The Touch Tear MicroAssay SystemÔ

M9 6-Channel Reflectance Photometer

Instruction Manual

Table of Contents

1.0 Overview

2.0 System Assembly

3.0 Getting Started

3.1 Status Lights
3.2 System Startup

4.0 MAIN Menu

5.0 SETUP Menu

5.1 PRACTICE
5.2 DOCTOR
5.3 TECHNICIAN
5.4 CLOCK
5.5 OUTPUT
5.6 Code Update

6.0 OPTIONS Menu

6.1 Print DBASE
6.2 Print Audit Trail
6.3 Clear Audit Trail

7.0 ANALYZE Menus

7.1 Lactoferrin
7.2 IgE
7.3 Tear Clearance

8.0 Printer


1.0 Overview

The hardware for the Touch Tear MicroAssay SystemÔ consists of the M9 reflectance photometer, a printer, associated cables, a calibration card, and this instruction manual.


2.0 System Assembly

2.1 Power Cord

The Power Cord is used to connect the M9 to a source of electricity. The Power Cord is shipped in the same box as the M9. Insert the female end of the Power Cord into the back of the M9. This is a snug fit and reasonable force is required for proper connection. Plug the other end into a surge protector that is connected to a wall socket. The M9 power-supply is designed to be self-adjusting and will automatically accommodate any power source providing 85-264 volts (AC) at 50-60 hertz.

2.2 Printer Cable

The Printer Cable is used to connect the M9 to the printer so that test results may be printed. The Printer Cable is shipped in the same box as the printer. Connect the small end of the Printer Cable into the CENTER serial port on the back of the M9. Note that the cable-end is keyed so that it only fits in a certain way. The other end of the cable is also keyed and fits into the wide slot in the back of the printer. Secure both ends of the cable by tightening the connecting screws to prevent accidental disconnection. For specific instructions on how to Setup and Operate the Printer, see the section titled Printer in this manual.

3.0 Getting Started

3.1 Status Lights

The Status Lights allow a quick check on the operational capability of the M9. The Status Lights are located on the upper face of the M9, between the LCD and the Test Card slot.

POWER n Indicates that the switch is on, and the system is supplied with electricity.
NVMS n Constant: Non-Volatile Memory Systems and user database are OK.
  n Flashing: Non-Volatile Memory Systems are OK, but the database (Practice name, Doctors, etc.) does not have all of the required entries.
  n Not Lit: Non-Volatile Memory System error. Contact Field Service immediately!
CALIBRATED n Lighted continuously after a successful calibration.
READY n Indicates M9 is standing by for analysis.
ACTIVE n Flashes when testing is in progress.
FAULT n Flashes to indicate system error, or the interruption of a test cycle.

3.2 System Startup

Turn on the power by using the On/Off switch on the back-left side of the M9 unit. The screen will be blank for a few seconds while the M9 performs self-diagnostic tests as it powers up. The screen will then display:

Tests in progress
Memory... Passed

Then:

Tests in progress
Printer... Connected

Or (if a printer is not attached to the M9 printer port):

Tests in progress
Printer... Disconnected

The printer must be connected to the M9 at power-up, or it will not function.

After successful power-up the screen will display:

TSI 9E/2 Tear uAssay System V2.49
*** Press Key To Continue ***

Touch any key and the screen will display:

Insert Calibration Card
...................===> ===> ===>

With the label on the Calibration Card facing upwards, insert the card, notched-edge-first, into the card slot on the front-right of the M9 unit. The screen will display:

Checking Calibration. Please wait...
.

NOTE: If the calibration card is pulled out prematurely, or if the calibration fails, the screen will display:

Calibration Failed! Calibrate Again?
............[NO] .YES .......64.9

Attempt to recalibrate the machine. If unsuccessful, contact Touch Scientific!

