Innovaprep Cp select User manual

Table of Contents

1 PRODUCT OVERVIEW .............................................................................................................................................................. 4

1.1 PRODUCT DESCRIPTION ................................................................................................................................................................. 4

1.2 APPLICATIONS .............................................................................................................................................................................. 4

1.3 DEVICE SPECIFICATIONS ................................................................................................................................................................. 4

1.4 ACCESSORIES INCLUDED WITH THE CP SELECT .................................................................................................................................... 5

2 CONCENTRATING PIPETTE METHOD OF OPERATION ............................................................................................................... 7

2.1 CONCENTRATION PROCESS ............................................................................................................................................................ 7

2.2 WET FOAM ELUTION ..................................................................................................................................................................... 8

2.3 FOAM GENERATION ...................................................................................................................................................................... 8

2.4 CP FILTER TIPS ............................................................................................................................................................................. 8

3 COMPONENTS OF THE CONCENTRATING PIPETTE ................................................................................................................. 10

4 INSTALLATION OF THE INSTRUMENT COMPONENTS ............................................................................................................. 13

4.1 INSTALLING THE POWER SUPPLY .................................................................................................................................................... 13

4.2 INSTALLING AND REMOVING THE PERMEATE LINE TUBING .................................................................................................................. 13

4.3 INSTALLING THE STORAGE FLUID AND FLUID ADAPTER ....................................................................................................................... 13

4.4 INSTALLING AND REMOVING AN ELUTION FLUID CANISTER ................................................................................................................. 14

4.5 INSTALLING AND REMOVING CONCENTRATING PIPETTE TIPS ............................................................................................................... 15

5 NAVIGATING THE MENU ....................................................................................................................................................... 16

5.1 THE MAIN MENU ....................................................................................................................................................................... 16

5.2 THE RUN PROTOCOL MENU ......................................................................................................................................................... 16

5.3 THE MAINTENANCE MENU ........................................................................................................................................................... 17

5.4 THE INSTRUMENT SETTINGS MENU ................................................................................................................................................ 17

6 MAINTENANCE PROCEDURES ............................................................................................................................................... 18

6.1 STARTING UP THE INSTRUMENT FOR THE FIRST TIME ........................................................................................................................... 18

6.2 THE START UP PROCEDURE .......................................................................................................................................................... 19

6.3 THE SHUT DOWN PROCEDURE ...................................................................................................................................................... 19

6.4 PRIMING THE ELUTION FLUID ........................................................................................................................................................ 20

6.5 PREPARING THE INSTRUMENT FOR TRANSPORT OR SHIPMENT ............................................................................................................. 20

6.6 RECOMMENDED GENERAL MAINTENANCE FOR CP SELECT .................................................................................................................. 22

7 PERFORMING A SAMPLE CONCENTRATION RUN ................................................................................................................... 23

7.1 CONTROLLED COLLECTION OF PERMEATE ........................................................................................................................................ 23

8 CONCENTRATION RUN PROTOCOLS ...................................................................................................................................... 25

8.1 STD. OPTIONS ............................................................................................................................................................................ 25

8.2 ADV. OPTIONS ........................................................................................................................................................................... 25

8.3 DEFAULT CONCENTRATION RUN PROTOCOLS ................................................................................................................................... 26

8.4 SELECTING A PROTOCOL ............................................................................................................................................................... 27

8.5 CREATING A CUSTOM PROTOCOL ................................................................................................................................................... 27

8.6 EDITING A CUSTOM PROTOCOL ..................................................................................................................................................... 28

8.7 DELETING A PROTOCOL ................................................................................................................................................................ 28

8.8 PASSWORD PROTECTION .............................................................................................................................................................. 28

8.9 CONCENTRATING PIPETTE OPERATION CHECK LIST ............................................................................................................................ 29

9 TIPS AND SUGGESTIONS ....................................................................................................................................................... 30

10 SAFETY PRECAUTIONS ...................................................................................................................................................... 30

11 CONCENTRATING PIPETTE SUPPLIES ................................................................................................................................. 32

12 CHEMICAL COMPATIBILITY GUIDE .................................................................................................................................... 34

13 CUSTOM PROTOCOL RECORDS ......................................................................................................................................... 36

14 REVISION HISTORY ........................................................................................................................................................... 37

1 PRODUCT OVERVIEW

This Section contains a product description of the InnovaPrep Concentrating Pipette Select and a brief look at its

applications.

