Drager Babytherm 8000 LDR User manual

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Babytherm® 8000 LDR
Warming Bed
Instructions for Use
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NOTICE
Proprietary Information
This document contains information in which Dräger claimed proprietary rights. The information may not be reproduced in whole or in part except as authorized in writing by Dräger. This information is the property of Dräger; it is provided solely for the use intended.
Repairs/Modifications
Repairs on this device shall be performed only by DrägerService, a division of North American Dräger (NAD), or its Authorized Service Centers. Information about repairs can be obtained from Dräger or Authorized Dealers. NAD or Dräger will not be responsible for injury to persons or damage to property arising directly or indirectly out of unauthorized repairs or modifications to this device. Furthermore, any unauthorized repairs or modifications void any warranty extended by Dräger.
This document is provided for your information only. It will not be exchanged or updated without request.
Trademarks
The Dräger name and logo and the name Babytherm® are registered trademarks of Dräger Medizintechnik GmbH.
© North American Dräger 1998
All rights reserved. Subject to modifications.
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Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Operator's Responsibility for Infant Safety . . . . . . . . . . . . . . . . . 1
Limitation of Liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Definitions and Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
General WARNINGS and CAUTIONS . . . . . . . . . . . . . . . . . . . . 5
Precautions During Preparation . . . . . . . . . . . . . . . . . . . . . . . . . 6
Precautions During Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Precautions During Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Precautions During Maintenance . . . . . . . . . . . . . . . . . . . . . . . . 7
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Mattress Heating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Storage of Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Installing Side Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Opening Side Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Installing Canopy (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Selecting a Mattress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Tilting the Bed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Tests of Readiness for Operation . . . . . . . . . . . . . . . . . . . . . . . . 13
Preuse Checkout Procedure . . . . . . . . . . . . . . . . . . . . . . . . . 13
General Precautions During Infant Care . . . . . . . . . . . . . . . . . 14
Heat Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Heater Safety Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Mattress Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Mattress Heater Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . 16
Mattress Heater Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Control Systems Self-Test . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Control Systems Operator Test . . . . . . . . . . . . . . . . . . . . . . 20
Heater Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Operation without Concurrent Use of a Radiant Warmer . . . . 22
Oxygen Therapy with Canopy . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Operator Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Adjusting Mattress Temperature . . . . . . . . . . . . . . . . . . . . . . . 23
Heater Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Power-Down Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Using the Canopy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Operation with Concurrent Use of a Radiant Warmer . . . . . . . 31
Cleaning/Disinfecting/Sterilizing . . . . . . . . . . . . . . . . . . . . .33
Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Cleaning and Disinfection Procedures . . . . . . . . . . . . . . . . . . . . 33
Before Next Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
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Contents
Inspection and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . .35
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Repair and Replacement of Parts . . . . . . . . . . . . . . . . . . . . 35
Preventive Maintenance Intervals . . . . . . . . . . . . . . . . . . . . 35
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36
Mattress Heater . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
Operator Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Warning - Fire Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Caution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Danger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
Ambient conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Ordering Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42
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Operator's Responsibility for Infant Safety
For correct and effective use of the product and in order to minimize hazards it is mandatory to carefully read and to observe all portions of this manual.
The design of the equipment, the accompanying literature, and the labeling on the equipment take into consideration that the purchase and use of the equipment are restricted to trained professionals, and that certain inherent characteristics of the equipment are known to the trained operator. Instructions, warnings, and caution statements are limited, therefore, largely to the specifics of the Dräger design. This publication excludes references to various hazards which are obvious to a medical professional and operator of this equipment, to the consequences of product misuse, and to potentially adverse effects in infants with abnormal conditions. Product modification or misuse can be dangerous. Dräger disclaims all liability for the consequences of product alterations or modifications, as well as for the consequences which might result from the combination of this product with other products whether supplied by Dräger or by other manufacturers if such a combination is not endorsed by Dräger.
Introduction
Introduction
The operators of the heated bassinet system must recognize their responsibility for choosing appropriate safety monitoring that supplies adequate information on equipment performance and infant condition. Infant safety may be achieved through a wide variety of different means ranging from electronic surveillance of equipment performance and infant condition to simple, direct observation of clinical signs. The responsibility for the selection of the best level of infant monitoring lies solely with the equipment user.
