BiliBlanket Metter II Operation and Maintenance Manual Rev ZAF 2019

English

User Responsibility 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, Datex-Ohmeda recommends that a telephone call or written request for service advice be made to the nearest Datex-Ohmeda Service center. This product or any of its parts should not be repaired other than in accordance with written instructions provided by Datex-Ohmeda and by Datex-Ohmeda trained personnel. The Product must not be altered without Datex-Ohmeda’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 Datex-Ohmeda. GE Healthcare has declared that this product conforms with the European Council Directive 93/42/EEC Medical Device Directive when it is used in accordance with the instructions provided in the Operation and Maintenance Manual. This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.

Definitions w WARNING: A Warning statement is used when the possibility of injury to the patient or the operator exists. w

CAUTION: 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.

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1/General Information Intended Use/Description The BiliBlanket™ Meter II is a handheld device used for measuring the light output of phototherapy devices. The BiliBlanket Meter II measures the light energy that strikes its photodetector within a fixed spectral region (spectral window). The total energy, or irradiance (µW•cm-2), is divided by the BiliBlanket Meter II’s bandwidth to obtain the spectral irradiance (µW•cm-2•nm-1) of the light source, which is displayed on the LCD. The BiliBlanket Meter II’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. The BiliBlanket Meter II (6600-0198-900) is shipped with a receptor cap, a carrying strap, an O&M manual, and a carrying pouch. Batteries are included.

Relative Spectral Response

Normalized Spectral Response of BiliBlanket Meter II

400

Figure 1-1 Spectral response curve

410

420

430

440

450

460

470

CI.09.009

Active Wavelength Range for Serum Bilirubin

480

490

500

510

520

Wavelength (nm)

Replacement parts: Receptor cap and string...6600-0530-200 Carrying pouch...6600-0531-200 Template for BiliBlanket Plus & High Output*...6600-0500-700 Battery cover...6600-0982-200 * Template is not included in the BiliBlanket Meter II kit and must be ordered separately for the customers who own BiliBlanket™, BiliBlanket™ Plus, and BiliBlanket™ Plus High Output Systems.

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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

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

4. Hold-Run

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

5. On-Off switch

Turns the BiliBlanket Meter II 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.

Ohmeda Medical MADE IN JAPAN

54000101

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xxxxxxxxxxxxxxxxx xxx

Distributed xxxxxxxxxxx by: Ohmeda Medical Columbia, MDxxxxxxxxxx USA xxxxxxxxxxxxxx Produced by: xxxxxxxxxxxx Minolta Co.,xxxxxx Ltd Japan

3 Bil iBl ank et® Me ter II

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wCAUTION: Refer to Operation xxxxxxxx xxxxxxx xxxxx x x xxxxxxxx Manual xxxxxxxxxxx

BATTERY: 1.5V x 2xxx .50mA AC ADAPTER 9Vxxx .50mA xxxxxx xxxxxxxx xxxxxxxxxxx xxxxxx xxxxxxxxxx xxxxxxxxxxxxx xxxxxx

MADE IN JAPAN

xxxxxxx xxxxx xxxxxx

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54000101

BiliBlanket® Meter II

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Figure 1-2 BiliBlanket Meter II

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CI.09.016

CI.09.018

2

CI.09.017

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2/Operation Checkout procedure before operation Perform the following checkout procedure each time the BiliBlanket Meter II is placed into service. 1. Verify that the BiliBlanket Meter II is not overdue for calibration. Calibration is required annually. 2. Clean the receptor dome with lens tissue or a soft dry cloth. 3. Set the Hold/Run switch to the Run ( ) position. 4. Verify that the batteries are installed with the proper polarity and that there is no sign of battery leakage. w CAUTION: 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. w CAUTION: Do not subject the BiliBlanket Meter II 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 continuous 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

Operating Procedures

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2/Operation For the irradiance measurement procedures of any phototherapy device, follow the manufacturer's instructions. 1. Switch on the phototherapy light source and allow it to warm up according to the phototherapy device manufacturer's instructions. 2. Turn on the BiliBlanket Meter II. 3. Set the Hold/Run switch to the Run ( ) position. The BiliBlanket Meter II now performs continuous irradiance measurements. 4. After a few seconds, press the Hold/Run switch push button to set it to its inward Hold ( ) position. This freezes the display reading at the current spectral irradiance level. The BiliBlanket Meter II may now be removed. The measured spectral irradiance data is shown in the display window. w WARNING: Never leave the BiliBlanket Meter II or any of its components in the patient compartment of an incubator, warmer or bassinet. The carrying strap and the lens cover strap can pose a choking or strangulation hazard. Important: The BiliBlanket Meter II 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 BiliBlanket Meter II 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 phototherapy device manufacturer on measuring technique and light meter specifications.