1.1 PRODUCT DESCRIPTION

The InnovaPrep Concentrating Pipette Select (CP Select), shown in Figure 1.1, quickly and efficiently concentrates particles

of interest from large liquid sample volumes into liquid volumes as small as 200 microliters (smaller volumes are attainable

in some applications). The CP Select uses a novel elution method to recover particles that have been captured onto a

disposable porous membrane filter with high recovery efficiencies.

FIGURE 1.1 INNOVAPREP CONCENTRATING PIPETTE SELECT

1.2 APPLICATIONS

The patented InnovaPrep concentration technology (US Patents 8,110,112; 8,584,535; 8,758,623; 9,593,359; 9,574,977;

9,738,918; D688,805; and other patents awarded and pending - see www.innovaprep.com/patents) has application

anywhere that enrichment of low concentrations of particles is needed. The primary area of application is for preparing

and concentrating particles of biological origin, including pathogens in liquid samples, for subsequent analysis by

traditional microbiological methods, such as plating, or with rapid molecular analytical devices.

1.3 DEVICE SPECIFICATIONS

Dimensions 13 in x 11 in x 7 in

Weight 8 lbs.

Input Power 100-240VAC 50/60 Hz, 1.5 Amps

Output 12VDC @ 3.0 Amps

1.4 ACCESSORIES INCLUDED WITH THE CP SELECT

An image and list, including part numbers, of the accessories that are provided with the CP Select is provided below.

FIGURE 1.2 ACCESSORIES

• AC Power Cord and Power Supply – North America and 12V Power Supply (HC03019, HC03093) - Power supply

for CP Select. See Section 4.1 (Power Cord available for North America (HC03019), EU (HC03208), and UK

(HC03209).

• Tubing Clip (HC08017) – Keeps permeate line secure to waste container.

• Permeate Line (HC08006) – Directs filtered fluid to waste container. See Section 4.2.

Alcohol Prep Pads

Maintenance Tip

11 µm Nylon Syringe

Filter 25mm

Power Cord

Permeate Line

Tubing Clip

Filterless Tip

Silicone Lubricant

Storage Fluid Adapter

• Silicone Lubricant (HC08535) – Used for required, periodic lubrication of O-rings in the Tip Interface Port. See

Section 4.5.

• Storage Fluid Adapter (HC08560) – Connects storage fluid bottle, required in daily Shut Down maintenance

procedure. See Section 4.3.

• Maintenance Tip (HC08005) – This reusable tip is inserted into the Tip Interface Port during the Start Up, Shut

Down and Prime maintenance procedures. DO NOT USE WITH THE ELUTE OR RUN PROTOCOL-DAMAGE CAN

OCCUR TO THE INSTRUMENT. See Section 6.

• Alcohol Prep Pads (HC08529) – Used for periodic cleaning of the tip and elution fluid ports.

• Filterless Tip (HC08524 - M) – Used for alternate cleaning and maintenance procedures. Also, for

troubleshooting and diagnostic procedures when consulting with InnovaPrep Technical Support Engineers.

Keep on hand.

• 11 µm Nylon Syringe Filter 25mm (HC08533) – Used for alternate cleaning and maintenance procedures.

2 CONCENTRATING PIPETTE METHOD OF OPERATION

The InnovaPrep concentration process uses dead-end filtration to capture particles onto the surface of a porous

membrane filter. A novel Wet Foam Elution™ process is then employed to wash the particles off of the membrane surface

into very small liquid volumes.

2.1 CONCENTRATION PROCESS

The concentration process of the CP Select requires single-use

Concentrating Pipette Tips (CPTs). The Pipette tips have internal filter(s)

made with either a flat membrane or a bundle of hollow fiber membranes.

The sample is drawn through the CPT, and once all the fluid has passed, it

elutes the concentrated particles through the sample port of the filter tip.

The sample is prevented from coming in contact with the instrument

fluidics, decreasing the need for between-sample decontamination and

eliminating cross-contamination or “carryover”.

The filters are hydrophilic, meaning that air is allowed to flow through only

when the membrane is dry. Once the filter has been wetted, the surface

tension of the liquid trapped in the pores of the membrane prevents air

(or any other gas) from passing through the membrane. Thus the CPTs

cannot be re-used since air trapped inside the housing cannot be pulled

through the filter prior to processing a second sample.

