BioVue System Heat Block-32 Users Manual Oct 2013

THIS PAGE INTENTIONALLY LEFT BLANK

Ortho BioVue® System Heat Block-32 EN

User’s Manual

41130

Ortho-Clinical Diagnostics Johnson & Johnson 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4DP United Kingdom

5mm size (minimum)

XXXX

0123

2013-10-07

Ortho BioVue System Heat Block-32

EN-1

 WARNING: CAREFULLY READ AND FOLLOW THE INSTRUCTIONS PROVIDED IN THIS MANUAL BEFORE OPERATING THE INSTRUMENT

EN Customer - For Future Reference: In the box below, please transcribe the serial number as it appears on the rear plate of the incubator.

Ortho BioVue System Heat Block-32 SN:

Manufacturer’s Name:

Ortho-Clinical Diagnostics, Inc.

Manufacturer’s Address:

Raritan, New Jersey 08869

Product Name:

Ortho BioVue System Heat Block-32

Proprietary Notice No part of this manual may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying and recording, for any purpose without the express written permission of Ortho-Clinical Diagnostics, Inc.

BioVue is a registered trademark of Ortho-Clinical Diagnostics, Inc.

Copyright © by Ortho-Clinical Diagnostics, Inc. 2002 Raritan NJ 08869 All rights reserved.

EN-2

Ortho BioVue System Heat Block-32

2013-10-07

Table of Contents Topic Page Section 1 - Description... EN-5 Intended Use ... EN-5 Overview... EN-5 Physical Description... EN-6 Section 2 - Specifications... EN-7 Section 3 - Installation ... EN-8 Unpacking Procedure... EN-8 Installation Procedure... EN-8 Site Specifications... EN-9 Environmental Requirements... EN-9 Electrical Requirements... EN-10 Section 4 - Quality Assurance... EN-11 General... EN-11 Thermometer Verification... EN-11 Timer Verification ... EN-11 Section 5 - Operation ... EN-12 Section 6 - Temperature Selection/Correction Procedure... EN-14 Temperature Selection Procedure ... EN-14 Temperature Correction Procedure... EN-14 Section 7 - Maintenance ... EN-16 Cleaning... EN-16 Replacing Fuses... EN-16 Thermometer Verification... EN-16 Timer Verification ... EN-16 Section 8 - Troubleshooting Guide... EN-17 Section 9 - Instrument Disinfection... EN-18 Disinfection Procedure... EN-18 Disinfection Certificate... EN-19 Section 10 - Environmental Directives ... EN-20 Disposal... EN-20

Chinese Environmental Regulations on Hazardous Substances (China RoHS)... EN-20

Section 11 - Warranty... EN-21 Warranty Time Period... EN-21 Warranty Repair Coverage... EN-21 Limitations ... EN-21 Section 12 - Spare Parts List... EN-22 Revision History ... EN-23 Key to Symbols ... EN-25

2013-10-07

Ortho BioVue System Heat Block-32

EN-3

EN

EN

THIS PAGE INTENTIONALLY LEFT BLANK

EN-4

BioVue System Heat Block-32

2013-10-07

Section 1 - Description Intended Use The Ortho BioVue® System Heat Block-32 is intended to be used to incubate Ortho BioVue® System Cassettes that require incubation. Overview The Ortho BioVue System Heat Block-32 has two thermally insulated independent blocks. Each block has a metacrilate lid that permits loading one block while the other is incubating. The special shape of the heater ensures that the reactive area of the cassettes will be at the right temperature. Each block is able to hold sixteen cassettes. A microprocessing system provides temperature control and permits selection of an internal temperature range of 36°C to 39.5°C in 0.5°C increments. Incubation times from 1 to 99 minutes can be selected for each block. The default time is 10 minutes. Incubation temperature and timed countdown are displayed on the front of the incubator. The system is protected against overheating and includes a glass thermometer for comparison with the digital display. When incubation is finished, an alarm sounds and the display blinks.

