select password Press ↑ or ↓ key to scroll through the code choices below, No Password

B-B-H password

B-H-B password (default)

B-H-H password only

H-B-B password

H-B-H password

H-H-B password

• Press hidden key to accept time and exit.

• Press key at any time to abort and exit.

Note: If the required blower password option is selected in the blower airflow option menu (see section 7.2.2).

Then the “No password” choice above is not available and the default remains B-H-B.

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5.2 Operating Guidelines

Operate the laminar flow workstation continuously. The unit will then remain in its initially clean condition. If, for any reason, the unit is turned off, turn the unit on and permit to operate for 5 minutes before resuming operations.

Allow only essential items in the work station. Objects should not be placed between the HEPA filter and any point where the clean environment must be maintained. New items introduced into the work area should be placed downstream of items already in the work zone for several minutes to allow contaminants to flush off. Note that plastic parts may carry a static charge which may require special handling in order to remove contaminants.

Particular care must be exercised in placing equipment within the work space. Where possible, equipment should be placed on perforated platforms to allow air movement under as well as around the object.

All work should be performed with the operator's hand or head downstream of the critical process points. Unnecessary movement with the work station should be kept to a minimum.

If the workstation is used in a manner not specified by NuAire, the protection provided by the equipment may be impaired.

5.2.1 Operating Sequence

A. Start Up Turn on workstation blower and lights, check air intake ports of the workstation to make sure they are unobstructed. The workstations are provided with gauges which indicate pressure differentials across the filters. They indicate when to replace the filters, dependent upon the blower fan capacity. Blower speed must only be readjusted by qualified maintenance technicians.

B. Good procedure includes the decontamination or wipe down of workstation surfaces with chemical disinfectant before work commences.

C. Allow blowers to operate for a minimum of 5 minutes before aseptic manipulations are begun in the workstation. An additional advantage is obtained from purification (filtration) of the room air circulated through the equipment. Because of the characteristic contributed to the quality of the laboratory environment, some owners leave them in operation beyond the time of actual use.

D. Minimize Room Activity - Activity in the room itself should be held to a minimum. Unnecessary activity may create disruptive air currents, as well as interfere with the work of the operator. A person walking past the front of the workstation can cause draft velocities up to 175 FPM, which are sufficient to disrupt the air balance of the Laminar Flow Unit.

E. Utilize Unidirectional Airflow - The operator must keep two important facts in mind:

1) The air, as supplied to the work area through the HEPA filter is contaminant-free.

2) Airborne contamination generated in the work area is controlled by the unidirectional flow of parallel air streams.

A solid object placed in a laminar air stream will disrupt the parallel flow and consequently, the capability of controlling lateral movement of airborne particulates. A cone of turbulence extends behind the object and laminarity of the air stream is not regained until a point is reached downstream, approximately equal to three to six times the diameter of the object. Within the parameters of this cone, particles may be carried laterally by multidirectional eddy currents.

5.3 Ergonomics

Ergonomics, the study or accommodation of work practices is extremely important for proper workstation usage and user health and safety. An evaluation of normal work practices should be performed with each user when working in a workstation. Evaluation criteria should be at a minimum:

a. Proper user posture

b. Effective workzone layout for work practice

c. Vision or sightlines

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For each of the above evaluation criterion, several aids may be supplied to accommodate the user.

• Ergonomic chair - A six-way articulating seat and back control for personalized adjustment to assure proper user posture. Be sure 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 workstation is provided with a 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 are optional that can provide support for particular work practices, such as pipetting.

• Effective workzone layout - Always prepare your work procedure to minimize reach to avoid neck and shoulder stress and fatigue. Rotating tables are optional to maximum workzone and minimize reach.

• Vision and sightline - Always prepare your work procedure to eliminate glare and bright reflections on the window.

Keep your window clean and sightlines clear to your effect workzone.