Upon successful calibration the screen will display:

Successful Calibration
*** Press Key To Continue ***

Touch any key and the screen will display the MAIN Menu:

Main Menu Tuesday, 19 February 2008 12:50:31 PM
[Analyze]
. Setup. Options..........

4.0 MAIN MENU

The MAIN Menu is the starting place to access all of the M9 functions.

To make a selection, move the brackets among the items on the lower line of the display screen by using the {¬ }{® } keys. Touch the {ENTER} key.


5.0 SETUP Menu

SETUP is used to enter information into the user database.

Accessing the SETUP Menu

Using the {¬}{®} keys to position the brackets in the MAIN Menu, select [SETUP].

Touch the {ENTER} key. The screen will display:

Select a feature to SETUP:
[Practice] Doctor
. Tech. Output. More

As before, select a feature by moving the brackets to the desired item, then touch the {ENTER} key.

5.1 PRACTICE Menu

This feature allows the recording of information about the medical Practice. Only one Practice can be entered. A total of 40 spaces is available per line. The user is prompted for information about the Practice in the following order:

Name (Line 1,2,3) ® Address (Line 1,2,3) ® Phone #

NOTE: If no Practice information is present the NVMS light will blink signifying that the user database does not contain sufficient information to permit access to the ANALYSIS mode.

Adding or changing the Practice

Using the {¬}{®} keys to position the brackets in the MAIN Menu, select [SETUP].

Touch the {ENTER} key. Likewise, in the SETUP Menu, select [PRACTICE].

Touch the {ENTER} key. The screen will display:

Edit Name (line 1) (PRACTICE)

There are three display screens available for entering the Practice Name. Touching the {ENTER} key will activate the subsequent Name screens. Touching the {ENTER} key after the third screen for the Practice Name, the screen will display:

Edit Address (line 1) (PRACTICE)
_

There are three display screens available for entering the Practice Address. Touching the {ENTER} key will activate the subsequent Address screens. Touching the {ENTER} key after the third screen for the Practice Address, the screen will display:

Edit Phone
__

There is one field of forty (40) characters for the phone number. After entering the phone number, touch the {ENTER} key. This will return the M9 to the MAIN Menu.

5.2 DOCTOR Menu

A total of 20 doctors' names can be entered into the system database.

Entering a Doctor's name

Using the {¬}{®} keys to position the brackets in the MAIN Menu, select [SETUP].

Touch the {ENTER} key. Likewise, in the SETUP Menu, select [DOCTOR].

Touch the {ENTER} key. If the Doctor database is empty the screen will display:

Doctor list is empty, type doctor name:
_

Enter the name, and then touch the {ENTER} key. The screen will return to the SETUP menu.

Adding a Doctor's name

Using the {¬}{®} keys to position the brackets in the MAIN Menu, select [SETUP].

Touch the {ENTER} key. Likewise, in the SETUP Menu, select [DOCTOR].

Touch the {ENTER} key. The screen will display:

INSert, DELete, ESCape 01 of 01
Dr. Who
.......................

Touch the {INS} key to add a doctor to the database. Type the doctor's name and then touch the {ENTER} key. The screen will return to the SETUP menu after briefly displaying:

INSert, DELete, ESCape 01 of 01
Doctor database updated

Deleting an existing entry

Using the {¬}{®} keys to position the brackets in the MAIN Menu, select [SETUP].

Touch the {ENTER} key. Likewise, in the SETUP Menu, select [DOCTOR].

Touch the {ENTER} key. If there are doctor names in the database, the screen will display:

INSert, DELete, ESCape 01 of 01
Dr. Who
......................

Using the {¬}{®} keys, toggle through the database until the name to be deleted is displayed on the screen. Touch the {DEL} key. The screen will display:

Delete this entry? (yes/no)
Dr. Who
...................

