This Product will perform in conformity with the description thereof contained in this
operating 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 defective Product should not be used. Parts that are
broken, missing, plainly worn, distorted or contaminated should be replaced immediately. Should such repair or replacement become necessary, Ohmeda recommends
that a telephone or written request for service advice be made to the nearest Ohmeda
Regional Service Center. This Product or any of its parts should not be repaired other
than in accordance with written instructions provided by Ohmeda and by Ohmeda
trained personnel. The Product must not be altered without 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 Ohmeda.
CAUTIONw Federal law in the USA and Canada restricts this device to sale by or on the
order of a licensed medical practitioner.
ii6600 0341 00004/25/00
Table of Contents
1/General Information ..................................................................................................... 1
The skin serves as a protective barrier against chemical, mechanical, and biological
insults. The skin is also important in the regulation of body temperature and serves as
a route of water excretion, especially in premature infants. The introduction of new
intensive-care techniques has been associated with the increased survival of very
small, premature infants. The immaturity of the skin of the very low weight infants,
coupled with excessive instrumentation and handling, poses previously unrecognized
problems for the nursing care of these infants1.
Please read, evaluate and implement the following recommendations as appropriate:
1. Please refer to the following standard of skin care recommendations as given in the
literature2 when utilizing this device with all infants. Special attention should be
given to sanitation and skin integrity.
• Observe color, rashes, excoriation
• Clean skin with warm water
• Clean perineal area after stooling
• Change infant’s position every 2 hours
2. This device is intended only for the treatment of existing hyperbilirubinemia. Use of
this device for prophylactic treatment, particularly of premature infants, is not
recommended. These infants have extremely fragile skin3 and various clinical
studies have produced inconsistent conclusions concerning the effectiveness of
prophylactic phototherapy treatment
4 5
.
1
NAACOG(1992), OGN Nursing Practice Resource, Neonatal Skin Care, NAACOG.
2
ibid
3
Rutter, N., The immature skin, British Medical Bulletin, Vol. 44, No. 4, 1988
4
Curtis-Cohen, M., et al, Randomized trial of prophylactic phototherapy in the infant with very low birth weight, TheJournal
of Pediatrics, July, 1985
5
Brown, A., et al, Efficacy of Phototherapy in Prevention and Management of Neonatal Hyberbilirubinemia, Pediatrics,
February , 1988
iiii6600 0341 00004/25/00
General Precautions
Definitions
What the attentionNext to each warning or caution, we have placed an “attention, read
symbol meansaccompanying documents” symbol to alert you to the presence
of these important statements. This is the attention symbol:
w
When the attention symbol appears in front of text that is printed on the system itself,
it means that the text is elaborated upon in the operation manual.
WARNING: A Warning statement is used when the possibility of injury to the patient or
the operator exists.
CAUTION: A Caution statement is used when the possibility of damage to the equipment exists.
~Indicates alternating current.
mIndicates IEC Type B equipment.
TThis letter appearing before a fuselink value indicates a time delay fuselink.
Important: An Important statement is similar to a note but is used for greater emphasis.
Note: A Note provided additional information to clarify a point in the text.
The following are general Warnings and Cautions. Precautions specific to
certain procedures are found in the text of the manual.
WARNINGSw
Do not use the BiliBlanket Plus Phototherapy System in the presence of flammable
anesthetics; a possible explosion hazard exists under these conditions.
Service described in this manual must be performed by a technically competent
individual as described in this manual. Detailed drawings and procedures for more
extensive repairs are included in this manual solely for the convenience of qualified
personnel having proper knowledge, tools and test equipment, or for Ohmeda service
representatives.
CAUTIONSw
Servicing of this product in accordance with this service manual should never be
undertaken without the proper tools, test equipment and the most recent revision of this
service manual which is clearly and thoroughly understood.
Light source controls, indicators and connectors.........................................................1-4
Light source and pad...........................................................................................1-4
Light source back panel ......................................................................................1-5
Accessories and replacement parts.............................................................................1-5
WARNING
Description
ww
w Do not turn on or operate the BiliBlanket Plus High Output Phototherapy
ww
System in the presence of a flammable anesthetics; a possible explosion
hazard exists under these conditions.
General Information
This manual describes how to checkout, operate and maintain the Ohmeda BiliBlanket
Plus High Output Phototherapy System. It also describes for the technically competent
person how to service the BiliBlanket Plus High Output.