2013-10-07

Ortho BioVue System Heat Block-32

EN-5

EN

Section 1 - Description, continued Physical Description

EN

Display Description LEFT BLOCK

RIGHT BLOCK

FUNCTION

D1 D3 Shows the incubation temperature. User messages: “H i.t” “Lo.t” D2 D4

Shows the timed countdown. User messages: “En.d”

Keyboard Description

LEFT BLOCK

K1

K2

Increase the incubation time.

K3

K4

Decrease the incubation time.

K5 K6

Start the timed countdown. Stop counting. Reset to the last incubation time when the countdown is finished.

EN-6

RIGHT BLOCK

Ortho BioVue System Heat Block-32

FUNCTION

2013-10-07

Section 2 - Specifications Voltage:

95-140 / 180-240 V~

Power Consumption:

200 W

Fuses (from Switched Fused Chassis Plug):

2 x (F 1A L) 5 x 20 mm

Frequency:

50 – 60 Hz

EN

Incubation Temperature: 36°C to 39.5°C in 0.5°C increments (default temperature, 37°C) Incubation Time: 1 to 99 minutes (default time, 10 minutes)

2013-10-07

Capacity:

32 cassettes

Dimensions:

 idth: 27 cm W Length: 42 cm Height: 11 cm

Weight:

8.0 kg

Ortho BioVue System Heat Block-32

EN-7

Section 3 - Installation Unpacking Procedure The Ortho BioVue System Heat Block-32 is packaged in one carton which includes: • Power cord • User’s manual

EN

1. Visually inspect the carton for damage before it is opened. Report any damage immediately to the freight carrier. 2. To place the instrument, select a location that is flat, level, vibration free, away from direct sunlight, and free from dust, solvents and acid vapors. 3. Place the carton in an upright position and open it. 4. Lift the instrument out of the carton and place it in the selected location. 5. Visually inspect the instrument for loose, bent or broken parts.  Report any damage immediately by contacting the hotline number provided by your local Ortho-Clinical Diagnostics (OCD) company or distributor. 6. Compare the serial number on the rear panel of the instrument with the serial number in the packing slip and the quality control assurance sheet serial number.  Report any damage immediately by contacting the hotline number provided by your local Ortho-Clinical Diagnostics company or distributor. 7. Save packing materials for future use. Installation Procedure

• Be sure to place the Ortho BioVue System Heat Block-32 on a flat, level, vibrationfree surface away from direct sunlight, and free from dust, solvents and acid vapors. • Do not expose it to heat or cold (close to heating or air-conditioning systems). • Never subject it to violent shaking or any other shock or impact.

 Some units are equipped with a manual voltage selector located on the rear panel. Please check the rear panel of your unit to determine if it is equipped with a manual voltage selector. If so, please be careful to select the correct voltage in the voltage selector of the switched fuse chassis plug rear panel. Some units are equipped with an auto-switching power supply. These units will automatically detect the AC voltage level of the circuit it is attached to (95-140 V~ / 180-240 V~) and internally switch to the appropriate settings. If you do not know which setting to use, call the manufacturer for assistance.

EN-8

Ortho BioVue System Heat Block-32

2013-10-07

Section 3 - Installation, continued Installation Procedure, continued

1. Insert the appropriate end of the plug into the power receptacle in the rear of the instrument and the other end of the plug into a grounded wall outlet.

EN

2. Turn on the instrument using the switch located on the rear panel and determine that the display on the front panel is lit. 3. L et the Ortho BioVue System Heat Block-32 warm up for approximately 15 to 20 minutes before starting to work. This will allow it to reach and stabilize at the correct temperature. Site Specifications The Ortho BioVue System Heat Block-32 must rest upon a level bench or table large enough to accommodate the dimensions specified below and sturdy enough to support the weight of the incubator. Additional space should be provided adjacent to the incubator to permit easy operation and servicing.