5.4 Cleaning Procedures

5.4.1 General

Cleaning laboratory equipment is important in terms of both functionality and general good housekeeping. The information provided below is intended to aid the development of facility Standard Operating Procedures (SOP’s) for cleaning the equipment. It is strongly recommended that all cleaning materials used be tested and verified in terms of both effectiveness and material compatibility before they are written into the cleaning SOP documentation.

a. The airflow blower should be operating during the cleaning process to maintain sterility and/or containment during the cleaning process.

b. Raise window to gain additional access if desired.

c. Apply appropriate cleaning material or surface disinfectant to surfaces. Most surface disinfectants require a specific contact time depending the materials used within the work zone. CONSULT APPROPRIATE DISINFECTANT

DOCUMENTATION FOR PROPER APPLICATION AND SAFETY PRECAUTIONS.

c-1. Polycarbonate (Covestro® Makrolon®AR) has noted material compatibility concerns (see polycarbonate compatibility section). They recommend the use of Hydrogen Peroxide based materials such as the following:

- Steriplex SD

- Safetec surface wipes

- Peridox RTU

It is recommended to AVOID the use of cleaning materials that contain Chlorine, Quaternary Ammoniums and Phenol’s.

If the polycarbonate is lightly scratched, it may be able to be polished out with Mirror Glaze Plastic Polish or similar.

Further information may be available from www.covestro.com c-2. Stainless steel (type 304) has noted material compatibility concerns with Acids, Chlorides and Halogens. IF THESE MATERIALS ARE USED AND ALLOWED TO BE LEFT ON THE STAINLESS STEEL SURFACE, OXIDATION AND DEGRADATION WILL OCCUR. Only by re-wiping surfaces with either sterile water or 70% IPA will remove harmful materials from the stainless steel surface.

Further information is available at the following: http://www.parrinst.com/wp-content/uploads/downloads/2011/07/Parr_Stainless-Steels-Corrosion-Info.pdf

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 known general source documents for use to develop application cleaning SOP’s.

NOTE: When cleaning the work area for the first several times, the new metal surfaces may produce some dark discoloration on the white cleaning wipes. Repeated cleaning will continuously reduce the amount of the discoloration material on the cleaning wipes over time.

http://www.covestro.com/ http://www.parrinst.com/wp-content/uploads/downloads/2011/07/Parr_Stainless-Steels-Corrosion-Info.pdf http://www.parrinst.com/wp-content/uploads/downloads/2011/07/Parr_Stainless-Steels-Corrosion-Info.pdf

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6.0 General Maintenance

All maintenance actions on this equipment must be performed by a qualified technician who is familiar with the proper maintenance procedures required for this equipment. This includes both certification as well as repair.

6.1 Fluorescent/LED Lamp Replacement

The two (T8) fluorescent bulbs or optional LED lamps are cool white and placed external to the cabinet to aid maintenance and minimize heat build-up within the cabinet. The life rating of the bulb is 9,000 for fluorescent and 50,000 hours for LED based on three-hour burning cycles.

To replace a lamp, it is necessary 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 reinstall the lamp assembly being careful not to pinch the safety straps, cable or tubing during closure of the control center.

6.2 HEPA Filter Replacement

The HEPA filter, under normal usage and barring an accident (puncture), does not need replacement until the efflux velocity cannot be maintained at 90 LFPM (.457 m/s) + 10%. This may permit the HEPA filter efflux average to be as low as 81 LFPM (.411 m/s), as long as no point falls below 70 LFPM (.355 m/s). Use only replacement filters of the same rated flow and size as originally installed to insure proper airflow and HEPA filter lifetime can be achieved.

The HEPA Filter replacement procedure is performed by the following steps: Drawing BCD-19998):

Disconnect electrical power from the cabinet before attempting any maintenance action.

1. Close the window to fully closed position.

2. Remove flush mount front panel by removing (2) .250 x .500 10-24 shoulder bolts (1 each side top and lower control box).

3. Remove front pressure panel by removing 8-32 screws along top and bottom of panel.

4. Remove the front screw and tension spring assemblies across the front of the plenum (3 places).

5. Tip the plenum up and hang from hook located center of top header on the top panel.

6. Lift front of HEPA filter and remove.

NOTE: This step usually requires 2 people for the removal and replacement of the HEPA filter.