Limitation of Liability
Dräger's liability, whether arising out of or related to manufacture and sale of the goods, their installation, demonstration, sales representation, use, performance, or otherwise, including any liability based upon Dräger's Product Warranty, is subject to and limited to the exclusive terms and conditions as set forth, whether based upon breach of warranty or any other cause of action whatsoever, regardless of any fault attributable to Dräger and regardless of the form of action (including, without limitation, breach of warranty, negligence, strict liability, or otherwise).
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Introduction
Dräger shall not be liable for, nor shall buyer be entitled to recover any special incidental, or consequential damages or for any liability incurred by buyer to any third party in any way arising out of or relating to the goods.
Limited Warranty
All Dräger products are guaranteed to be free of defects in material and workmanship for a period of one year from date of delivery.
The following are exceptions to this warranty:
1. Defects caused by misuse, mishandling, tampering, or by modifications
THE STATED EXPRESSED WARRANTlES ARE IN
LlEU OF ALL OTHER WARRANTIES, EXPRESSED OR
IMPLIED, INCLUDING, WITHOUT LIMITATION,
WARRANTlES OF MERCHANTABILITY, FITNESS
FOR ANY PARTICULAR PURPOSE, OR
NONINFRINGEMENT.
not authorized by Dräger or its representatives are not covered.
2. All consumable and disposable products are guaranteed to be free from defects upon shipment only.
Any product which proves to be defective in workmanship or material will be replaced, credited, or repaired with Dräger holding the option. Dräger is not responsible for deterioration, wear, or abuse. In any case, Dräger will not be liable beyond the original selling price.
This warranty is rendered void and Dräger shall not be held liable for condition as resultant from:
1. Damage to the unit is incurred as a result of mishandling.
2. The customer fails to maintain the unit in a proper manner.
3. The customer uses any parts, accessories or fittings not specified or sold by Dräger.
4. Sale or service is not performed by an authorized service/dealer.
Application of this warranty is subject to the following conditions:
1. Dräger or its authorized representative must be promptly notified, in writing, upon detection of the defective material or equipment.
2. Contact Dräger Customer Service at 1-800-4DRAGER for a Return Authorization Number.
3. Defective material or equipment must be returned, shipping prepaid, to Dräger or its authorized representative.
4. Examination by Dräger or its authorized representative must confirm that the defect is covered by the terms of this warranty.
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Introduction
5. Notification in writing, of defective material or equipment must be received by Dräger or its authorized representative no later than two (2) weeks following expiration of this warranty.
The above is the sole warranty provided by Dräger. No other warranty expressed or implied is intended. Representatives of Dräger are not authorized to modify the terms of this warranty.
Dräger, Telford, PA
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Introduction
g
Definitions and Symbols
Warnings
Cautions
Notes
Terminology
A WARNING statement refers to conditions with a possibility of personal injury or death if disregarded.
A CAUTION statement designates the possibility of damage to equipment or improper operation if disregarded.
A NOTE provides additional information intended to clarify apparently contradictory or confusing situations.
Inspection examination of actual condition
Service measures to maintain specified condition
Repair measures to restore specified condition
Maintenance inspection, service, and repair, where
necessary
Preventive Maintenance
Maintenance measures at regular intervals
Typing conventions in this manual:
LED messages are printed in bold type:
Symbols
Example:
CAUTION
!
ATTENTION
SEt
:
:
Refer to accompanying documents before operatin
Consulter l es documents ci -joints avant de faire fonctionner l’appareil.
Denotes IEC601-1 type of applied part.
Protective earth symbol.
equipment.
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General WARNINGS and CAUTIONS
Warning: Strictly follow this Operator's Instruction Manual. Any use of
the product requires full understanding and strict observation of all portions of these Instructions. The equipment is only to be used for the purpose specified under "Intended Use." Observe all WARNINGS and CAUTIONS as rendered throughout this manual and on labels on the equipment.
Warning: This device is to be used only in rooms with line power
installations complying with national safety standards for hospital infant rooms. To maintain grounding integrity, connect only to a "hospital grade" receptacle. Always disconnect power before servicing.