The concentration process is performed in the following steps:

1. The main pump draws a vacuum on the Permeate Port. The air inside

the filter housing is drawn out and the liquid sample is pulled up through

the Sample Port.

2. As the sample is drawn through the filter, particles larger than the

chosen membrane pore size are captured on the pores; while liquids,

dissolved solids and particles smaller than the chosen pore size pass

through the filter and into the permeate.

3. Once the sample container is empty, air is drawn up behind the

liquid and the membrane “locks up”; leaving only the target particles on

the membrane and ending the run.

4. When the user performs an elution, InnovaPrep’s patented Wet Foam Elution™ process is utilized. The Permeate

Port valve closes and the elution valve opens, allowing the foam to enter the Elution Port. The foam travels

tangentially down the surface of the membrane as it washes the particles from the surface. The concentrated

sample is then pushed out of the sample port into a cuvette or other container where the foam quickly breaks

back down into a small liquid volume.

Elution Port

Permeate Port

Flat

Membrane

Tip

Hollow

Fiber

Tip

FIGURE 2.1 FLAT AND HOLLOW FIBER

CONCENTRATING PIPETTE TIPS

2.2 WET FOAM ELUTION

The Wet Foam Elution process is much more efficient than liquid rinsing for the following reasons:

Volume Expansion

When rinsing a filter with liquid, most of the liquid volume is used to fill the dead space inside the filter housing; or

inner bore of the membrane for hollow fiber tips. Thus, only a small portion of the fluid is actually in contact with the

filter surface. This can be minimized to an extent by reducing the cross-sectional area of the fluid path across the filter,

but a large portion of the liquid is still underutilized. Foam, however, is 80-90% gas, which fills the empty space without

contributing to the final sample volume.

Increased Viscosity

Liquid has a tendency toward “channeling” when flowing across a surface; that is, there is an area of high flow in the

center of the fluid path while the portion of flow in contact with the filter surface is much slower. The higher viscosity

of foam prevents channeling and creates a more uniform flow across the filter surface.

Bubble Dynamics

The micro-bubbles in the foam behave as deformable solids. As they travel across the surface of the filter they move

as a rigid body with a narrow lubricating layer, effectively squeegeeing the particles off of the surface.

Exfoliating Action

As the micro-bubbles in the foam impact against each other and burst, the turbulence and energy produced helps to

lift particles that are adhering to the membrane.

2.3 FOAM GENERATION

The Wet Foam Elution™ process requires very specific high-quality foam in order to be effective. The elution fluid is

composed of water, a low concentration surfactant (usually less than 0.1%), and a pH buffer. This solution is carbonated

with carbon dioxide (CO2) gas. During the elution process, the fluid passes through a valve to a low pressure environment,

causing the dissolved CO2 to expand and come out of solution to form microbubbles. These micro-bubbles increase the

volume of the fluid sixfold or more.

An additional benefit of Wet Foam Elution is the clean buffer exchange. In many situations, the starting sample matrix is

not the most desirable for the chosen analysis method. Wet Foam Elution allows the user to select the fluid that the

particles will be suspended in after concentration, which reduces inhibition and maximizes the chances of detection.

2.4 CP FILTER TIPS

For selecting the proper CPT please refer to the filter selection matrix presented in Table 2.1.

TABLE 2.1 CONCENTRATING PIPETTE SELECTION GUIDE

Part Number

Filter Tip

Media Type

Pore Size

Membrane

Surface Area

cm2

Input Sample

Volume (Varies

by Matrix)

Final Concentrated

Sample Volume

(User Selectable)

Processing Rate

(Varies by Matrix)

mL/min

Notes

CC08000-10

Flat Membrane

Polycarbonate

Track Etch

0.4 μm

8.5

Up to 1 Liter*

200 - 1000 μL

Up to

100 mL /min.

Recommended for concentrating bacteria,

whole cells, spores, pollen, and parasites from

food and beverage matrices or samples

containing proteins and polysaccharides

CC08001-10

Flat Membrane

Polyethersulfone

0.1 μm

8.5

Up to 1 Liter*

200 - 1000 μL

Up to

100 mL /min.

