Ohmeda BiliBlanket Meter 2 Operation and Maintenance Manual April 2000

User Responsibility

Warranty

This product will perform in conformity with the description thereof contained in this manual and accompanying labels and/or inserts, when assembled, operated, maintained and repaired in accordance with the instructions provided. This product must be checked periodically. A malfunctioning Product should not be used. Parts that are broken, missing, plainly worn, distorted or contaminated should be replaced immediately. Should repair or replacement become necessary, Ohmeda Medical recommends that a telephonic or written request for service advice be made to the nearest Ohmeda Medical Service center. This product or any of it’s parts should not be repaired other than in accordance with written instructions provided by Ohmeda Medical and by Ohmeda Medical trained personnel. The Product must not be altered without Ohmeda Medical’s prior written approval. The user of this Product shall have the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than Ohmeda Medical.

This Product is sold by Ohmeda Medical under the warranties set forth in the following paragraphs. Such warranties are extended only with respect to the purchase of this Product directly from Ohmeda Medical or Ohmeda Medical’s Authorized Dealers as new merchandise and are extended to the first Buyer thereof, other than for purpose of resale.

wCAUTION: US Federal law restricts this device to sale by or on the order of a licensed medical practitioner

Definitions wWARNING: A Warning statement is used when the possibility of injury to the patient or the operator exists. wCAUTION: A Caution statement is used when the possibility of damage to the equipment exists. Important: An Important statement is similar to a note but is used for greater emphasis. Note: A Note provides additional information to clarify a point in the text.

For a period of twenty-four (24) months from the date of original delivery to Buyer to Buyer’s order, or to an Ohmeda Medical Authorized Dealer, this Product, other than its expendable parts, is warranted to be free from functional defects in materials and workmanship and to conform to the description of the Product contained in the service manual and accompanying labels and/or inserts, provided that the same is properly operated under conditions of normal use, that regular periodic maintenance and service is performed and that replacements and repairs are made in accordance with the instructions provided. This same warranty is made for a period of sixty (60) days with respect to the expendable parts. The foregoing warranties shall not apply if the Product has been repaired other than by Ohmeda Medical or in accordance with written instructions provided by Ohmeda Medical, or altered by anyone other than Ohmeda Medical, or if the Product has been subject to abuse, misuse, negligence, or accident. Ohmeda Medical’s sole and exclusive obligation and Buyer’s sole and exclusive remedy under the above warranties is limited to repairing or replacing, free of charge, at Ohmeda Medical’s option, a Product, which is telephonically reported to the nearest Ohmeda Medical Regional Service Office and which, if so advised by Ohmeda Medical, is thereafter returned with a statement of the observed deficiency, not later than seven (7) days after the expiration date of the applicable warranty, to the designated Ohmeda Medical Service Office during normal business hours, transportation charges prepaid, and which, upon Ohmeda Medical’s examination, is found not to conform with the above warranties. Ohmeda Medical shall not be otherwise liable for any damages including, but not limited to incidental damages, consequential damages, or special damages.

There are no express or implied warranties which extend beyond the warranties hereinabove set forth. Ohmeda Medical makes no warranty of merchantability or fitness for a particular purpose with respect to the product or parts thereof.

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1/General Information Description The Ohmeda BiliBlanket Meter measures the light energy that strikes its photodetector within a fixed spectral region (spectral window). The total energy, or irradiance (µW/cm2), is divided by the radiometer’s bandwidth to obtain the spectral irradiance (µW/cm2/nm) of the light source, which is displayed on the LCD. The BiliBlanket Meter’s spectral window matches the wavelength range current clinical knowledge accepts as optimally affecting serum bilirubin level (phototherapeutic light). Figure 1-1 shows the total system response. Various manufacturer’s radiometers have different spectral windows, so they give different spectral irradiance values for the same light source, even when their window differences are small.

Relative Spectral Response

Normalized Spectral Response of Ohmeda BiliBlanket Meter

400

410

420

430

440

450

460

470

480

490

500

510

520

Wavelength (nm)

CI.09.009

Active Wavelength Range for Serum Bilirubin

Figure 1-1 Spectral response curve The Ohmeda BiliBlanket Meter (6600-0198-900) is shipped with a receptor cap, a carrying strap, an O&M manual, a BiliBlanket Plus template, and a carrying pouch. Batteries are included. Replacement parts: Turn adapter accessory (reverses receptor head 180°) ... 6600-0270-800 Receptor cap and string ... 6600-0530-200 Carrying pouch ... 6600-0531-200 Template for BiliBlanket ... 6600-0383-700 Template for BiliBlanket Plus & High Output ... 6600-0500-700

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1/General Information Operating controls and indicators 1.