Warning: Do not use in the presence of flammable anesthetics. Turn off
and disconnect oxygen supply when performing cleaning and service. Keep matches, lighted cigarettes, and all other sources of ignition out of the room in which the Babytherm is located. Small quantities of flammable agents, such as ethyls and alcohol, can cause a fire in connection with oxygen left in the Babytherm in the presence of ignition sources.
Introduction
Warning: Do not use cellular phones or similar wireless communication
equipment within 33 feet (10 m) of the Babytherm 8000 LDR. Wireless phones may cause malfunction in electromedical equipment.
Caution: Restriction of Distribution
: Federal Law restricts this device
to sale by or on the order of a physician.
Caution: Maintenance
your local DrägerService
: In case of malfunction of this device, contact
SM
technician or our Factory Authorized Technical Service Center. The device must be inspected by competent and factory authorized technical service representatives at regular intervals. A record must be kept on this preventive maintenance. Maintenance or repair of the Babytherm 8000 LDR shall be performed only by Dräger authorized technical service representatives.
Warning: Never operate the heated bassinet if it has suffered physical
damage or does not seem to operate properly. In this case, always refer servicing to properly trained and factory authorized service personnel.
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Introduction
Precautions During Preparation
Warning: Use of gel mattress when mattress heater is switched off will
result in infant becoming hypothermic. Use foam rubber mattress when mattress heater is not in use for extended periods (> 15 min.).
Caution: Never route infant circuits or lines over top of panels – they
may get pinched when folding up panels or when installing cover.
Precautions During Operation
Warning: To prevent infant fall, do not leave infant unattended when
any panels are down. All panels must be erect and secure during transport to prevent infant fall.
Warning: When folding up surrounding panels, take care not to pinch
infant body parts, circuits, or other items, such as sheets.
Warning: Temperature Monitoring
skin condition at regular intervals and adjust temperature setting to individual infant needs. Infant temperature must be monitored particularly carefully during phototherapy or while a radiant warmer is used in conjunction with the Babytherm heated bassinet.
Warning: Mattress Heater
mattress must be placed directly on the heated tray surface. Always take into account warm-up time of the mattress (approximately 1 hour) before placing an infant in the bassinet.
Warning: To minimize infant overheating, always consider effect of
additional heat sources, such as phototherapy lamps or radiant warmers. They increase the heat directed to the infant. Avoid direct sunlight.
Warning: Do not obstruct conductive heat transfer by placing
additional blankets or other insulating covers underneath the infant.
Warning: Set temperatures in the lower extended temperature range
only on the order of a physician. Check the infant's temperature and skin condition at regular intervals.
: When mattress heating is used, the gel
: Check the infant’s temperature and
Warning: Check the infant's temperature and skin condition at regular
intervals.
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Introduction
Warning: Always use a proper fitting thin sheet (Part No. 2M21272).
Do not fold the sheet under the gel mattress more than 3". To prevent infant fall in Trendelenberg or reverse Trendelenberg position always use proper fitting mattress sheet.
Warning: When used with an infant radiant warmer, check its
operator’s manual for directions of the correct heat level and distance to the infant.
Warning: Use of radiant warmers may increase insensible water loss.
Measures to maintain desired fluid levels should be considered.
Warning: Use of Radiant Warmer
recommended. Dräger cannot warrant or endorse the safe performance of third party radiant warmers for use with the Babytherm 8000 LDR. Specifically, combinations with radiant warmers that are not intended for use with heated bassinets bear risks of excessive overall heat transfer to the infant.
Caution: Remove from mattress all objects with sharp edges. Do not
fold gel mattress. The gel mattress may become damaged.
Precautions During Care
Warning: Always follow accepted hospital procedures for handling
equipment contaminated with body fluids.
Warning: Always disconnect AC line cord before cleaning and
disinfecting.
Caution: Do not launder mattress in an automatic washing machine.
Do not autoclave mattress.
Precautions During Maintenance
Warning: To minimize the risk of infection, clean and disinfect bassinet
and accessories before any maintenance according to established hospital procedures – this applies also when returning units or parts for repair.
: Use of the Dräger RH600 warmer is
Warning: Maintenance work on the Babytherm 8000 LDR may be
performed by trained and factory authorized staff only.