Touch the {YES} key. The screen will return to the SETUP menu after briefly displaying:

Entry erased
Dr. Who

5.3 TECHNICIAN Menu

This feature allows installation of 20 technician names into the database. This is optional but should be used, especially if there is more than one technician performing analyses. Knowing who performed each assay is important for good Quality Control, and is an essential part of Good Laboratory Practice. All of the instructions that pertain to the maintenance of the DOCTOR database (Section 5.2) also apply to the TECH database.

5.4 CLOCK Menu

The Clock feature is for setting the day and time functions in the M9 system. This is important for ensuring a correct Audit Trail. Once set, it should not need changing since the system retains the correct date and time settings, even when the machine is turned off.

Setting the CLOCK

Using the {¬}{®} keys to position the brackets in the MAIN Menu, select [SETUP].

Touch the {ENTER} key. In the SETUP Menu, select [More], then [Clock].

Touch the {ENTER} key. The screen will display:

Esc finishes, arrows move, Enter Selects
12:50 02/19/2008

Time is to be set in a military mode, but is displayed in AM/PM mode. Use the {¬}{®} keys to move the cursor to various areas of the time and date settings. When the cursor is on the field to be set, touch {ENTER}. Make the desired changes to that field by using the {¬}{®} keys, and then touch the {ENTER} key again. Repeat the previous steps to edit the necessary fields. When all the fields have been edited correctly, touch the {ESC} key. This will update the changes to the clock, and then return to the SETUP menu screen.

NOTE: This unit is designed for international use. Since some locations do not change time for Daylight Savings Time (DST) the machine does not automatically adjust. If you are in an area that observes DST, you will have to reset the clock in the Spring and Fall.

5.5 OUTPUT Menu

This feature allows the user to change the data output from the printer port (center), to the serial port (closest to the power cord). It also allows for the change in data configuration from the normal (short) printout, to a much more detailed (long) format. These changes should only be made under supervised situations.

Selecting or Changing Output Ports

Using the {¬}{®} keys to position the brackets in the MAIN Menu, select [SETUP].

Main Menu Tuesday, 19 February 2008 12:50:31 PM
Analyze [Setup] Options

Touch the {ENTER} key. Similarly, in the Setup Menu, select [OUTPUT].

Select a feature to SETUP:
Practice Doctor Tech [Output] More

Touch the {ENTER} key. The screen will display:

Report Output and Type
[Printer] Serial Long Form Short Form

Use the {®} key to select the desired change and touch the {ENTER} key. The screen will return to the SETUP menu after briefly displaying:

Report Output and Type
Reports now sent to serial port

Or, if a change in format was selected, after briefly displaying:

Report Output and Type
Output will use the long format

NOTE: The printer port has a male connector and the serial port has a female connector in the back of the M9. The cable that comes with the M9 printer is set up to use the printer port. Using the serial port instead of the printer port will require a different connector cable.

5.6 Code Update

This feature allows the operating software to be upgraded by utilizing the internal modem.

Preparing the M9 for software download

Using the {¬}{®} keys to position the brackets in the MAIN Menu, select [SETUP].

Main Menu Tuesday, 19 February 2008 12:50:31 PM
Analyze [Setup] Options

Touch the {ENTER} key. In the Setup Menu, select [More].

Select a feature to SETUP:
Practice Doctor Tech Output [More]

Touch the {ENTER} key. Select [Code Update].

Select a feature to SETUP:
Clock [Code Update]

Touch the {ENTER} key. The screen will display:

Waiting for phone to ring...

Call Touch Scientific to request a Code Update. TSI will need to know the phone number for the intended non-digital phone line to be called (a FAX line is ideal for this purpose). Connect a phone line from the modem-port on the M9 to the non-digital phone jack. When the modem is contacted by TSI, the following screen will temporarily be dispayed:

Spinny indicates transmission ->

As the new code is being downloaded, the screen will display changing characters similar to the following:

Rxr:x01 Txr:x00 CRC:x1234
L:x002b C:x01 01:x0002 02:xa120 -> ¥

The downloading process will require 10 to 20 minutes. Do not disconnect the phone line or interrupt the power supply. When complete, the M9 will reboot using the new code.