Display window

Displays the spectral irradiance data.

2.

Light receptor dome

Covers the light sensing photocell.

3.

Receptor head release button

When depressed, the release button permits removal of the receptor head.

4.

Hold-Run measuring switch

Pressing switch to its inward position selects its Hold ( J ) function, freezing the display reading at the last irradiance level received. Pressing again releases the push button to its upward Run ( j ) position, allowing display of continuous irradiance measurements.

5.

On-Off switch

Turns the radiometer on and off.

6.

Battery cover

Remove by sliding the cover down as indicated by the arrow on the cover.

7.

Receptor Cap

Protects receptor head. Attach as indicated in Figure 1-2.

CI.09.016

7 2 Ohmeda Medical

1

54000101

CI.09.017

CI.09.018

MADE IN JAPAN

Distributed by: Ohmeda Medical Columbia, MD USA Produced by: Minolta Co., Ltd Japan

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wCAUTION: Refer to Operation Manual BATTERY: 1.5V x 2xxx .50mA AC ADAPTER 9Vxxx .50mA MADE IN JAPAN

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54000101

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Figure 1-2 Ohmeda BiliBlanket Meter 2

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2/Operation Checkout procedure before operation Perform the following checkout procedure each time the Ohmeda BiliBlanket Meter is placed into service. 1. Verify that the radiometer is not overdue for calibration. Calibration is required annually from the date of purchase. 2. Clean the receptor dome with lens tissue or a soft dry cloth. 3. Set the Hold/Run switch to the Run ( j ) position. 4. Verify that the batteries are installed with the proper polarity. wCAUTION: Improper installation of the battery will cause the unit to malfunction. 5. Set the On/Off switch to the On position. 6. Zero adjustment is performed automatically when the switch is set to “I” (ON). • “CAL” will be displayed during zero adjustment. •

Zero adjustment is performed electronically, so no cap is required

•

When zero adjustment is complete, CAL message will disappear.

wCAUTION: Do not subject the radiometer to shocks or vibration, especially at the time of zero-level adjustment. Inaccurate readings may result. 7. Install new batteries if either of the following occurs: • The display window is blank, or • A battery mark will appear above the measured value. If you continue to use the instrument, the mark will start to blink and measurement will no longer be possible. Note: Use of fresh alkaline batteries enables continous measurement for approximately 72 hours or more at normal temperatures.

100.0

CI.09.019

µm•cm-2•nm-1

Figure 2-1 Battery Alarm 3

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2/Operation Operation procedure with BiliBlanket® , BiliBlanket Plus, and BiliBlanket High Output Phototherapy System 1. Be certain the checkout procedure for the Ohmeda BiliBlanket has been completed. 2. Be certain the checkout procedure for the Ohmeda BiliBlanket Meter has been completed. 1.

Average Output= (A+B+C+D+E+E) 6

2. A

E

D

Figure 2-2 Using the template

A C

E

B D

CI.09.011

45°

3.

3. Position the BiliBlanket pad on a flat surface with the light-emitting side up. 4. Switch on the BiliBlanket Illuminator and allow to warm up approximately 15 minutes. 5. Install the template on the light pad as shown in Figure 2-2, step 1, making sure that the pad slides all the way into the template. 6. Using the brightness selector switch on the Illuminator front panel, select the high light intensity setting. 7. Turn on the BiliBlanket Meter. 8. Set the Hold/Run switch to the Run ( j ) position. The radiometer now performs continuous irradiance measurements. 9. Using the template, place the radiometer’s receptor dome in contact with the surface area of the Illuminator pad, as shown in Figure 2-2, step 2. 10.After a few seconds, press the Hold/Run switch push button to set it to its inward Hold ( J ) position. This freezes the display reading at the current spectral irradiance level received from the pad. The radiometer may now be removed. The measured spectral irradiance data is shown in the display window. Repeat the measurement for the five locations as shown in Figure 2-2, step 3. To obtain the average irradiance value, add the five readings together (A+B+C+D+E) and the center reading again (E), then divide the sum by six [(A+B+C+D+E+E)/6]. 11. Switch off the BiliBlanket Illuminator power. 12. Switch off the radiometer power if no additional measurements are to be made. 4

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2/Operation 70

Meter Reading

60 50 40 30 20 10 Units @ 120V~ Units @ 220V~ Units @ 230V~ Units @ 240V~ Units @ 100V~