Warning: Never operate the heated bassinet if it has suffered physical
damage or does not seem to operate properly. In this case, always refer servicing to properly trained and factory authorized service personnel.
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Introduction
Intended Use
Babytherm 8000 LDR is a heated bassinet intended as a therapeutic device providing warmth, with or without the use of a canopy, for premature and full-term neonates and infants up to 16 lbs.
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Mattress Heating
The Babytherm 8000 LDR features a mattress heating system that uses conductive heat to warm up infants and to keep them warm.
The system consists of a gel mattress, a heating plate and an electronic control and monitoring unit. The gel is enclosed by a soft, skin compatible film.
The mattress molds itself to the body contours of the infant lying on it, resulting in a large contact surface, a property that helps promote thermal heat transfer to the infant and minimizes pressure points. A cold gel mattress, on the other hand, dissipates infant thermal energy. The gel material has an excellent capacity for storing heat. When the power supply is disconnected (e. g. during transport within the hospital), the infant is kept warm for approximately 15 minutes if sufficiently insulated (blanket, cover).
Description
Description
Features
The heating plate consists of an aluminum plate with a heater element attached to its under side. It distributes heat evenly over the entire bed area.
The control and monitoring unit is located under the heating plate and faces the side most frequently accessed by caregivers.
The micro-processor controlled system continuously monitors the status of the electronic temperature control and alarm system, and alerts the user if any faults are detected.
With its ergonomic design including:
foldable side panels for increased access to the infant
tilting bed for Trendelenberg and reverse Trendelenberg position
pop-up side table – integrated hand rail
cable management system
storage space in the cabinet
5 inch diameter castors, two with locks
optional canopy
it serves an important function for newborn babies from the first minute after birth until discharge to home.
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Description
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Storage of Supplies
Always observe the stated weight limits when placing items on the shelf.
Installing Side Panels
The bassinet is surrounded by two side panels and two end panels, which can be opened independently of each other. End panels have cutouts with U-grommets for routing circuits and infant cables.
Preparation
Preparation
SIDE PANEL HINGE
DI0001
Figure 1. Installation of Side Panel
1. Insert lower pins on panel hinges into the left- and right-hand slots in bassinet base.
2. Position panel semi-upright.
3. Press panel down firmly, until pins lock into position at the bottom of slots.
Tilt panel fully upright and let it drop into locking position.
4. Install all four panels in the same fashion.
5. Verify the panels are seated correctly.
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Preparation
Opening Side Panels
To open Babytherm side panels:
1. Lift panel all the way up, until upper pins on hinge brackets are out of their guide slots.
2. Fold down.
Installing Canopy (
OPTIONAL
Place canopy over side and end panels so that the flanges on the canopy interlock with the end panel cutouts.
Selecting a Mattress
1. Select mattress type:
Operation with mattress heating:
Operation without mattress heating:
2. Place the mattress in bassinet and cover it with a thin sheet.
Warning: Always use a proper fitting thin sheet (Part No. 2M21272)
)
Gel mattress (Part No. 2M20827) [
Foam rubber mattress (Part No. 2M21012) [
[
PROVIDED
]. Do not fold the sheet under the gel mattress more than 3". To prevent infant fall in Trendelenberg or reverse Trendelenberg position always use proper fitting mattress sheet.
PROVIDED
].
OPTIONAL
].
Tilting the Bed
Warning: Do not obstruct conductive heat transfer by placing
additional blankets or other insulating covers placed underneath the infant.
Warning: Use of gel mattress when mattress heater is switched off will
result in infant becoming hypothermic. Use foam rubber mattress when mattress heater is not in use for extended periods (> 15 min.).
The bed can be locked in three positions: head up, level, or feet up.
1. Pull handle of locking mechanism up.
2. Tilt the bed as desired.
Tilt angles:
Trendelenberg position: 10°
Reverse Trendelenberg position: 10°
3. Release locking handle, the bed locks into position.
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Tests of Readiness for Operation
1. Verify that supplied voltage agrees with the values indicated on the rating plate next to the power cable.
2. Inspect the power plug and power cord for signs of wear.
3. Inspect gel mattress and infant area for signs of damage.
Preparation
Preuse Checkout Procedure
Prior to each use:
1. Disinfect the Babytherm per institutional procedures.
2. Lock the side and end panels securely into place.
3. Verify that all panels are free of cracks and sharp edges.
4. Verify that the correct mattress is in the bassinet.
Operation with mattress heater
Operation without mattress heater
gel mattress,
foam rubber mattress.