6.0 OPTIONS Menu

This menu allows the M9 to print the database, print the audit trail, or clear the audit trail.

6.1 Printing the Database

Using the {¬}{®} keys to position the brackets in the MAIN Menu, select [OPTIONS].

Main Menu Tuesday, 19 February 2008 12:50:31 PM
Analyze Setup [Options]

Touch the {ENTER} key. The screen will display:

Select an OPTION:
[DBase-Print] Audit-Print Audit-Clear

Select [DBASE-Print] and then touch the {ENTER} key. The Practice Name, followed by a list of the Doctors and then Technicians, will be printed.

6.2 Printing the Audit Trail

The Audit Trail allows the user to maintain a serial record of M9 activities. This record includes dates and times for when assays were performed, patient identification information, attending physician, and technician ID. The Audit Trail should be printed on a periodic basis, such as weekly, and maintained as a permanent record. Once the printout is obtained, the Audit Trail should be cleared to allow for new data to be stored. The Audit Trail printout is intentionally a separate issue from clearing the Audit Trail memory. Therefore, if a printout is incomplete due to printer error, no data will be cleared until the M9 is instructed to do so.

Using the {¬}{®} keys to position the brackets in the MAIN Menu, select [OPTIONS].

Main Menu Tuesday, 19 February 2008 12:50:31 PM
Analyze Setup [Options]

Touch the {ENTER} key. The screen will display:

Select an OPTION:
DBase-Print [Audit-Print] Audit-Clear

Using the {®} key, select [AUDIT-PRINT]. Touch the {ENTER} key to display:

Printing...

A serial record of M9 activities will be printed. This record includes dates and times for when assays were performed, patient ID information, attending physician, and technician ID.

6.3 Clearing the Audit Trail

Before the Audit Trail is cleared, a printout should be thoroughly reviewed.

Using the {¬}{®} keys to position the brackets in the MAIN Menu, select [OPTIONS].

Main Menu Tuesday, 19 February 2008 12:50:31 PM
Analyze Setup [Options]

Touch the {ENTER} key. The screen will display:

Select an OPTION:
DBase-Print Audit-Print [Audit-Clear]

Using the {®} key, select [AUDIT-CLEAR], touch the {ENTER} key to display:

Erase all patient records?
[Yes] No

In the event this screen has been accessed by accident, touch the {®} key to move the brackets to [NO]. Touch the {ENTER} key to return to the OPTION Menu.

To clear the Audit Trail, position the brackets around [Yes] and touch the {ENTER} key. The screen will temporarily display:


Erasing Records...

The screen will then return to the OPTION menu.


7.0 ANALYZE Menu

The ANALYZE section is a guide through the keystrokes and screens which occur during sample analysis. The system must be SETUP with the PRACTICE and DOCTOR data before any analysis can be conducted.

Before initiating an assay, check the M9's status as indicated by the Status Lights. The Ready light should be lit to show that the system is ready for an assay. If the Active light is lit, investigate the cause before proceeding. If it is flashing, testing may already be in progress.

*** IMPORTANT ***
When performing an assay, carefully follow the instructions found in the package insert.

Using the ANALYZE Menu

Using the {¬}{®} keys to position the brackets in the MAIN Menu, select [ANALYZE].