Width= 27 cm Length= 42 cm Height=11 cm Weight= 8.0 kg

Environmental The Ortho BioVue System Heat Block-32 is designed to operate effectively within Requirements  the temperature and humidity ranges typically found in clinical laboratories. For effective operation, the temperature and relative humidity should be within the ranges indicated in the accompanying diagram. The legend below the diagram defines the “corners” indicated in the diagram.

Humidity %RH

Temperature

2013-10-07

Ortho BioVue System Heat Block-32

EN-9

Section 3 - Installation, continued

EN

Electrical The Ortho BioVue System Heat Block-32 must be plugged into a properly Requirements grounded receptacle. Receptacle grounding should comply with all applicable electrical safety codes. Proper grounding is essential to ensure proper operation and to minimize the likelihood of electrical damage to sensitive electronic circuits within the Ortho BioVue System Heat Block-32. If you are uncertain about your electrical service, please consult a qualified electrician.  ome units are equipped with a manual voltage selector located on the rear S panel. Please check the rear panel of your unit to determine if it is equipped with a manual voltage selector. If so, please be careful to select the correct voltage in the voltage selector of the switched fuse chassis plug rear panel. Some units are equipped with an auto-switching power supply. These units will automatically detect the AC voltage level of the circuit it is attached to (95-140 V~ / 180-240 V~) and internally switch to the appropriate settings. If you do not know which setting to use, call the manufacturer for assistance.

EN-10

Ortho BioVue System Heat Block-32

2013-10-07

Section 4 - Quality Assurance General Upon receipt of the Ortho BioVue System Heat Block-32, steps must be taken to ensure that no damage has occurred during transit to your site.  OTE: After installation, a quality control program must be followed through N the life of the incubator to provide assurance of accurate test results. On a regular basis, verify accuracy of the Ortho BioVue System Heat Block-32 for time and temperature according to your organization’s standard operating procedures. Thermometer Verification

Verify accuracy of the glass thermometer according to your organization’s standard operating procedures.  OTE: The incubator must not be used if the thermometer is out of N specification.

Timer Verification Verify accuracy of the timer according to your organization’s standard operating procedures. NOTE: The incubator must not be used if the timer is out of specification.

2013-10-07

Ortho BioVue System Heat Block-32

EN-11

EN

Section 5 - Operation  OTE: No special training is required to operate this instrument. All test N specimens and materials they contact should be handled using established good laboratory practices.

EN

1. Turn the instrument ON. NOTE: Ensure that the lid to each block is closed completely. 2. Wait until the temperature of the Ortho BioVue System Heat Block-32 is stabilized (15 to 20 minutes). Ensure the displayed temperature is correct by comparing the displayed temperature to the glass thermometer. If it is not correct, refer to Section 6 - Temperature Selection/Correction Procedure. If necessary, contact the hotline number provided by your local Ortho-Clinical Diagnostics company or distributor for assistance. 3. Open the lid. 4. Load the cassettes.  NOTE: Ensure that the lid to each block is closed completely at all times during incubation. 5. To select a desired incubation time other than the default (10 minutes), press the UP or DOWN key. 6. P  ress the START/STOP key to start incubation time. The instrument displays the remaining time continuously. When the incubation is completed, an alarm sounds and the display blinks “En.d.” To stop the alarm and reset the display, press the START/STOP key. 7. The following may occur during incubation: • If incubation temperature of the block is out of range (± 0.2°C) and the timer is not counting, timed countdown will be disabled. • If the incubation temperature of the block is greater than 1°C from the set point, the message “H i.t”

EN-12

will blink in the corresponding display.

Ortho BioVue System Heat Block-32

2013-10-07

Section 5 - Operation, continued • If the incubation temperature of the block is more than 1°C below the set point, the message “Lo.t”

EN

will blink in the corresponding display.