Recommended for concentrating bacteria,

whole cells, spores, pollen, and parasites from

environmental samples

CC08018-10

Hollow Fiber

Polysulfone

0.45 μm

Up to 5 Liters*

150 - 1000 μL

Up to

150 mL/min

Recommended for concentrating bacteria,

whole cells, spores, pollen, and parasites from

high fouling matrices

CC08022-10

Hollow Fiber

Polysulfone

0.2 μm

Up to 5 Liters*

150 - 1000 μL

Up to

150 mL/min

Recommended for concentrating bacteria,

whole cells, spores, pollen, and parasites from

all sample types

CC08020-10

Hollow Fiber

Polysulfone

0.05 μm

Up to 3 Liters*

150 - 1000 μL

Up to

90 mL/min

Recommended for virus concentration. The

addition of Tween 20 to the sample is

recommended to aid recovery efficiency (add

10% solution of Tween 20 in a 1/100 ratio to

the sample)

CC08003-10

Hollow Fiber

Polysulfone

Ultra -

Filtration

Up to 500 mL*

150 - 1000 μL

50 mL/min with

Tween 20

* With regards to starting sample volume, it is recommended that the entire sample should be processed within 30 minutes. It has been observed that there is a reduction

in the recovery when processing times exceed 30 minutes. The recommended upper-end run volume as shown in the concentrating pipette tip selection guide and time of

30 minutes is a general recommendation and may be dependent on sample matrix and target organism. See Section 10 for full part number list.

3 COMPONENTS OF THE CONCENTRATING PIPETTE

The following Section describes the components of the InnovaPrep Concentrating Pipette Select.

FIGURE 3.1 CONCENTRATING PIPETTE COMPONENTS - RIGHT SIDE

Fluidics Head – This component contains the bulk of the fluidic components in the instrument. The Head can be raised

and lowered to position the Concentrating Pipette Tip in the sample container. LED lights in the head will glow blue

when the instrument is on, red when the instrument is concentrating and green when the instrument is eluting.

Tip Interface Ports – This is the point of installation for the consumable Concentrating Pipette Tips. The foam Elution

Port is in front where the foam is introduced into the tip at the time of elution. The sample fluid exits the rear Permeate

Port during a sample run.

Concentrating Pipette Tip (CPT) – This consumable component is the only part of the instrument that will come in

contact with the sample.

Canister Latch – This latch holds the Elution Fluid canister in place.

Fluidics Head

Tip Interface Ports

Single-use Pipette Tip

Sample Platform

Control Panel

Canister Latch

Elution Fluid (Foam) Canister

Canister Interface Port

Storage Fluid w/

Adapter Set

Maintenance Tip

Elution Fluid (Foam) Canister – Each canister contains enough elution fluid for up to 30 elutions.

Maintenance Tip – This reusable component is installed in the Tip Interface Port during the Start Up, Shut Down, and

Prime Maintenance Protocols. It is stowed on the bracket located on the right side of the instrument. DO NOT USE

WITH THE ELUTE OR RUN PROTOCOL - DAMAGE CAN OCCUR TO THE INSTRUMENT.

Storage Fluid with Adapter – This assembly is for use with the Shut-Down protocol. It conveniently stows on the

bracket located on the right side of the instrument.

Canister Interface Port – This spring-loaded port keeps the proper pressure on the valve of the fluid canister

(sometimes referred to as Can); it contains a check valve, which keeps the instrument pressurized when changing

canisters. The Storage Fluid Adapter also interfaces with this port during the Shut Down Maintenance Protocol.

Control Panel – The LCD display is navigated by the Up ( ▲ ), Down ( ▼ ), and Enter (

⏎

) keys. Certain menus may

also be entered by pressing and holding Enter (

⏎

) down for approximately 1 second.

Sample Platform – The sample container is placed here during sample processing.

Tension

Knob

USB Port

Power Switch

12V DC Power

Jack

Permeate Line Port

FIGURE 3.2 INSTRUMENT COMPONENTS – LEFT SIDE

Tension Knob – This knob is used to adjust the tension on the positioning arms for the Fluidics Head.

USB Port – A standard 'Micro-B' USB cable can be connected to the instrument from a computer to download periodic

software updates from the manufacturer.

12V DC Power Jack – Port for the included power supply.

Power Switch – The up position ( | ) turns the instrument on and the down position ( ¡ ) turns the instrument off.

Permeate Line Port – This quick connect fitting is where the filtered fluid (Permeate) exits the instrument. This port is

valved to prevent fluid from being pumped out without the permeate tubing attached.