Before using the BiliBlanket Plus High Output Phototherapy System
• Read through sections one through three of this manual.
• Pay special attention to the Warnings and Cautions which appear in the manual.
• Read the User Responsibility statement located on the inside front cover; it de-
scribes what is expected of the user to maintain a safe and accurate product.
• Read the Warranty; it describes Ohmeda’s responsibility in case of a functional
defect.
Keep this manual available for answering questions which may arise.
The new BiliBlanket Plus High Output pad, which can be identified by the gray cable,
provides higher intensity levels than the original BiliBlanket Plus High Output pad with the
white cable. Both pads can be used with the BiliBlanket Plus High Output or BiliBlanket
Plus High Output light source box, however, the pad with the white cable will provide lower
intensity levels.
The Ohmeda BiliBlanket Plus High Output Phototherapy System uses a fiber optic cable
to deliver light from a high intensity lamp to a woven fiber optic pad. The pad is placed in a
disposable cover that is in contact with the patient. The patient is exposed to light in the
ideal 400 to 550 nanometer range for phototherapy treatment.
On units with the transilluminator option, unfiltered light in the visible spectrum travels
through a flexible light pipe to appear at the tip of the transilluminator cable. The light from
the cable is used to facilitate vascular sticks or injections. It is also used to find pneumothoraces.
The BiliBlanket Plus High Output Phototherapy system consists of a light source unit and
a light pad with a four foot long fiber optic cable. The light source unit contains a lamp, light
filters, a variable power supply for the light source, a cooling system and overheating
protection near the lamp.
The light source lamp is a high intensity, tungsten halogen bulb with a built-in reflector.
The reflector is coated with a dichroic surface which reduces the infrared energy
transmitted. This bulb is specifically manufactured for use with the BiliBlanket Plus High
Output.
1-11-16600 0341 00004/25/00
1/General Information
A light filter, positioned in front of the lamp, rejects light outside the 400 to 550 nanometer range. This filter blocks nearly all ultra-violet and infrared light; only the blue light is
allowed to pass. This filtered light is focused on the inlet of the fiber optic cable.
Light intensity may be selected by the front panel brightness rotary control. Control
range is from 19± 4.75 µW/cm2/nm at full counter clockwise to 45± 11.25 µW/cm2/nm
at full clockwise with a medium detent at 32± 8 µW/cm2/nm. See Light Output Measurement Procedures in Section 4 for precise light output measurement.
Mode select
Selects the operating mode ; phototherapy or transillumination. Using the Ohmeda
transilluminator light pipe, the BiliBlanket Plus High Output System can be used as a
transilluminator.
Supply power
Power for the light source unit can be supplied by any standard AC mains power
source at either 50 or 60 Hz that have voltages in the range: 90 - 132 or 180 - 264.
Power enters the light source through a receptacle that has an integral power switch.
Cooling
A fan cools the light source unit. A thermal cutout switch located next to the light-filter
protects the light source unit and fiber optic cable or transilluminator from overheating.
Fiber optic cable
The fiber optic cable contains 2400 individual plastic fibers which transmit the light from
the light source to the light pad. The light pad is constructed by weaving these fibers
into a mat. This patented process produces a pad with light over the entire surface.
These fibers are randomized in the cable to eliminate any local intensity gradients due
to bulb hot spots, dust on the filter, dust on the cable end, etc. This allows the nearly
uniform, continuous blanket of light. A disposable protective pad cover is provided to
reduce the risk of cross-contamination and make the patient more comfortable.
Disposable cover
The disposable cover is designed for use with both premature and full-term infants. The
infant lies directly on the disposable-covered pad without any method of attachment
between the pad and the infant.
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1/General Information
Disposable vest
A disposable vest is designed to secure the fiber optic pad to the infant. With the
disposable vest, it is possible to hold and nurse the infant while continuing phototherapy treatment. The disposable cover should be used for premature infants and fullterm infants who can’t tolerate having the vest secured around the midsection.
Transilluminator
The transilluminator light pipe contains plastic fibers which transmit light from the light
source to the tip.
1-31-36600 0341 00004/25/00
1/General Information
Light source controls, indicators and connectors
8
7
1
Transilluminator Unit
65432
4
6321
Figure 1-1
Light source, pad and transilluminator cable
1-41-46600 0341 00004/25/00
CI.29.001,.002
Nontransilluminator Unit
1/General Information
Refer to Figure 1-1.