8. When incubation is finished, an alarm sounds and the display blinks the message “En.d.”

You can silence the instrument and reset the display by pressing the START/ STOP key.  AUTION: The alarm will NOT sound if the instrument goes out of the C specified temperature range during an incubation cycle.

2013-10-07

Ortho BioVue System Heat Block-32

EN-13

Section 6 - Temperature Selection/Correction Procedure

EN

Temperature Selection Procedure

NOTE: Refer to Section 1 - Description when reading this section. 1. Turn ON the instrument while depressing the left (K5) START/STOP key. 2. B  oth lower displays (D2 and D4) will show a time selection abbreviation “tS.EL.”

3. B  oth upper displays (D1 and D3) will show the default working temperature of 37°C.

4. To set different working temperatures in each of the blocks, use the Preset Time UP key to cycle through the selections. (The DOWN key is inactive in this mode.) Selection range is from 36°C to 39.5°C in 0.5°C increments. 5. O  nce the working temperature is selected in each block, depress the right START/STOP key (K6) to store the temperature in the EEPROM memory. 6. The incubator is ready to use after the temperature has reached the temperature selected. Temperature Correction Procedure

This procedure is used to adjust each displayed heating block temperature to the actual heating block temperature. 1. P  ut a thin, flexible temperature probe in a cassette reaction chamber filled with water. Place the cassette containing the probe into one of the incubator blocks. 2. Close the lid and allow temperature stabilization to occur. 3. N  ote the difference in temperature between the incubator temperature display and the probe.

EN-14

Ortho BioVue System Heat Block-32

2013-10-07

Section 6 - Temperature Selection/Correction Procedure, continued Temperature Correction Procedure, continued

4. Place the cassette containing the probe in the other block and repeat actions.

EN

5. If the difference between the display and the probe is greater than ± 0.2°C, enter the temperature correction menu in this way:

Turn OFF the instrument. Turn ON the instrument while depressing the START/STOP key (K6) on the right side of the instrument. Once in the menu, both lower displays will show Co.r1 (left) and Co.r2 (right) and each upper one will show a number from -3.0 to 3.1 corresponding to the factory correction.

The difference previously noted must be added to this number. For example:

Left incubator display 37°C, probe temperature 36.5°C (disp. temp – probe temp) = 0.5°C

Correction display: -1.7;

Correction display new value: (-1.7 + 0.5) = -1.2

Right incubator display 37°C, probe temperature 37.5°C (disp. temp – probe temp) = -0.5°C

Correction display: 1.1;

Correction display new value: (1.1 + (-0.5)) = 0.6

The actual left correction number, -1.7, may be changed by using the UP/DOWN keys to increase or decrease the number. Repeat the same sequence to correct the number on the right side of the instrument. Once the working temperature is selected in each block, depress the left START/ STOP key (K5) to store the temperature in the EEPROM memory.

2013-10-07

Ortho BioVue System Heat Block-32

EN-15

Section 7 - Maintenance Cleaning  The Ortho BioVue System Heat Block-32 requires minimal maintenance to ensure proper, long-term functioning.

EN

It is important not to use abrasive products. Mild detergent is sufficient.  Clean the heating blocks, the metacrilate lids and the keypad with a clean, dry cotton swab moistened with water and mild detergent. Follow instructions in the cassette instructions for use about disposal of cassettes. Replacing Fuses 1. Turn OFF the instrument. 2. Unplug the power cord. 3. Unscrew the fuse tape on the rear panel. 4. Replace the broken fuse with another one of the same type and value. 5. Close the fuse tape. 6. Plug in the power cord and turn ON the instrument. If the instrument does not switch on or the new fuse is not functioning, contact the hotline number provided by your local Ortho-Clinical Diagnostics company or distributor for assistance. Thermometer Verification

Verify accuracy of the glass thermometer according to standard operating procedures.

Timer Verification

Verify accuracy of the timer according to standard operating procedures.