4 INSTALLATION OF THE INSTRUMENT COMPONENTS

This Section will guide the user through setting up the instrument.

4.1 INSTALLING THE POWER SUPPLY

Plug the power cord and power supply together, plug the power supply into the 12VDC port on the side of the unit, then

plug the power cord into an available power outlet. It is not necessary to select the correct voltage; the sensor accepts

line voltage of 100 to 240 VAC, 50-60 Hz, single phase. The connection is self-regulating. WARNING: DO NOT USE ANY

POWER SUPPLY OTHER THAN THE ONE SUPPLIED WITH THE CP SELECT INSTRUMENT-DOING SO MAY CAUSE DAMAGE TO

THE INSTRUMENT AND VOID THE WARRANTY. (NOTE: THE POWER SUPPLY FOR THE PREVIOUSLY RELEASED CP - 150

CONCENTRATING PIPETTE INSTRUMENT IS NOT COMPATIBLE WITH THE CP SELECT)

4.2 INSTALLING AND REMOVING THE PERMEATE LINE TUBING

Included with the instrument is a Section of clear PVC tubing with a right angle quick connect fitting; this is the permeate

line tubing. To install the Permeate Line, first make sure that the metal button on the Permeate Port is pushed down on

the instrument. Then, insert the quick connect fitting on the Permeate Line into the

Permeate Port. When the fitting is fully seated the metal button will pop up, thus

locking it in place. Place the open end of the permeate line tubing into a waste

container of adequate volume relative to your sample volume.

To remove the Permeate Line, simply

press the metal button on the

Permeate Port and it will be released.

4.3 INSTALLING THE STORAGE FLUID AND FLUID ADAPTER

A daily Shut-down Maintenance Procedure is described in Section 6.3. The

procedure requires the use of the following items:

• Storage Fluid (HC08558)

• Reusable Storage Fluid Adapter (HC08560)

• Reusable Maintenance Tip (HC08005)

These items are conveniently stowed on a bracket on the right side of the

instrument as pictured at right in Figure 4.2. Figure 4.4, below, provides a

closer view of the Storage Fluid and Storage Fluid Adapter.

To install the Storage Fluid Adapter, remove the orange rubber cap (save for later use-used for transport and shipping)

from the Canister Interface Port and clean the port using an Alcohol Prep Pad. Remove the sealed cap from the Storage

Fluid bottle, and install the metal sipper tube portion of the Fluids Adapter into the bottle. The metal portion of the

assembly can be adjusted up or down in the bung to reach the bottom of the fluid bottle by loosening the fitting located

on the top of the bung. The Bung can now clip onto the bracket as shown, with the Fluids Adapter tubing clipped into the

bracket behind the bottle. The Maintenance Tip also stows on the bracket in the 1st position. See Section 6 for detailed

instructions for use.

FIGURE 4.2 STORAGE FLUID BRACKET

FIGURE 4.1 PERMEATE LINE

INSTALLATION

4.4 INSTALLING AND REMOVING AN ELUTION FLUID CANISTER

To install an elution fluid canister into the instrument, first hold the canister with the valve

pointing down. Then place the canister valve into the Canister Interface Port located on

the right side of the instrument. Now press the canister down and hook the edge under

the Canister Latch as shown in Figure 4.5.

REMOVING A FLUID CANISTER

To remove an Elution Fluid Canister, push down on the top of the canister pulling it away

from the instrument to unlatch.

When the instrument is new, the elution fluid canister valve will tend to stick in the Canister

Interface Port. Simply grab the canister with your hand and press your thumb against the

Canister Latch to leverage it up and out of the Canister Interface Port.

If a canister is removed before it is completely empty, a small amount of fluid (approximately 100 µL) may be expelled

from the can, this is normal.

The Canister Interface Port is the first place where contamination can enter the instrument's fluidics. Never let dust or dirt

enter the port and use good lab practices to prevent bacterial contamination. This would include not touching the stem

of the Elution Fluid Canister, the storage fluid interface fitting, or the Canister Interface Port with fingers or other non-

sterile objects. Protect the Canister Interface Port from contaminants by leaving the Storage Fluid Adapter connected to

the port when the instrument is not in use. Utilize the protective orange cap (HC03173) included with the unit for long

term storage. Clean the Canister Interface Port using an Alcohol Prep Pad prior to installing a new elution fluid canister.