Power indicator
1. The green light-emitting diode (LED) lights when the light source unit power is on.
Air flow failure indicator
2. The red light-emitting diode (LED) lights when there is an air flow failure.
Timer
3. Nonresettable timer runs whenever the bulb is turned on.
Brightness selector
4. The rotary control selects the light intensity, and has a center detent at the medium
intensity position. (see Table 1-1 for light intensity values).
Mode select
5. The mode select slide selects the operating mode: phototherapy or transilluminator.
Light source port
6. The light source port is for attaching the fiber optic cable connector or transillumina-
tor.
Pad assembly
7. The pad assembly attaches to the light source port. Light is fed through the optical
fiber cable to the optical fiber woven pad.
Transilluminator cable
8. The cable attaches to the light source port. Light appears at the tip.
BiliBlanket Plus High Output
Phototherapy System
CI..29.003
12
Figure 1-2
Light source back
Refer to Figure 1-2.
Power cord receptacle
1.The power cord plugs into the power cord receptacle.
Power switch
2.The power switch switches the light source unit on.
1-51-56600 0341 00004/25/00
1/General Information
Accessories and replacement parts
Table 1-2
Stock numberItem
6600-0213-800Carrying case
6600-0270-200Disposable covers (50)
6600-0461-200Disposable vest (50)
6700-0025-800Mobile stand, less accessories
6700-0014-800Mobile stand slide bracket assembly, female
6600-1974-101User card
6600-0656-801Pad assembly, English
6600-0656-802Pad assembly, French
6600-0656-803Pad assembly, Spanish
6600-0656-804Pad assembly, German
6600-0656-805Pad assembly, Italian
6600-0656-806Pad assembly, Swedish
6600-0656-807Pad assembly, Japanese
6600-0656-808Pad assembly, Russian
6600-0656-809Pad assembly, Greek
6600-0656-810Pad assembly, Dutch
6600-0656-811Pad assembly, Portuguese
6600-0730-207Power Cord, North America (120V)
6050-0002-259Power Cord, United Kingdom
6030-0000-006Power Cord, Continental Europe
6600-0522-800Transilluminator
6600-0031-900Dovetail rail mount slide bracket kit, female (See A, Figure 1-3)
6600-0198-800Dovetail rail mount slide bracket accessory, male* (See B, Figure 1-3)
6600-0680-200Replacement lamps (6)
6600-0531-800Transilluminator or accessories pouch
* Allows the BiliBlanket Plus High Output to be attached to the dovetail rail mount slide bracket by using two of the
mounting screws on the left side of the light source unit.
B
6600-0198-800
A
6600-0031-900
CI.01.032,033
Figure 1-3
Slide mounting bracket accessory slides into a dovetail mount slide bracket
Dovetail rail systems are used to mount accessories on Ohio® Care Plus® incubators
and Infant Warmer Systems.
1-61-66600 0341 00004/25/00
2/Operation
2/Operation
In this section
Checkout procedure before operation .........................................................................2-2
Using the BiliBlanket Plus High Output Phototherapy System ....................................2-3
Using the Transilluminator ...........................................................................................2-6
WARNING
ww
w Do not use the BiliBlanket Plus High Output Phototherapy System in the
ww
presence of flammable anesthetics; a possible explosion hazard exists
under these conditions.
Factors which affect light output and life
Lamp light output and life are affected by various factors among which are:
• Lamp variations
• Brightness selector setting
• Vibration and mechanical shock
• Non-recommended lamp
Bulb variations
The light output from bulb to bulb may vary by as much as 10%.
Intensity setting
The bulb life will vary greatly with the intensity at which the light source is operated. For
example, operating at the lowest brightness setting may yield a nominal bulb life of as
high as 10,000 hours, but operating at the highest brightness setting may yield a
nominal bulb life of as low as 800 hours.
Vibration and mechanical shock
Vibration and mechanical shock will significantly reduce the bulb life. Care should be
taken when moving the light source. To maximize the bulb life, the light source should
be mounted or placed on a surface which is stable and not exposed to vibration.