100 191 200 209 83

105 201 210 219 87

110 210 220 230 91

115 220 230 240 95

120 230 240 250 99

125 239 250 261 103

130 249 260 271 107

Measured Line Voltage

Figure 2-3 Meter Reading vs Line Voltage 13. For BiliBlanket systems,use an AC volt meter to measure the line voltage of the receptacle that the BiliBlanket will be plugged into (BiliBlanket Plus and BiliBlanket Plus High Output systems are equipped with an internal voltage regulator which make measuring line voltage unnecessary). Use the chart in Figure 2-3 to determine if the BiliBlanket is emitting the correct light output. Draw a vertical line from the line voltage axis, starting at the line voltage measured at the power receptacle from step 3 (as the chart shows, the values on the line voltage axis vary depending on the rated voltage of the BiliBlanket). Then draw a horizontal line from the meter reading axis, starting at the obtained spectral irradiance value. If the two lines intersect within the shaded area of the chart, then the BiliBlanket has the correct irradiance output. Note: If you can not determine or measure line voltage, readings between 18 - 63 are considered within specification. Note: For BiliBlanket Plus systems, meter readings should be between 26.25 and 43.75 µW/cm2/nm. For BiliBlanket Plus High Output systems, meter readings should be between 34.75 and 56.25 µW/cm2/nm. Important: The Ohmeda Medical BiliBlanket Light Meter is calibrated with a traceable tungsten lamp source. This calibration assures the accuracy of the meter with that lamp standard. When measuring other types of light sources, the meter may not accurately measure the specified spectral irradiance, as it is not calibrated for the spectral distribution of that lamp. Refer to the recommendations provided by the manufacturer on measuring technique and light meter specifications. 5

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2/Operation Over-range Error If the measured irradiance exceeds the measuring range, “-0-” will blink to inform you that an over range error has occured.

Operation procedure for conventional phototherapy lamps 1. Be certain the checkout procedure for the Ohmeda BiliBlanket Meter has been completed. 2. Set the Hold/Run switch to the Run ( j) position. The radiometer now continuously measures irradiance. 3. Expose the light meter receptor to the light beam in the area representative of the infant’s position. When measuring spectral irradiance of an incandescent phototherapy lamp, position the radiometer receptor at the center of the beam. 4. After a few seconds, press the Hold/Run switch to its inward Hold (J) position. This freezes the display reading at the current spectral irradiance level. 5. The radiometer may now be moved away from the measurement area. The measured irradiance data will remain on the display window. 6. Switch off the radiometer power if no additional measurements are to be made.

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3/Maintenance Cleaning and disinfecting wCAUTION: Do not use cleaning solutions with an iodine base or any solution which may cause discoloration. A discolored light receptor dome may reduce the amount of light entering the receptor and alter the accuracy of this device. wCAUTION: Never immerse the Ohmeda BiliBlanket Meter in liquid. Do not autoclave/ETO radiometer, receptor head or turn adapter. The electronic circuitry can be short-circuited, causing permanent damage. wCAUTION: Use the cleaning solution sparingly on a cloth when cleaning the exterior of the Ohmeda BiliBlanket Meter. Do not saturate the unit excessive solution may flow into the radiometer causing damage to internal components. 1. Switch off the radiometer power. 2. Use lens tissue or a soft dry cloth to clean the receptor head. 3. Clean the radiometer exterior using a mild detergent solution applied with a damp cloth or sponge. Aqueous solutions which are both hospital disinfectants and mycobactericides may be used. A quaternary amine disinfectant-detergent registered by the U.S. Environmental Protection Agency may be used. 4. Dry the radiometer surface with a clean, soft cloth. Important: The radiometer must be calibrated annually to ensure the accurate measurement of therapeutic light sources. All repairs must be verified by calibration by a repeatable transfer from a master meter calibrated to NIST or ETL (Japan’s equivalent of NIST) traceable light sources. Contact the nearest authorized service facility.

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4/Troubleshooting Table 4-1 Troubleshooting guide Symptom:

Possible Cause:

Recommended Action:

Radiometer provides no readout when operated.

The batteries are defective.

Replace the batteries.

The photocell is defective.

Return the radiometer for repair and calibration.

Batteries installed improperly

Install batteries correctly.

The batteries are weak.

Replace the batteries.

Radiometer displays battery mark above measured value.

Error Messages An error may occur during operation due to some problems. If an error occurs, refer to the table below and take the necessary action.

Message:

Description:

Recommended Action:

ErrU

Initial communication error No response from the receptor head during initial communication

Check connection. If the instrument is connected properly, contact the nearest authorized service facility.

Err

EEPROM error Error with the EEPROM data (in the receptor head)

Remove the batteries (or AC adapter), then re-install them. If this message reappears, contact the nearest authorized service facility.

ErrC

Communication error (main body ˆ receptor head) Communication between the main body and receptor head was not performed properly.