7. Reverse procedure for installation and operation.

8. Reconnect unit power.

6.3 Pre-Filter Replacement

The replacement interval depends on the contaminant (large particles or lint) in the room -- a typical period is every 6 months. The prefilters are located on the top of the workstation.

6.4 Airflow Control System Setup and Calibration

6.4.1 General

The operation of the NU-140 requires that the setup and calibration procedures be performed in order to certify or commission for usage. The setup and calibration procedures performed ONLY BY THE CERTIFIER ensure that setpoints are verified and that the airflow monitor sensor is calibrated to the correct values.

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6.4.2 Configuration Parameters

Configuration parameters identify NU-140 motor type and size for proper performance characteristics.

• Select/Verify model and size (Bold items represent default parameters) o Press and hold key, then press blower – blower – blower keys sequentially.

LED indicates above both blower (red) and UV light keys will blink fast.

Review model type/size and change if desired as described below o Press ↑ or↓ keys to scroll through the LED segment choices associated with model type/size.

Class II, 3 foot

Class II, 4 foot

Class II, 5 foot

Class II, 6 foot

Laminar, 3/4 foot

Laminar, 5/6 foot o Press hidden key to accept model/size and exit o Press key at any time to abort and exit

• Select motor control function/type o Press and hold key, then press light – light – light keys sequentially.

LED indicators above both blower (red) and light keys will blink fast.

Review motor control function/type and change it desired as described below.

o Press ↑ or ↓ keys to scroll through the LED segment choices associated with motor control function/type.

Auto DC ECM motor

Fixed duty DC ECM motor

Fixed duty EC Impeller motor o Press hidden key to accept motor control function/type and exit o Press key at any time to abort and exit.

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6.4.3 Airflow Calibration

Failure to calibrate airflow to the specified requirements may result in unsafe conditions of performance (i.e. product protection, noise and vibration)

The NU-140 Airflow Calibration consists of adjusting the airflow.

THIS WORK SHOULD BE DONE ONLY BY A QUALIFIED TECHNICIAN WHO CAN MEASURE THE AIRFLOW WITH A SUITABLE VELOMETER. NuAire provides one adjustment to set the airflow within the cabinet.

This is: PWM signal adjust via calibration parameter menu.

The PWM signal or blower speed adjustment establishes the NU-140 total volume of airflow as well as makes up for filter resistance tolerances.

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 voltmeter. The two test points to measure DC ECM motor voltage are located on the DC motor connector on the main control board.

The NU-140 is considered to be certifiable if the following airflow measurements are present:

Inflow average: 90 LFPM + 10 LFPM (.46 m/s + 0.05 m/s) using the direct inflow measurement method or related value using the calculated inflow velocity measurement method.

BEFORE STARTING AIRFLOW CALIBRATION PROCEDURE, LET THE NU-140 RUN FOR AT LEAST 5 MINUTES.

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6.4.3.1 Airflow Calibration

Step 1: Measure the inflow velocity using the recommended procedure found in Table 6.0. If necessary, adjust to achieve the correct average miniflow velocity within the stated range of 90 + 10 LFPM (.46 + 0.05 m/s).

Step 2: If necessary, enter active blower speed adjustment.

• Press and hold key, then press hidden – blower - ↑ keys sequentially.

LED indicator above blower (green) key will blink fast.

Step 3: Press ↑ or ↓ keys to adjust blower speed.

• LED segments will indicate blower speed percentage and active blower speed adjustment o Right end red LED indicates active blower speed adjust The red LED will blink as soon as any adjustments are made and will continue to blink as the motor rpm settles. Once the red LED stops blinking, the motor will run steady state at the new percentage.

Note: The red LED must be non-blinking to save or exit o Green LED’s indicate percentage on of scale (0-100%) o Yellow LED’s indicate minimum (left/maximum (right) blower speed has been achieved

Note: At any time during the process

• Press hidden key to accept and enter the blower speed calibration point (If the blower speed calibration point was not successfully entered; a half second audible alarm will occur. The calibration process must then be repeated for successful entry of blower speed calibration point.)