CAUTIONSw Allow the light source to cool for a minimum of ten minutes before moving the
light source or changing the bulb.
w To ensure the proper operation and light intensity, replace the lamp only with
the proper lamp as listed in the Appendix. Use of other lamps will affect the
performance of and may result in damage to the BiliBlanket Plus High Output
Phototherapy System.
w Use only Ohmeda light pad assemblies or transilluminator cables. Light pads or
transilluminators from other manufacturers can affect performance and may
damage the unit.
2-12-16600 0341 00004/25/00
2/Operation
Non-recommended lamps
Using any lamp other than that recommended and distributed by Ohmeda for the
BiliBlanket Plus High Output system will affect the performance of and may result in
damage to the light source or the fiber optic pad or transilluminator.
Checkout procedure before operation
Before operating the Ohmeda BiliBlanket Plus High Output Phototherapy System, the
following steps should be taken to ensure that the BiliBlanket Plus High Output will
provide effective phototherapy treatment or the transilluminator delivers the proper
light. This checkout procedure assumes that you are familiar with the unit’s controls.
CAUTIONSw Lamp life is greatly reduced if the lamp or the light source is subjected to shock
or bumping, or if the unit is moved while the bulb is hot. Allow the bulb to cool
for at least ten minutes before moving the unit.
w Do not allow the fiber optic cable, pad or transilluminator to rub on sharp or
abrasive surfaces. The protective coverings may be damaged.
w Observe the following fiber optic cable and pad assembly and transilluminator
guidelines:
• If you hang the fiber optic cable and pad or transilluminator assembly for temporary storage on an IV pole, door, wall hook or similar item, do not pull the cable
when removing it for use. Carefully lift the cable free of obstructions when ready
to use it.
• Do not lay the fiber optic cable or transilluminator where it could be crushed.
• Do not place anything on the fiber optic cable or transilluminator.
Not observing the guidelines may cause excessive stress and may:
• damage the cable’s outer protective conduit,
• damage the cable’s optical fibers,
• decrease light intensity at the light pad or transilluminator.
Checkout procedure
1. Place the light source on a flat, level surface (or use the mounting slide bracket) to
locate the light source within a few feet of the treatment location.
2. Verify that the air circulation vents on the sides of the light source are unobstructed.
The air filter should be free from excessive amounts of lint.
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2/Operation
CAUTIONw Do not block the air intake or outlet.
3. Examine the power cord, fiber optic cable and transilluminator cable for obvious
signs of damage. Replace them if they are damaged.
4. Connect the power cord to the light source first and then to the line power supply.
5. Fully engage the fiber optic cable connector or transilluminator into the light source
port.
CAUTIONw Do not scratch or soil the light-input end of the connector cable. Do not put
sharp or heavy objects on the fiber optic pad, vest or connecting cable.
6. Select “|” on the power switch to turn the power on. The green power indicator light
will light.
7. Using the brightness selector switch on the front panel, select any light intensity and
ensure that light is being emitted from the pad.
8. Select “O” on the power switch to turn the power off.
WARNING
ww
w A hot surface is exposed when the fiber optic cable is disconnected from
ww
the light source port. Do not insert fingers or foreign objects into the light
source port whether the lamp is on or off.
Using the BiliBlanket Plus High Output Phototherapy System
The disposable cover is designed for use with both premature and full-term infants. The
infant lies directly on the covered pad without any method of attachment between the
pad and the infant.
WARNINGw If there is a concern about exposure to direct light from the light pad,
cover the patient’s eyes when using the BiliBlanket High Output Plus
Phototherapy System to shield them or when the BiliBlanket Plus High
Output is used in conjunction with conventional phototherapy lights. Eye
patch use with the BiliBlanket Plus High Output may not be necessary
under these conditions:
1. When using the vest.
2. When the pad is kept against the patient’s back.
3. When the patient is clothed after applying the pad to the patient’s chest
or abdomen.
The disposable vest secures the fiber-optic pad to the infant. For premature and fullterm infants who cannot tolerate having the vest secured around the midsection, the
disposable cover should be used.
The infant, along with the light pad, may be covered or wrapped in a blanket. The infant
will continue to receive effective phototherapy treatment as long as the disposablecovered, light-emitting section of the pad remains in contact with the skin.
The disposable cover should be the only material between the light-emitting side of the
pad and the infant’s skin. If the disposable cover becomes soiled, it should be replaced
with a new cover. The disposable cover should also be replaced between patients.
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