Main Menu Tuesday, 19 February 2008 12:50:31 PM
[Analyze] Setup Options

Touch the {ENTER} key. The screen will display:

Choose Doctor using <- and -> 01 of 01
Dr. Who

Using the {¬}{®} keys, scroll through the doctor queue in the database until the doctor requesting the assay is located, then touch the {ENTER} key. If there are TECH's in the database, the system will prompt for a technician's ID:

Choose Tech using <- and -> 01 of 01
Tech One

Select the name of the person performing the assay in the same manner as the name of the doctor was located. Touch the {ENTER} key. The screen will display:

Select a test:
[LFN] IgE GRM TCR LDH Chl HSV Adv

7.1 Lactoferrin [LFN]:

Using the {¬}{®} keys, place the brackets around LFN, then touch the {ENTER} key. The screen will display:

Enter Patient Name
_

Enter the patient's name. Touch the {ENTER} key. The screen will display:

Enter Patient I.D.
_

This field is optional. Touching the {ENTER} key will leave the field blank and the program will proceed to the next display screen:

Enter the kit Lot Number
_

Including the kit lot number is a good Quality Control procedure. Type the lot number of the lactoferrin kit to be used. Touching the {ENTER} key will proceed to the next display screen:

Select card type:
[4 Channel] 2 Channel

Select which type of card format is to be used. Selecting the [4 Channel] card will display the following screen:

Select whether a Standard is to be run
[No] Low Std High Std

Select whether a Low or High Standard is to be run on this card. Including a standard is a good Quality Control procedure, and should be run daily as per CLIA guidelines. Touching the {ENTER} key will proceed to the first analysis display screen:

STEP 1: Add tear samples (and Standard).
STEP 2: Add Control, and then TOUCH YES.

Using a microcapillary tube, transfer 2 ml of the diluted tear sample from its micro-vial to the membrane on the card labeled "Patient Sample." Transfer 2 ml of the kit Control solution to the "Control" membrane on the test card. Touch the {YES} key. The screen will display:

Step 3: Add Conjugate to each membrane.
After absorption, TOUCH YES.

Add one drop of the CONJUGATE solution to each membrane. Wait for full absorption. Touch the {YES} key. The screen will then display:

Please Wait...
Time Remaining: 59

The readout in the bottom right-hand corner of the screen is the display for a count-down timer. The numbers represent the seconds remaining for the Conjugate incubation. This incubation timer ensures that the Conjugate solution has a standard amount of reaction time. Strict adherence to timed intervals is important if accurate results are to be achieved. At the end of the CONJUGATE incubation period the screen will automatically display:

STEP 4: Add three drops of WASH solution
to each membrane. TOUCH YES.

Be prepared to add three drops of Wash solution to each membrane. Alternate drops between the membranes allowing time for the fluid to be completely absorbed prior to adding subsequent drops. Touch the {YES} key. The screen will display:

STEP 5: Add TMB Substrate solution to
each membrane. Insert Card ===> .
===> ===> ===>

Add one drop of TMB Substrate solution to each membrane on the test card and wait for absorption. Insert the card into the slot in the M9. The screen will display:

Reading in progress. Please wait...
Time remaining: 4:14

The Active light will begin flashing. As with the Conjugate incubation step, a count-down timer is displayed in the bottom right-hand corner of the screen. This analysis will last for 4.25 minutes. At the end of this reading step, the screen will display:

printing...

When the results are finished printing, the screen will display the results:

LFN Control:

If the card is removed from the M9 during the reading step, the screen will display:

ANALYSIS ABORTED!!!
Press any key to continue

Touching any key returns the M9 to the MAIN Menu.

 

7.2 IgE:

Using the {¬}{®} keys to position the brackets in the MAIN Menu, select [ANALYZE].

Using the {¬}{®} keys, scroll through the doctor queue in the database until the doctor requesting the assay is located, then touch the {ENTER} key.

If there are TECH's in the database, the system will prompt for a technician's ID. Select the name of the person performing the assay in the same manner as the name of the doctor was located, then touch the {ENTER} key.