5. Check the bed tilt positions and lock securely into required angle.
6. Verify that all patient lines and circuits are securely and properly installed.
Caution: Never route infant circuits or lines over top of panels – they
may get pinched when folding up panels or when installing cover.
7. Verify that the storage doors and the pop-up table are working properly.
8. Verify that the two locking casters function properly.
9. Lay gel mattress flat on the heating plate.
10. Connect plug to properly grounded, hospital grade power outlet.
11. Press button.
Check
a. all LEDs illuminate for approximately 2 seconds
b. numeric displays show
88.8
c. an audible alarm is generated
d. displays and LEDs extinguish
e. the audible alarm is silent
f. after 2 seconds, actual temperature is displayed.
Note: This function check is possible during operation without affecting
any of the settings.
12. Contact your DrägerService authorized service/dealer in case of failure.
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Preparation
General Precautions During Infant Care
Warning: To prevent infant fall, do not leave infant unattended when
any panels are down. All panels must be erect and secure during transport to prevent infant fall.
Check that all 4 panels are closed and locked securely into place.
Warning: To allow for adequate air flow while canopy is in use, do not
obstruct openings around side panels of the bassinet.
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y
The heating system provided with Babytherm 8000 LDR is a conductive mattress heater. Please refer to “Operation with Concurrent Use of a Radiant Warmer” on page 31 for information about use of Babytherm 8000 LDR in the presence of radiant warmers.
Warnings and Cautions
Heat Therapy
Heat Therap
Heater Safety Precautions
Mattress Repair
Warning: Temperature Monitoring
skin condition at regular intervals and adjust temperature setting to individual infant needs. Infant temperature must be monitored particularly carefully during phototherapy or while a radiant warmer is used in conjunction with the Babytherm heated bassinet.
Should the gel mattress become punctured or ruptured, use the Dräger mattress repair kit (Part No. 2M21324) to close the opening. In an emergency clear adhesive tape may be used to temporarily fix the mattress.
Caution: Remove from mattress all objects with sharp edges. Do not
fold gel mattress. The gel mattress may become damaged.
Warning: Mattress Heater
mattress must be placed directly on the heated tray surface. Always take into account warm-up time of the mattress (approximately 1 hour) before placing an infant in the bassinet.
Warning: To minimize infant overheating, always consider effect of
additional heat sources, such as phototherapy lamps or radiant warmers. They increase the heat directed to the infant. Avoid direct sunlight.
: When mattress heating is used, the gel
: Check the infant’s temperature and
Warning: This device is to be used only in rooms with line power
installations complying with national safety standards for hospital infant rooms. To maintain grounding integrity, connect only to a "hospital grade" receptacle. Always disconnect supply before servicing.
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Heat Therapy
Mattress Heater Control Panel
678910
°C
>37 °C <35 °C
°C
12 34 5
Legend
(1)
Button for extending range of settings to temperatures from 30° C to 38.5° C
(2)
Display of mattress set temperature
• to the left of display: button for decreasing set temperature
• to the right of display: button for increasing set temperature
(3)
Alarm silence button for silencing intermittent audible alarm for 15 minutes;
• Yellow LED in button illuminates while intermittent audible alarm is silenced
40 °C ±1 °C Inop
Babytherm 8000
Check
(6)
Display of actual (measured) mattress temperature
(7)
Red LED ; illuminates in case of power failure
(8)
Red LED 40° C; flashes when measured mattress temperature exceeds 40° C
!
DI0002
16
(4)
Button for checking function of LEDs,
(9)
displays and audible alarm
(5)
Power switch
(10)
Figure 2. Babytherm Mattress Heater Control Panel
Red LED ±1° C; flashes when measured mattress temperature deviates more than ±1° C from set value
Red LED Inop; illuminates in case of unit malfunction
Page 23
Mattress Heater Alarms
Heat Therapy
±1° C alarm Red LED ±1° C (9) flashes
actual value display flashes
intermittent audible alarm.