FIGURE 4.4. STORAGE FLUID AND

STORAGE FLUID ADAPTER

FIGURE 4.3 STORAGE FLUID AND STORAGE FLUID

ADAPTER STOWED ON CP SELECT BRACKET

FIGURE 4.5 INSTALLING AND

REMOVING FLUID CANISTERS

4.5 INSTALLING AND REMOVING CONCENTRATING PIPETTE TIPS

Figure 4.6 shows how the CPT ports are aligned with the ports in the Fluidics Head.

FIGURE 4.6 TIP INTERFACE PORT DETAIL

To install a CPT, first raise the Fluidics Head all the way up. The two ports on the top of the CPT are different sizes; the

larger port is the permeate port facing the rear of the instrument. The CPT can only be installed one way and should slide

easily up into the ports on the underside of the Fluidics Head. When the CPT is fully seated, you should feel it "click” into

place. You can also verify that that the CPT is fully seated by looking through the clear fluidics manifold.

The rubber O-rings in these ports should be occasionally lubricated with the Silicone lubricant (item HC08535-20), provided

with the instrument, to maintain a tight seal. With a gloved finger, rub a very thin layer of lubricant on both ports of the

Maintenance Tip periodically (monthly) to ensure the O-rings remain flexible and leak free.

To remove the CPT, grasp it with your hand then use your thumb to press up on the underside of the Fluidics Head. The

"thumbs up" technique eliminates the need to hold the Fluidics Head with your free hand while you pull down on the CPT.

5 NAVIGATING THE MENU

This Section will guide you through the instrument's LCD menu instrument on the Control Panel. The three keys on the

right side of the Control Manual (symbols for Up ( ▲ ), Down ( ▼ ), and Enter (

⏎

), as shown in Figure 5.1) are used to

navigate the menu.

5.1 THE MAIN MENU

When the instrument is first turned on, a Welcome screen will be displayed as soon as the unit boots up (about 5 seconds).

Press Enter (

⏎

) to continue to the Main Menu screen.

The Main Menu consists of three selections: Start Run, Maintenance, and Instrument Settings.

5.2 THE RUN PROTOCOL MENU

Selecting Start Run from the Main Menu will display the Run Protocol screen. This screen displays:

Foam Volume Gauge (E = empty / F = full)

Last Run process time (mm:ss)

Name of the selected concentration run protocol (defaults to FLAT)

Start Run

Return

• Selecting the named protocol (FLAT) will navigate to the Protocol Setup screen where another protocol can be

selected, created (see Section 8.5 Creating and Saving a Concentration Run Protocol), or deleted. There are three

protocol options that have been preprogrammed by the factory named FLAT, HOLLOW, and ULTRA. These have

been named according to the three main types of CPTs available for use with the instrument: FLAT for use with

the flat CPTs (items CC08000 and CC08001), HOLLOW for use with the hollow fiber tips (items CC08018, CC08022,

CC08020), and ULTRA for use with the ultrafilter tips (item CC08003). See Table 2.1 CPT Selection Guide for a full

description.

• Selecting Start Run on the Run Protocols screen will immediately start the sampling process using the sample

protocol notated above.

• Return will lead back to the Main Menu.

Up ( ▲ )

Enter (

⏎

)

Down ( ▼ ),

FIGURE 5.1 MAIN MENU DISPLAY

FIGURE 5.2 RUN PROTOCOL

DISPLAY

5.3 THE MAINTENANCE MENU

Selecting Maintenance from the Main Menu will display instrument procedures (see Section 6 Maintenance

Procedures):

Start Up

Shut Down

Prime

Elute

Return

• Selecting Start Up will take the user through a series of prompts for the daily Start Up procedure (see Section

6.2 Start Up Procedure).

• Selecting Shut Down will take the user through a series of prompts for the daily Shut Down procedure (see

Section 6.3 Shut Down Procedure).

• Prime is for priming the elution fluid lines when a new elution fluid canister is installed in the unit. This

ensures that there is no air in the fluid path (see Section 6.4 Priming the Elution Fluid).

• Elute performs a foam elution according to the current instrument settings. This can be used at any time to

test the elution settings (see Section 8 The Elute Function).

• Return will lead back to the Main Menu.

5.4 THE INSTRUMENT SETTINGS MENU

There are seven instrument settings. A description of each are listed below:

• Beep volume changes the volume of the beeps that occur at the end of concentration cycles and elutions.