• Press key to abort and exit

6.4.3.2 PresurFlow™ Alarm Set Points

The PresurFlow™ alarm setpoints are based on the calibration setpoint. Once the calibration setpoint is entered, based on a nominal inflow velocity of 90fpm (.46mls) the associated pressure sensor value is entered as the nominal pressure value. The high and low alarm setpoints are factory verified and set if needed at 90LFPM (.46 m/s).

However, if specific use alarm setpoints are desired, the alarm setpoints may be adjusted by performing the following:

Low Alarm Setpoint

• Press and hold the ↓ key for 3 seconds.

(The left red LED will blink and the green LED’s indicate blower speed)

• Press ↑ or ↓ keys to adjust blower speed to the desired airflow velocity low alarm setpoint value.

• Left end red LED indicates active low limit blower speed adjust

The red LED will blink as soon as any adjustments are made and will continue to blink as the motor rpm settles. Once the red LED stops blinking, the motor will run steady state ate the new percentage.

If the low alarm setpoint value is not within an acceptable range, the left end red LED will blink at a very fast rate.

Note: The red LED must be non-blinking to save or exit.

Note: At any time during the process

• Press hidden key to accept low alarm setpoint value

• Press and hold outlet key for three seconds to remove any previous offsets

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• Upon exiting, the blower will go back to actual airflows.

High Alarm Setpoint

• Press and hold the ↑ key for 3 seconds.

(The right red LED will blink and the green LED’s indicate blower speed)

• Press ↑ or ↓ keys to adjust blower speed to the desired airflow velocity high alarm setpoint value.

• Red end Red LED indicates active high limit blower speed adjust.

The red LED will blink as soon as any adjustments are made and will continue to blink as the motor rpm settles. Once the red LED stops blinking, the motor will run steady state at the new percentage.

If the high alarm setpoint value is not within an acceptable range, the right end red LED will blink at a very fast rate.

Note: The red LED must be non-blinking to save or exit.

Note: At any time during the process

• Press hidden key to accept low alarm setpoint value

• Press and hold outlet key for three seconds to remove any previous offsets

• Upon exiting, the blower will go back to actual airflows.

Note: Specific use alarm setpoints or the offset pressure value from the nominal calibration point will be maintained with a new nominal calibration value.

It is not necessary to re-enter the alarm setpoints after a nominal calibration.

6.4.3.3 PresurFlow Alarm Verification

The PresurFlow Alarm setpoints are based on the calibration setpoint. Once the calibration setpoint is entered, the Alarm setpoint offset pressure values will align from the calibration pressure value. The high or low alarm setpoint can be verified by measuring inflow volume/velocity while adjusting blower up or down within the Alarm Verification menu.

• Press and hold key, then press ↑ ↓ ↑ sequentially releasing the key after the 3 key sequence.

• Note: If blower was off while entering into the Alarm Verification Menu, the low alarm limit will immediately activate. Turn on blower; once airflow is above the low alarm limit, the alarm will turn off.

• LED segments will indicate blower speed percentage.

• Press ↑ or ↓ key to raise or lower blower speed. Alarm is active so yellow and red LED’s will activate if pressure reaches the low or high alarm limit.

• Press to exit (blower should turn off and not go through normal start up procedure).

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Table 6.0

Airflow Velocity Profile

A. Instruments: TSI 8355 Thermo anemometer B. Procedure:

Air velocity readings are taken on a 12 inch (305mm) grid, in a plane parallel to and 6 inches (152mm) from the diffuser.

No reading should be taken closer than 6 inches (152mm) from the inner edge of the filter frame.

C. Test Data:

Number of Readings: Average Velocity: ft./min. m/s

D. Acceptance Criteria:

1. Average Velocity = 80 to 100 fpm (.41 to .51 m/s)

2. Individual Readings must be within ±20 percent of the average velocity

__________ to __________ fpm (__________ to __________ m/s).

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6.5 HEPA Filter Leak Test

In order to check filter and filter seal integrity, the HEPA filter media and seals must be directly accessible, by the measuring instrument. The challenge material (i.e. PAO) should be supplied in the top panel of the workstation. An upstream challenge may be taken by using the minihelic gauge pressure supply tube if desired.

The diffuser is secured by thumb screws on the sides.

Once removed the diffuser can be lifted up slightly using the small handles and removed from the cabinet.