Place the brackets around IgE, then touch the {ENTER} key. The screen will display:

Enter Patient Name
_

Enter the patient's name. Touch the {ENTER} key. The screen will display:

Enter Patient I.D.
_

This field is optional. Touching the {ENTER} key will leave the field blank and the program will proceed to the next display screen:

Enter the kit Lot Number
_

Including the kit lot number is a good Quality Control procedure. Type the lot number of the IgE kit to be used. Touching the {ENTER} key will proceed to the next display screen:

Select card type:
[4 Channel] 2 Channel

Select which type of card format is to be used. Selecting the [4 Channel] card will display the following screen:

Select whether a Standard is to be run
[No] Low Std High Std

Select whether a Low or High Standard is to be run on this card. Including a standard is a good Quality Control procedure, and should be run daily as per CLIA guidelines. Touching the {ENTER} key will proceed to the first analysis display screen:

STEP 1: Add tear samples (and Standard).
STEP 2: Add Control, and then TOUCH YES.

Using a microcapillary tube, transfer ½ ml of the tear samples to the membranes on the card labeled "Patient Sample." Transfer ½ ml of the kit Control solution to the "Control" membrane on the test card. Do Not touch the {YES} key yet. Be aware that M9 menu screen will go directly to the Conjugate incubation step from the step requesting the Samples and Control. It completely skips the step requesting the conjugate to be added. Therefore, when the M9 instructs you to add the samples and control, do not touch the "Yes" key before adding a drop of conjugate to each membrane. Wait for absorption of the conjugate, and then touch the "Yes" key on the M9. If you touch "Yes" before adding the conjugate, simply ignore the internal M9 timer that will have been activated, and manually time the 60-second incubation step using an available clock or wristwatch. Proceed as normal with the remainder of the assay. After adding a drop of conjugate to each membrane, touch {Yes} and the screen will display:

Please Wait...
Time Remaining: 59

The readout in the bottom right-hand corner of the screen is the display for a count-down timer. The numbers represent the seconds remaining for the conjugate incubation. This incubation timer ensures that the conjugate incubation has a standard amount of reaction time. Strict adherence to timed intervals is important if accurate results are to be achieved. At the end of the conjugate incubation period the screen will automatically display:

STEP 3: Add three drops of WASH solution
to each membrane. TOUCH YES.

Be prepared to add three drops of Wash solution to each membrane. Alternate drops between the membranes allowing time for the fluid to be completely absorbed prior to adding subsequent drops. Touch the {YES} key. The screen will display:

STEP 4: Add TMB Substrate solution to
each membrane. Insert Card ===>

Add one drop of TMB Substrate solution to each membrane on the test card and wait for absorption. Insert the card into the slot in the M9. The screen will display:

Reading in progress. Please wait...
Time remaining: 4:14

The Active light will begin flashing. As with the Conjugate incubation step, a count-down timer is displayed in the bottom right-hand corner of the screen. This analysis will last for 4.25 minutes. At the end of this reading step, the screen will display:

printing...

When the results are finished printing, the screen will display the results:

IgE Control: Valid

If the card is removed from the M9 during the reading step, the screen will display:

ANALYSIS ABORTED!!!
Press any key to continue

Touching any key returns the M9 to the MAIN Menu.

7.3 Tear Clearance Assay

Manual Timing Method

The manual timing method may be started without the aid of the M9 instrument. Obtain the following items:

Unused Tear Clearance card
Sodium Fluorescein (2%)
Microcapillary tubes (5 m l and ½ m l)
Timer and notepad

On a notepad, record the following data for future use:

Patient name and Patient ID
Attending physician
Operating technician
Lot number of the TCR kit
Samples 1 & 2 elapsed sampling times (start and finish)

  1. Instill 5 µl of fluorescein sodium (2%) into the lower conjunctival sac.
  2. Immediately start a timing device. Write the patient name and ID on a TCR test card.
  3. At 5-6 minutes post-instillation, collect ½ m l of tears using a new capillary tube (as per the recommended "Specimen Collection" procedure). Ensure that the elapsed sampling times are accurately recorded (start and finish).
  4. Transfer this tear sample to the membrane labeled 'Sample 1' on the test card.
  5. At 15-18 minutes post-instillation, collect ½ m l of tears using a new capillary tube (as per the recommended "Specimen Collection" procedure). Ensure that the elapsed sampling times are accurately recorded (start and finish).
  6. Transfer this tear sample to the membrane labeled 'Sample 2' on the test card.