Check connection. If the instrument is connected properly, contact the nearest authorized service facility.

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4/Troubleshooting Calibration/Repair policy and procedure In-Warranty Repair, service and calibration of equipment under warranty should be performed by an authorized service facility. Service performed or attempted by unauthorized personnel may void the warranty. All repairs must be verified by calibration. Refer to the warranty statement for further details. Out-of-Warranty To promote full reliability, have all repairs, service and calibration performed by an authorized service facility. All repairs must be verified by calibration. All out-of-warranty repairs performed by Ohmeda Medical will reflect Ohmeda Medical’s then current list price for replacement parts, labor charges and travel charges where applicable. Calibration The Ohmeda Medical BiliBlanket Meter must be calibrated with a master meter calibrated to NIST or ETL (Japan’s equivalent of NIST) traceable light sources. This calibration assures the accuracy of the radiometer with that lamp standard. Yearly calibration of the Ohmeda Medical BiliBlanket meter is required. All repairs must be verified by calibration with traceable equipment. Contact an authorized service facility.

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5/Specifications Note: All specifications are nominal and are subject to change without notice. Spectral response:

Range:

400 to 520 nm.

Center wavelength:

450 nm.

Bandwidth:

60 nm.

Light acceptance angle cosine characteristics:

± 2% at 30° angle; ± 7% at 60° angle; ± 25% at 80° angle.

Receptor type:

Silicon photocell.

Display type:

Liquid crystal display.

Measuring functions:

Spectral irradiance:

µW/cm2/nm.

Measuring range:

Spectral irradiance:

0.1 ~ 299.9 µW/ cm2/nm. Within ±3% of full scale ±1 digit in the last position.

Accuracy:

Temperature range:

Operating:

–10 to 40°C† (14 to 104°F)

Physical:

Dimensions:

174 x 69 x 35 mm

Weight (nominal):

180 g without battery.

Internal battery:

Two 1.5 volt, alkaline.

Battery life:

Approximately 72 hours.*

Power source:

*

If the radiometer is not to be used for two or more weeks, it is recommended that the batteries be removed.

†

Storing the radiometer in temperatures outside this temperture range may affect performance and damage the unit.

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Notes

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Notes

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User Responsibility

Warranty

This product will perform in conformity with the description thereof contained in this manual and accompanying labels and/or inserts, when assembled, operated, maintained and repaired in accordance with the instructions provided. This product must be checked periodically. A malfunctioning Product should not be used. Parts that are broken, missing, plainly worn, distorted or contaminated should be replaced immediately. Should repair or replacement become necessary, Ohmeda Medical recommends that a telephonic or written request for service advice be made to the nearest Ohmeda Medical Service center. This product or any of it’s parts should not be repaired other than in accordance with written instructions provided by Ohmeda Medical and by Ohmeda Medical trained personnel. The Product must not be altered without Ohmeda Medical’s prior written approval. The user of this Product shall have the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than Ohmeda Medical.

This Product is sold by Ohmeda Medical under the warranties set forth in the following paragraphs. Such warranties are extended only with respect to the purchase of this Product directly from Ohmeda Medical or Ohmeda Medical’s Authorized Dealers as new merchandise and are extended to the first Buyer thereof, other than for purpose of resale.

wCAUTION: US Federal law restricts this device to sale by or on the order of a licensed medical practitioner

Definitions wWARNING: A Warning statement is used when the possibility of injury to the patient or the operator exists. wCAUTION: A Caution statement is used when the possibility of damage to the equipment exists. Important: An Important statement is similar to a note but is used for greater emphasis. Note: A Note provides additional information to clarify a point in the text.

For a period of twenty-four (24) months from the date of original delivery to Buyer to Buyer’s order, or to an Ohmeda Medical Authorized Dealer, this Product, other than its expendable parts, is warranted to be free from functional defects in materials and workmanship and to conform to the description of the Product contained in the service manual and accompanying labels and/or inserts, provided that the same is properly operated under conditions of normal use, that regular periodic maintenance and service is performed and that replacements and repairs are made in accordance with the instructions provided. This same warranty is made for a period of sixty (60) days with respect to the expendable parts. The foregoing warranties shall not apply if the Product has been repaired other than by Ohmeda Medical or in accordance with written instructions provided by Ohmeda Medical, or altered by anyone other than Ohmeda Medical, or if the Product has been subject to abuse, misuse, negligence, or accident. Ohmeda Medical’s sole and exclusive obligation and Buyer’s sole and exclusive remedy under the above warranties is limited to repairing or replacing, free of charge, at Ohmeda Medical’s option, a Product, which is telephonically reported to the nearest Ohmeda Medical Regional Service Office and which, if so advised by Ohmeda Medical, is thereafter returned with a statement of the observed deficiency, not later than seven (7) days after the expiration date of the applicable warranty, to the designated Ohmeda Medical Service Office during normal business hours, transportation charges prepaid, and which, upon Ohmeda Medical’s examination, is found not to conform with the above warranties. Ohmeda Medical shall not be otherwise liable for any damages including, but not limited to incidental damages, consequential damages, or special damages.