EN-16

Ortho BioVue System Heat Block-32

2013-10-07

Section 8 - Troubleshooting Guide TROUBLESHOOTING Symptom

Possible Cause

Suggested Remedy

Ortho BioVue System Heat Block-32 cannot be turned on

Power cord pulled from the instrument or from the outlet

Verify that the power cord is plugged securely into the power outlet and the Ortho BioVue System Heat Block-32.

Complete power loss

Main power switch in OFF position

If the main power switch is in the OFF position, turn it to the ON position.

Temporary power loss

Line voltage dropped below specifications

If the voltage temporarily drops and then returns to normal, the instrument will reinitialize.

Glass thermometer is not operating

The thermometer is broken or it has been submitted to a very high temperature

Contact the hotline number provided by your local Ortho-Clinical Diagnostics company or distributor for assistance to exchange the instrument.

EN

To determine if the thermometer is operating properly: • Insert a flexible temperature probe into a cassette reaction chamber filled with water. • Place the cassette with water and probe into the incubator. • Compare the temperature of the probe with the temperature indicated on the incubator. If the probe and the incubator display are not registering the same temperature, refer to Section 6. The unit does not turn on. or The display remains dark. or The display blinks on and then off immediately.

The power supply is attempting to use the wrong voltage.

For units with a manual switch, do the following: • Check the switch to make sure it is set correctly. • Replace the fuse. • If the unit still doesn’t work, call for service. For units with an auto-switching power supply, do the following: • Replace the fuse. • If the unit still doesn’t work, call for service. Refer to “Electrical Requirements” on page 10 for more information.

2013-10-07

Ortho BioVue System Heat Block-32

EN-17

Section 9 - Instrument Disinfection

EN

All parts of the instrument that come into contact with the test specimen or control samples must be treated as potentially infectious areas. Follow instructions in the Ortho BioVue System cassette instructions for use regarding disposal of cassettes. It is advisable to wear disposable gloves when performing the washing procedure and also when making adjustments to the instrument. It is very important that the instrument is thoroughly disinfected before it is removed from the laboratory or any servicing is performed on it. Before the instrument is returned to your local Ortho-Clinical Diagnostics company or distributor for servicing, it must be disinfected and a disinfection certificate must be completed and attached. If a disinfection certificate is not supplied, the servicing center may not accept the instrument or it may be held by the customs authorities. Disinfection Procedure  NOTE: If the laboratory has its own disinfection procedure, please contact your local Ortho-Clinical Diagnostics company or distributor to ensure that the procedure will not damage the instrument. If the laboratory has no specific disinfection procedure, the following procedure should be used to disinfect the instrument. The instrument should be disinfected using the following solutions: • Formaldehyde solution: 10% • Alcohol solution: 70% Ensure that the national regulations for the handling of formaldehyde are observed and used. The disinfection procedure should be performed by authorized, trained personnel wearing disposable gloves and protective clothing in a well-ventilated room. 1. Disconnect the instrument from the main power supply. 2. C  arefully wipe all the outside surfaces of the instrument (especially the surfaces of both heating blocks) with a wad of cotton wool that has been soaked in the formaldehyde solution. 3. P  lace the instrument into a large plastic bag. 4. P  lace a wad of cotton wool, which has been soaked in the formaldehyde solution, into the plastic bag. Ensure that the wad is not touching the instrument. 5. C  lose and seal the plastic bag. 6. L et the instrument stand in the plastic bag for at least 24 hours. 7. A  fter the standing time, remove the instrument from the plastic bag and wipe all the outside surfaces of the instrument with a wad of cotton wool that has been soaked in the alcohol solution. 8. C  lean the display area with a mild detergent. 9. A  fter the disinfection procedure has been performed, ensure that the disinfection certificate is completed. (See example of certificate.)

EN-18

Ortho BioVue System Heat Block-32

2013-10-07