40° C alarm Red LED 40° C (8) flashes
actual value display flashes
continuous audible alarm.
Power failure Red LED ; (7) illuminates
continuous audible alarm.
Inoperable device
Red LED Inop (10) illuminates
Err appears on actual value display alternately with
measured value
Error code is flashing in set value display, continuous audible alarm.
Sensor alarm 3 flashing dashes >>– – –<< in the middle of the
actual value display (6)
Capacitor discharge alarm
Acc appears on actual value
display (6) alternately with measured value.
Intermittent audible alarm.
Note: Due to periods of non-use, the capacitor powering the power failure
alarm may become discharged. By turning the unit on, the backup capacitor will be charged automatically and the alarm will silence as soon as the capacitor is charged. Press alarm silence button to
silence the Acc alarm until the capacitor is charged.
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Heat Therapy
Control Systems Self-Test
°C
40 °C ±1 °C Inop
Babytherm 8000
>37 °C <35 °C
DI0003
Figure 3. Babytherm Power On and Self-Test
Check
Switching heater unit on activates the Babytherm systems self-test:
1. Press power switch until it engages = ON.
a. A microprocessor self-test now checks proper function of the unit
including all temperature sensors, power relays, AC and DC supply voltages and microprocessor watchdogs.
all LEDs
the numeric display shows
illuminate
88.8
an audible alarm is generated.
b. After approximately 2 seconds, the unit shows the default set
temperature of 37.0° C (display blinking).
!
POWER
SWITCH
18
40 °C ±1 °C
°C
>37 °C <35 °C
Figure 4. Setting Babytherm Temperature Control
Inop
Babytherm 8000
Check
c. The display alternates between SEt = "Set value" and measured
temperature.
2. Press down [
R]
or up [P] button to accept the default value as set value.
Display now shows the measured mattress temperature continuously.
!
Page 25
Power Failure
ging
Alarm Backup Rechar
Heat Therapy
40 °C ±1 °C
°C
Inop
Babytherm 8000
Failure of Self-Test
>37 °C <35 °C
Check
!
DI0005
Figure 5. Insufficient Charge for Power Failure Alarm
The display may alternate between measured temperature with a simultaneous intermittent audible alarm. This means that the power failure alarm backup capacitor is not sufficiently charged.
1. Continue operation. After approximately 30 minutes, the backup capacitor will be fully charged. The display will then show the measured temperature continuously without an audible alarm.
To silence the audible alarm:
2. Press alarm silence button , its yellow LED will illuminate.
An intermittent audible alarm can be silenced for 15 minutes.
°C
= "rechargeable backup" and
Acc
40 °C ±1 °C Inop
Babytherm 8000
>37 °C <35 °C
Check
!
Figure 6. Control Panel Shows Failure of Self-Test
The display may alternate between Inop LED illuminates. The unit is inoperative: see “Troubleshooting” on page 36 or consult qualified service personnel.
and measured temperature, and red
Err
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Heat Therapy
Control Systems Operator Test
Control Panel Checkout
40 °C ±1 °C
°C
Inop
Babytherm 8000
>37 °C <35 °C
Figure 7. Operator Checkout of Control Systems
Check
In order to check LEDs, displays and audible alarm:
1. Press button.
Check
a. all LEDs illuminate for approximately 2 seconds
b. numeric displays show 88.8
c. an audible alarm is generated
d. displays and LEDs extinguish
e. the audible alarm is silent
f. after 2 seconds, actual temperature is displayed.
Note: This function check is possible during operation without affecting
any of the settings.
2. Perform control systems check at least once daily.
!
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Page 27
Power Failure Alarm Checkout
°C
40 °C ±1 °C Inop
Heat Therapy
Babytherm 8000
Figure 8. Operator Checkout of Power Failure Alarm
To check power failure alarm:
1. Remove power plug from outlet.
2. Reconnect power plug.
Heater Operation
1. Set temperature to 38° C during warm-up. Allow approximately 1 hour
>37 °C <35 °C
Check
!