Analyzing the Manual Test Card:

Using the {¬}{®} keys to position the brackets in the MAIN Menu, select [ANALYZE].

Using the {¬}{®} keys, scroll through the doctor queue in the database until the doctor requesting the assay is located, then touch the {ENTER} key.

If there are TECH's in the database, the system will prompt for a technician's ID. Select the name of the person performing the assay in the same manner as the name of the doctor was located, then touch the {ENTER} key.

Place the brackets around TCR, then touch the {ENTER} key. The screen will display:

Enter Patient Name
_

Enter the patient's name from the keyboard. Touch the {ENTER} key to display:

Enter Patient I.D.
_

This field is optional. Touching the {ENTER} key will leave the field blank and the program will proceed to the next display screen:

Enter the kit Lot Number
_

Including the kit lot number is a good Quality Control procedure. Type the lot number of the TCR kit to be used. Touching the {ENTER} key will activate the initialization step:

*** Initialization Step ***
Insert a TCR Test Card -> -> ->

Insert an unused Tear Clearance card into the M9. The screen will display:

Successful Initialization!
Remove the Test Card -> -> ->

Removing the card from the M9e will prompt the following display:

Select the timing method to be used:
[Automatic] Manual

Position the brackets around [Manual]. Touching {ENTER} will display:

Instill 5 ul of 2% Fluorescein Sodium
Immediately activate a timer!

Touch {ENTER}. The screen will display:

Record ELAPSED time interval (min:sec)
when collecting tear samples!

Touch {ENTER}. The screen will display:

Transfer Sample 1 to the TCR Test Card

Touch {ENTER}. The screen will display:

Record the time collection was begun:
_

Enter the elapsed time (min:sec) from the instillation of NaFl to the time that tear sample 1 was begun to be taken. Touch {ENTER}. The screen will display:

Record the time collection is completed:
_

Enter the elapsed time (min:sec) from the instillation of NaFl to the time that tear sample 1 was finished being taken. Touch {ENTER}. The screen will display:

You Entered: 5:12 to 5:23
[YES] NO

Touch {ENTER} when the data is correct. The screen will display:

Transfer Sample 2 to the TCR Test Card

Touch {ENTER}. The screen will display:

Record the time collection was begun:
_

Record the elapsed time (min:sec) from the instillation of NaFl to the time that tear sample 2 was begun to be taken. Touch {ENTER}. The screen will display:

Record the time collection is completed:
_

Record the elapsed time (min:sec) from the instillation of NaFl to the time that tear sample 2 was finished being taken. Touch {ENTER}. The screen will display:

You Entered: 15:05 to 15:19
[YES] NO

Touch {ENTER} when the data is correct. The screen will display:

Re-insert the Test Card -> -> ->

Insert the patient test card. The algorithm calculates the Tear Clearance Rate (TCR):

Tear Clearance Rate:
11.3% per minute

If ‘Invalid’ is displayed on the screen, evaluate the protocol for possible errors. See the Tear Clearance package insert for specific details.


8.0 Printer

The printer which comes with the M9 is an impact dot-matrix printer with a serial interface. This compact, light-weight printer is provided with the various functions needed to meet the data access requirements of the M9 system.