There are no express or implied warranties which extend beyond the warranties hereinabove set forth. Ohmeda Medical makes no warranty of merchantability or fitness for a particular purpose with respect to the product or parts thereof.

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Ohmeda Medical 8880 Gorman Road Laurel MD 20723 USA 410-381-2555

North America

United States Customer Service and Distribution Center Datex-Ohmeda, Inc. Ohmeda Drive PO Box 7550 Madison, WI 53707-7550 Tel 1 800 345 2700 Fax 1 608 221 4384 Technical Support Datex-Ohmeda, Inc. Three Highwood Drive Tewksbury, MA 01876 Tel 1 800 345 2755 Sales and Service Datex-Ohmeda, Inc. Three Highwood Drive Tewksbury, MA 01876 Tel 1 800 635 6099 Fax 1 978 640 0469 Equipment Service Center Datex-Ohmeda, Inc. 1315 West Century Drive Louisville, CO 80027-9560 Tel 1 800 345 2755 Canada Dynamed Health Care Systems 235 Shields Court Markham, Ontario L3R 8V2 Canada Toll Free 800 227 7215 Tel 905 752 3300 Fax 905 752 3304

Asia/Pacific Japan Datex-Ohmeda K. K. TRC Annex 9F 6-1-1 Heiwajima Ohta-ku, Tokyo 143-0006 Japan Tel 81 3 5763 6801 Fax 81 3 5763 6838 Datex-Ohmeda K. K. Technical Center TRC A Bldg. AE 4-8 6-1-1 Heiwajima Ohta-ku, Tokyo 143-0006 Japan Tel 81 3 5763 6850 Fax 81 3 5763 6852

Malaysia Datex-Ohmeda 13 Jalan 223 Level 2 Bangunan O'connors 46100 Petaling Jaya Selangor, Malaysia Tel 60 3 754 7872 Fax 60 3 757 6948 Singapore Datex-Ohmeda Pte. Ltd. 152 Beach Road #12-05/07 Gateway East Singapore 189721 Tel 65 391 8618 Fax 65 291 6618

Australia Datex-Ohmeda Pty. Ltd. Units 1 & 2 149 Arthur Street P O Box 356 Homebush NSW 2140 Australia Tel 61 132 229 Fax 61 297 461796

India Datex-Ohmeda (India) Pvt. Ltd. Block EP & GP, Sector V Plot XI-16, Salt Lake Calcutta 700091 India Tel 91 33 3574002 Fax 91 33 3574001

Europe France Datex-Ohmeda S.A.S. 17 rue Jean-Elysée Dupuy F-69410 Champagne Au Mont d'Or France Tel 33 01 30 68 60 00 Fax 33 04 78 43 26 58 Germany Datex-Ohmeda GmbH Dr-Alfred-Herrhausen-Allee 24 D-47228 Germany Tel 49 2065 691 0 Fax 49 2065 691 236

Italy Datex-Ohmeda S.p.A. Via Cassanese, 100 20090 Segrate, Milan Italy Tel 39 2 21693431 Fax 39 2 26926226 Netherlands Datex-Ohmeda B.V. Kantemarsweg 18 Post Box 22 3870 CA Hoevelaken Netherlands Tel 31 33 253 5404 Fax 31 33 253 7223

BiliBlanket® Meter II Operation and Maintenance Manual

Spain Datex-Ohmeda S.L. C/Manuel Tovar 26 28034 Madrid Spain Tel 34 1 334 26 00 Fax 34 1 358 12 84 United Kingdom Datex-Ohmeda Ltd. Ohmeda House 71 Great North Road Hatfield Hertfordshire AL9 5EN England Tel 44 1707 263570 Fax 44 1707 260191

Latin America, Caribbean Datex-Ohmeda Latin America 10685 North Kendall Drive Miami, FL 33176 USA Tel 1 305 273 9940 Fax 1 305 273 4382

Middle East Datex-Ohmeda Middle East Operations P O Box 5527 Dubai United Arab Emirates Tel 97 14 822653 Fax 97 14 822659

6600 0350 000 04 00 0 13 10 06 Printed in USA © Ohmeda Medical

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