DI0008
Red LED illuminates and continuous audible alarm is generated.
Red LED extinguishes. Audible alarm is silenced. Unit continues to operate with temperature values set prior to power failure.
for thorough warm-up. During warm-up and in standby mode, cover the gel mattress with a thick blanket to minimize heat loss to the environment.
2. Remove the thick blanket and place the infant on the gel mattress (now only covered with a thin sheet).
3. Set mattress temperature according to infant’s needs and ambient conditions.
4. Monitor baby’s temperature and adjust mattress temperature as needed. Allow time for the heated gel mattress to react to any changes to the temperature set point.
Caution: Always use a thin sheet to cover the mattress.
Warning: Do not obstruct conductive heat transfer by placing
additional blankets or other insulating covers underneath the infant.
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Heat Therapy
Operation without Concurrent Use of a Radiant Warmer
Figure 9. Babytherm Operation without Radiant Warmer or Canopy
When no radiant warmer is used:
DI0009
1. Cover infant with a blanket.
Warning: Use of gel mattress when mattress heater is switched off will
result in infant becoming hypothermic. Use foam rubber mattress when mattress heater is not in use for extended periods (> 15 min.).
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Oxygen Therapy with Canopy
Heat Therapy
Operator Precautions
An oxygen analyzer should be used when oxygen is administered. The following table illustrates approximate oxygen concentrations with the indicated flows.
Flow Approximate
Concentration
5 L/min O
2
30% O
10 L/min O240% O
15 L/min O250% O
Adjusting Mattress Temperature
°C
>37 °C <35 °C
2
2
2
40 °C ±1 °C Inop
Check
Babytherm 8000
!
DI0010
Figure 10. Adjusting Temperature Within Normal Range
Temperature can be varied in steps of 0.1 degree Celsius.
Setting the temperature in the normal range (35° C to 37° C):
1. Press and hold the down [R]or up [P]button until desired temperature is displayed.
>37 °C <35 °C
40 °C ±1 °C
°C
Inop
Check
Babytherm 8000
!
DI0011
Figure 11. Adjusting Temperature in Extended Range
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Heat Therapy
Setting temperature in extended range:
extended lower range: 30° C to 35° C,
extended upper range: 37° C to 38.5° C.
2. Press the extended range button.
The yellow LED in the button is illuminated.
3. Within 1 minute, input a temperature above 37° C or below 35° C.
Hold the down [R]or up [P]button until desired temperature is
showing on the display.
If there is a delay between pressing the extended range button and entering the temperature value, the LED in the extended range button will extinguish and the extended temperature ranges will be locked again.
Note: A change of more than 1° C in the settings will trip the
temperature deviation alarm. Press the alarm silence button to silence the audible alarm. The display will flash until the temperature is within 1° C of the set temperature.
°C
°C
Figure 12. Control Panel Showing Temperature in Extended Range
When the temperature is outside a range from 5° C to 45° C:
three dashes in the bottom of the display =
the temperature is below 5° C
three dashes in the top of the display =
the temperature is above 45° C.
Note: This may occur, e. g., when the Babytherm 8000 LDR is stored in
ambient conditions beyond the range of 5° to 45° C.
DI0012
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Heater Alarms
Heat Therapy
40 °C ±1 °C
°C
Inop
Babytherm 8000
>37 °C <35 °C
Check
!
DI0013
Figure 13. Control Panel Showing Set Temperature Alarm Condition
Deviation from set temperature:
In case of deviations greater than ±1° C between actual and set mattress temperature:
red LED ±1° C flashes
an intermittent audible alarm is generated
the display flashes.
The intermittent audible alarm can be silenced for approximately 15 minutes:
1. Press the alarm silence button , its yellow LED will illuminate.
The red LED ±1° C remains illuminated.
When the actual mattress temperature has returned to a value within ±1° C of the set temperature:
All visual and audible alarms are reset.
After the mattress heater is initially switched on:
audible alarm is silenced for 1 hour (warm-up)
red LED ±1° C is illuminated
yellow LED in the
button is illuminated.