Model Size Filter Area (ft2)(m2)

330 5.59 (.519) 430 7.57 (.703) 530 9.55 (.887) 630 11.52 (1.07)

To measured 6 inches below the diffuser

Laskin Nozzle Concentration Formula

# Nozzles x 135 CFM x 100 ug/L Challenge CFM Concentration (ug/L)

# Nozzles x 229 CMH x 100 ug/L Challenge CMH Concentration (ug/L)

6.6 Cleanliness Classification Test for Pharmacy Application

If this cabinet is going to be used within pharmacy, per USP7971, the cabinet must be tested to assure compliance to ISO 14644-1:2015, Cleanrooms and Associated Controlled Environments, Part 1: Classification of Air Cleanliness2. The cleanliness classification test is performed using a particle counter to measure particle counts within the cabinet workzone.

Turn on cabinet and let warm up for several minutes. Turn on particle counter and flush out sample tubing line to remove latent particles. Set the particle counter to measure 0.5 micron or larger particles at the appropriate measuring rate.

“Operational Particle Count Test3” Position the particle counter isokinetic probe at a point 6 inches (152mm) upstream of the aseptic manipulation area (hand convergence point) and mounted so as not to interfere with the operator’s hand movement. The pharmacy operator will simulate IV manipulation during the particle count test 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 Vertical plane as measured approximately 6-inches (152mm) parallel to the diffuser. The grid location is designed as the diffuser center point and each corner measured 6-inches (152mm) from the inside perimeter.

Record the 5 particle count values for each of the test points over the 1-minute sample time. All final count particle concentrations and calculated 95% upper confidence limit shall not exceed 3520 particles per cubic meter (ppcm) or (100 particles per cubic feet (ppcf).

1 USP28-NF23: United Stated Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852, USA, www.usp.org.

2 ISO 14644-1:2015 Cleanrooms and Associated Controlled Environments-Classification of Air Cleanliness, International Organization for Standardization, Case Postale 56, CH-1211 Geneve 20, Switzerland

3 CAG-002-2006: CETA Compounding Isolator Testing Guide, Controlled Environment Testing Association, 1500 Sunday Drive, Suite 102, Raleigh, NC 27607, USA, www.cetainternational.org http://www.usp.org/ http://www.cetainternational.org/

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6.7 Main Control Board Description and Replacement

To access the main control board for fuse or board replacement, remove (1) rear screw at each top side of the top panel and pull out panel to access. Now the main control board is exposed for service.

6.7.1 Main Control Board Replacement

The main control board consists of one Printed Circuit Board (PCB) assembly.

The PCB contains the power supply, configuration switch, sensor inputs/outputs and control inputs/outputs components and display.

6.7.2 Main Control Board Fuse Replacement

Disconnect electrical power before fuse replacement.

All AC circuits are fuse protected and when replacement is necessary, USE ONLY FUSES OF SAME TYPE AND RATING

FOR PROTECTION AGAINST RISK OF FIRE.

DESCRIPTION: BLOWER FUSE OUTLET FUSE

(Option Only)

ACCESSORY OUTPUT FUSE

(Option Only) LIGHT FUSES

FUSE TYPE: TIME-LAG TIME-LAG TIME-LAG TIME-LAG

FUSE SIZE: 1/4 X 1-1/4 INCH 5 X 20MM 5 X 20MM 5 X 20MM

NU-140-330 8 AMPS 3 AMPS 2 AMPS 1 AMP (2)

NU-140-430 10 AMPS 3 AMPS 2 AMPS 1 AMP (2)

NU-140-530 10 AMPS 3 AMPS 2 AMPS 1 AMP (2)

NU-140-630 10 AMPS 3 AMPS 2 AMPS 1 AMP (2)

6.7.3 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 replacement, it would be preferred to know the operational parameters of the cabinet, (i.e. blower speed/PWM signal DC voltage setpoints if modified and airflow data from previous certification).

Disconnect electrical power before attempting any maintenance action.

The main control board is fastened to the control center with (6) 6-32 studs/nuts. All electrical connections are made with removable terminals and/or Faston connectors except…