Accessories

Check all of the printer accessories against the following list. If anything is missing, contact the Touch Scientific customer service department.

o Roll of paper
o Printer ribbon cassette (installed)
o Printer serial cable

Basic Specifications

Printing Method Serial Dot Matrix
Printing Speed 74 LPM with 40 column, 235 LPM with 5 column
Character 7 x 5 (Dots)
Column Capacity 40 column
Character Size 2.75 mm (H) x 1.25 mm (W)
Line Spacing 5.5 mm
Line Feed Speed 6.2 lines / second approx.
Paper Width 69 ± 1 mm, External diameter 80 mm
Ink Ribbon Cassette In red and black, Width 13 mm
Voltage 120 V ± 10% 50/60 Hz (for UL, CSA)
  230 V ± 10% 50/60 Hz (for EP)
Power 35 W max.
Weight 2.3 Kg (5.1 lbs) Approx.
Dimensions 240 mm x 231.5 mm x 111.5 mm (WxDxH)
  9.4" x 9.1" x 4.4" (WxDxH)
Interface Serial Interface RS-232C
Operating Temp 50C to 350C (410F to 950F)
Storage Temperature -250C to 600C (-130F to 1400F)

Description

Power plug Insert this plug into a wall socket of the prescribed voltage.
Power switch As the power switch is turned "ON" the printer starts and the print-head returns to the left-end "home" position.
Power lamp This light turns on/off with the power switch.
SEL lamp This lamp lights-up when the printer is in a Select (On-Line) mode, and is off when the printer is in a DeSelect (Off-Line) mode.
ALM lamp This Alarm lamp is activated when the printer operation is out of the normal function mode. When this happens, printing and Line Feed operation is suspended. To release from an Alarm state, push the SEL button or turn "OFF" the power and turn "ON" again.
LF key Use the LF button for line feeding when the printer is in a DeSelect mode
SEL key Use the SEL button to place the printer in a Select (On-Line) mode.
Printer cover Set the cover correctly in place so that dust and noise can be minimized.
Interface This is for connection with the M9. Ensure that both the M9 and the printer are "OFF" before connecting the cable.

Operation

Loading the Paper

  1. Remove the paper cover
  2. Cut the paper in a right-angle to its longitudinal center-line.
  3. Insert the paper into the inlet at the back of the printer.
  4. Turn "On" the power switch and feed the paper by touching the LF button.
  5. Feed the paper through the slot in the paper cover, and then replace the cover.

Installing the Ribbon Cassette

  1. Disconnect the power source beforehand.
  2. If the printer has been operating for many hours, the printer head may be hot. Allow to cool.
  3. Remove the printer cover. Carefully note how the old printer ribbon cassette is setup and how it is threaded through the print-head apparatus.
  4. Remove the old cassette, and replace it with a new cassette in the same configuration.
  5. Check that the ribbon is not sagging or twisted.
  6. Feed the paper through the slot in the paper cover, and then replace the cover.

Testing the Printer

The printer has a self-printing test-pattern in order to check the printing function. Take the following steps to test your printer:

  1. Ensure that the paper and ribbon are properly installed.
  2. Turn "OFF" the power switch.
  3. Turn "ON" the power switch while keeping the LF button pressed-down, then release the LF button. The print test-pattern should start.
  4. To stop the printing, turn "OFF" the power switch. After 28 lines are printed, the printing will stop automatically.

Running the Printer

Turn on the power switch and touch the SEL button to bring the printer on-line.

Precautions

  1. Never operate the printer without loading paper and installing the Ink Ribbon. Any printing without paper and an Ink Ribbon may cause damage to the printer head.
  2. Replace the ink ribbon before it is worn out.
  3. Be careful not to drop any foreign matter such as paper clips, pins, etc. into the printer.
  4. Do not place anything on the printer's cooling vents.
  5. Always place the printer on a stable, horizontal surface.
  6. Organic solvents (alcohol, thinner, benzene, etc.) should Not be used in the cleaning of the printer.
  7. Make sure that the power is turned off when removing foreign matter which has dropped into the printer or when replacing the ink ribbon.

Maintenance

The mechanical part of the printer must be free from dirt and dust. Remove the printer cover periodically and clean the printer mechanism with a soft brush.