The four options are low, med., high, and off. Default = low

• Power LED turns the blue LED light in the Fluidics head on and off. Default = on

• Run LED turns the flashing red LED light in the Fluidics head on and off. Default = on

• Elute LED turns the flashing green LED light in the Fluidics head on and off. Default = on

• Set Password allows the user to set a password that must be entered before a custom protocol can be

created, modified, or deleted.

• Protocol allows the user to set the instrument to standard (Std) or advanced (Adv) options. If set to Std, the

user will have access to two standard set points - Valve Open and Pulse Count. If set to Adv, the user will

have access to 11 advanced settings during Protocol Creation. Once set, the options are accessed in the

Protocol Setup menu under Create Protocol. Default = Std

• Fluid Gauge turns the Elution Fluid Volume gauge on and off. Default = on

• Return will return you to the Options menu.

FIGURE 5.3 MAINTENANCE DISPLAY

6 MAINTENANCE PROCEDURES

This Section will guide the user through the daily maintenance procedures including how to perform the Start Up and Shut

Down routine and priming the elution fluid. Section 6.1, below, provides a Start Up procedure for the first time the

instrument is used. Sections 6.2 and 6.3 provide the standard Start Up and Shut Down procedures which should be

followed at the start and end of each day of use. Sections 6.4 and 6.5 describe the Prime and Elute functions. The

operation check list below, and also found in Section 8.9, should be performed before the first use and can be performed

any time if there is a question about the function of the instrument.

To ensure that the Concentrating Pipette was not damaged during shipping, the following procedure can be performed.

1. Check for pressure leak:

a. Insert Maintenance Tip, Elution Fluid Canister and Permeate Line. Insert the end of the Permeate Line in

water and Start Run.

b. Check that no bubbles are seen exiting the Permeate Line between 4 and 10 seconds.

2. Check Canister Interface Port and prime CP unit:

a. Insert an Elution Fluid Canister into the Canister Interface Port and check for leaks.

b. From the Main Menu select Maintenance>Prime and follow the menu prompts. Check for production

of foam.

c. Remove Elution Fluid Canister.

d. Ensure there is no leakage from the Canister Interface Port.

e. Re - install Elution Fluid Canister.

3. Check flow rate:

a. From the Run Protocols menu select FLAT.

b. Using the Filter-less Tip provided with the instrument, perform a 200 mL distilled water concentration

run. The run time should not exceed 1:30.

c. Perform an elution.

4. Look inside the head of the unit and check for any visible fluid leaks or moisture inside the head.

Failure in any of the above tests indicates a return of the Concentrating Pipette for repair may be necessary.

6.1 STARTING UP THE INSTRUMENT FOR THE FIRST TIME

Step 1 – Remove the instrument from the box and packaging. Place on a clean surface and

remove the orange rubber cap from the Canister Interface Port.

Step 2 – Follow instructions for installation of the instrument components as described in

Section 4: Install Power Supply (Section 4.1) and Permeate Line (Section 4.2), and stow the

Storage Fluid and Adapter in the bracket on the right side of the instrument (Section 4.3).

Step 3 – Power instrument on.

FIGURE 6.1

MAINTENANCE TIP

Step 4 – Advance to the Main Menu by pressing Enter (

⏎

) on the control panel.

Step 5 – Select Maintenance>Prime

Step 6 – Follow the menu prompts: Place the Maintenance Tip into the Tip Interface Port as

shown in Figure 6.1 using the same procedure described in Section 4.5 for installing a CPT.

Select Continue.

Step 7 – Follow the menu prompt: Place Foam Can (Elution Fluid Canister) Into Position. Use

the installation instructions described in Section 4.4. Make sure the open end of the

permeate line is secured in a waste container. Select Continue. The instrument will purge

elution fluid from the canister through to the permeate. The instrument is now ready for use.

6.2 THE START UP PROCEDURE

Biological contaminants or salts from evaporated elution fluid can be damaging to the instrument if they are allowed to

produce particles large enough to clog the fluid path. The daily Shut Down and Start Up Maintenance Protocol is used to

clean and flush contaminants from the fluid path of the instrument.

The Start Up Procedure is accessed by selecting Main Menu > Maintenance > Start Up. The selection will guide the user

through a series of prompts. The prompts assume the user followed the Shut Down procedure, following the last

instrument use, which instructs the user to leave the Storage Fluid Adapter installed in the Canister Interface Port.