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

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3/Maintenance Cleaning and disinfecting w CAUTION: 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. w CAUTION: Never immerse the BiliBlanket Meter II in liquid. Do not autoclave/ETO BiliBlanket Meter II or receptor head. The electronic circuitry can be short-circuited, causing permanent damage. w CAUTION: Use the cleaning solution sparingly on a cloth when cleaning the exterior of the BiliBlanket Meter II. Do not saturate the unit - excessive solution may flow into the BiliBlanket Meter II causing damage to internal components. 1. Switch off the BiliBlanket Meter II power. 2. Use lens tissue or a soft dry cloth to clean the receptor head. 3. Clean the BiliBlanket Meter II 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 BiliBlanket Meter II surface with a clean, soft cloth. Important: The BiliBlanket Meter II 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 BiliBlanket Meter II provides no readout when operated.

BiliBlanket Meter II displays battery mark above measured value.

Possible Cause The batteries are defective.

Recommended Action Replace the batteries.

The photocell is defective.

Return the BiliBlanket Meter II for repair and calibration.

Batteries installed improperly. Install batteries correctly. The batteries are weak. Replace the batteries.

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 ErrU

Err

ErrC

Description Initial communication error. No response from the receptor head during initial communication. EEPROM error. Error with the EEPROM data (in the receptor head)

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

Remove the batteries (or AC adapter), then re-install them. If this message reappears, contact the nearest authorized service facility. Communication error (mainCheck connection. If the instrument is conbody receptor head). Com- nected properly, contact the nearest authomunication between the main rized service facility. body and receptor head was not performed properly.

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 DatexOhmeda will reflect Datex-Ohmeda’s then current list price for replacement parts, labor charges, and travel charges where applicable.

Calibration The BiliBlanket Meter II 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 BiliBlanket Meter II with that lamp standard. Yearly calibration of the BiliBlanket Meter II is required. All repairs must be verified by calibration with traceable equipment. Contact an authorized service facility. 8

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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•cm-2•nm-1.

Measuring range:

Spectral irradiance:

0.1 ~ 299.9 µW•cm-2•nm-1.

Accuracy:

Within ±3% of reading ±1 digit in the last position.

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 BiliBlanket Meter II is not to be used for two or more weeks, it is recommended that the batteries be removed to prevent leakage. When replacing the batteries, do not mix old batteries and new batteries. Observe proper battery polarity. † Storing the BiliBlanket Meter II in temperatures outside this temperture range may affect performance and damage the unit.

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Warranty This Product is sold by Datex-Ohmeda under the warranties set forth in the following paragraphs. Such warranties are extended only with respect to the purchase of this Product directly from DatexOhmeda or Datex-Ohmeda’s Authorized Dealers as new merchandise and are extended to the first Buyer thereof, other than for purpose of resale. For a period of twenty-four (24) months from the date of original delivery to Buyer to Buyer’s order, or to an Datex-Ohmeda 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 Datex-Ohmeda or in accordance with written instructions provided by Datex-Ohmeda, or altered by anyone other than Datex-Ohmeda, or if the Product has been subject to abuse, misuse, negligence, or accident. Datex-Ohmeda’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 Datex-Ohmeda’s option, a Product, which is telephonically reported to the nearest Datex-Ohmeda Regional Service Office and which, if so advised by Datex-Ohmeda, 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 Datex-Ohmeda Service Office during normal business hours, transportation charges prepaid, and which, upon Datex-Ohmeda’s examination, is found not to conform with the above warranties. Datex-Ohmeda 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. Datex-Ohmeda makes no warranty of merchantability or fitness for a particular purpose with respect to the product or parts thereof.

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Korean

공란

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