Step 1 – Ensure the required instrument components have been installed: Power Supply (Section 4.1), Permeate

Line (Section 4.2), Storage Fluid and Adapter (Section 4.3).

Step 2 – Power instrument on. Advance to the Main Menu by pressing Enter (

⏎

) on the control panel.

Step 3 – Select Maintenance>Start Up

Step 4 – Follow the menu prompt: Place the Maintenance Tip into Tip Interface Port as shown in Figure 6.1 using

the same procedure described in Section 4.5 for installing a CPT. In practice, the Maintenance Tip should already

be in position in most cases, because it should be in place during periods of non - use. Select Continue.

Step 5 – Follow the menu prompt: Remove Storage Fluid Line from Can Interface Port. Cap the adapter fitting

and stow the tube set in the notch on the storage bracket as shown in Figure 4.3. Double check that the open

end of the permeate line is secured in a waste container. Select Continue. The instrument will purge the storage

fluid from the instrument’s fluidics. NOTE: DO NOT INSTALL AN ELUTION FLUID CANISTER UNTIL PROMPTED TO

DO SO IN STEP 6.

Step 6 – Follow the menu prompt: Place Foam Can into Position (see Section 4.4). Select Continue. The

instrument will prime the foam line with elution fluid. The instrument is now ready for use.

6.3 THE SHUT DOWN PROCEDURE

It is important to perform the Shut Down procedure at the end of each day of operation for the maintenance of the

instrument. The Shut Down procedure performs two important functions, instrument decontamination and the

prevention of salt crystals forming in the fluidics due to evaporation of the elution fluid.

Step 1 – From the Main Menu select Maintenance>Shut Down.

Step 2 – Follow the menu prompt: Remove Foam Can. Select Continue.

Step 3 – Follow the menu prompt: Place Maintenance Tip into Tip Port. Select Continue.

Step 4 – Follow the menu prompt: Insert Storage Fluid Line into Can Port. To do so, remove the orange cap from

the Storage Fluid Adapter and insert the tube fitting into the Canister Interface Port by pressing it firmly in place

(the fitting will only go in about 1/8th - inch). Select Continue. The fluid will rinse through the instrument to the

permeate.

Step 5 – Follow the menu prompt: Power Off Unit or Restart. Leave the Maintenance Tip and Storage Fluid

Adapter in place for the entire time that the instrument is not in use. For long term storage it is recommended

that the orange rubber port cap that arrives with the instrument be used in place of the storage fluid. Instructions

for preparing the instrument for transport or shipment are provided below in Section 6.5.

6.4 PRIMING THE ELUTION FLUID

A manual elution fluid prime is required when installing a new Elution Fluid Canister. Its function is to purge the foam line

of air or any fluid that may have lost carbonation.

Step 1 – From the Main Menu select Maintenance>Prime.

Step 2 – Follow the menu prompt: Place Maintenance Tip into Tip Port. Select Continue.

Step 3 – Follow the menu prompt: Place Foam Can (Elution Fluid Canister) Into Position. Select Continue. Fluid

from the Canister will rinse through to permeate. The Run Protocol menu will be displayed upon completion so

use can be resumed.

6.5 PREPARING THE INSTRUMENT FOR TRANSPORT OR SHIPMENT

It is important to prepare the instrument before transporting or shipping the instrument, or for returning the instrument

for repair or service. The Shut Down procedure should first be performed to decontaminate the instrument. A modified

second Shut Down procedure is then performed to flush the Storage Fluid from the system.

Step 1 – From the Main Menu select Maintenance>Shut Down.

Step 2 – Follow the menu prompt: Remove Foam Can. Select Continue.

Step 3 – Follow the menu prompt: Place Maintenance Tip into Tip Port. Select Continue.

Step 4 – Follow the menu prompt: Insert Storage Fluid Line into Can Port. To do so, remove the orange cap from

the Storage Fluid Adapter and insert the tube fitting into the Canister Interface Port by pressing it firmly in place

(the fitting will only go in about 1/8th - inch). Select Continue. The fluid will rinse through the instrument to the

permeate.

Step 5 – At the menu prompt: Power Off Unit or Restart. Leave the Maintenance Tip and Storage Fluid Adapter

in place and Power Off the unit.

Step 6 – Allow the instrument to sit for 30 minutes to ensure complete decontamination of the fluidics.

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