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Heat Therapy
Power-Down Procedure
40 °C ±1 °C
°C
>37 °C <35 °C
DI0014
Figure 14. Control Panel Showing High Temperature Alarm Condition
Inop
Check
Babytherm 8000
40° C alarm:
In case of high temperature:
red LED 40° C flashes
a continuous audible alarm sounds.
the display flashes.
Note: The continuous alarm cannot be manually silenced. The alarm
resets automatically when the temperature decreases below
.
40° C
This procedure applies only for equipment processing between uses.
1. Press the power switch on the front panel.
!
26
All displays will be extinguished.
2. Disconnect power plug from outlet.
3. Store the power cord using the cable holder on the unit.
Page 33
Using the Canopy
Extreme care must me taken when using the canopy accessory (Part No. 2M21030) together with an infant radiant warmer. The radiant energy from the overhead radiant warmer will be absorbed by the canopy. The infant will not receive direct radiant energy from the radiant warmer, but a much lower indirect radiation from the warm canopy.
The use of the canopy may be desired with stable infants. When warming a cool infant, the use of the canopy will result in a much longer heat-up time.
Heat Therapy
Warning: To prevent possible injury to operator or patient, do not use
radiant warmer while canopy is in use.
The maximum measured CO2 concentration with the canopy in place
is 0.1%, when measured in accordance with IEC 601-2-19, subclause 105.
Always use a foam rubber mattress (Part No. 2M21012).
Do not use a gel mattress without mattress heating, or when mattress
heating is switched off.
Warning: Temperature Monitoring
skin condition at regular intervals and adjust temperature setting to individual infant needs. Infant temperature must be monitored particularly carefully during phototherapy or while a radiant warmer is used in conjunction with the Babytherm 8000 LDR heated bassinet.
: Check the infant’s temperature and
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Page 34
Heat Therapy
36.3°C
38.0°C
Figure 15. Babytherm Operation with Radiant Warmer and Mattress Heating
Using radiant warmers and mattress heating with a gel mattress:
To add warmth from below, in addition to a radiant warmer.
1. Set mattress heater temperature to, e. g., 38° C.
2. Set skin temperature at the radiant warmer to the desired skin temperature of the infant.
Warning: Use of gel mattress when mattress heater is switched off will
result in infant becoming hypothermic. Use foam rubber mattress when mattress heater is not in use for extended periods (> 15 min.).
DI0015
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36.3°C
Heat Therapy
37.0°C
Figure 16. Babytherm Operation for Neutral Balance
To achieve a neutral balance:
1. Set mattress heater temperature to, e.g., 37° C.
2. Set skin temperature at the radiant warmer to the desired skin temperature of the infant.
DI0016
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Heat Therapy
36.3°C
36.0°C
DI0017
Figure 17. Babytherm Operation to Cool Infant
To cool the infant from below:
1. Set mattress heater temperature to, e.g, 36° C.
2. Set skin temperature at the radiant warmer at the desired skin temperature of the infant.
Note: Always consider the effect of the two independent heat
sources: The overhead radiant warmer and the heated gel mattress.
Warming and cooling down an infant can be achieved with different settings of both warmers. Always choose the appropriate settings with regards to the infant’s needs and the ambient conditions.
An overhead radiant warmer will supply a large amount of energy quickly. The radiant warmer energy can be controlled by the infant’s skin temperature via a skin temperature sensor.
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The heated gel mattress provides additional heat (or cooling) depending on the settings relative to the infant’s temperature. The heated gel mattress will provide gentle, conductive heat at lower level with slower increase (or decrease) compared to an infant radiant warmer.
The heated gel mattress will significantly reduce the time to heat up an infant compared to an infant radiant warmer alone.
Operation with Concurrent Use of a Radiant Warmer
Heat Therapy
Warning: Use of Radiant Warmer
Dräger RH600 warmer. Dräger cannot warrant or endorse the safe performance of third party radiant warmers for use with the Babytherm 8000 LDR. Specifically, combinations with radiant warmers that are not intended for use with heated bassinets bear risks of excessive overall heat transfer to the infant.
Warning: Temperature Monitoring
skin condition at regular intervals and adjust temperature setting to individual infant needs. Infant temperature must be monitored particularly carefully during phototherapy or while a radiant warmer is used in conjunction with the Babytherm 8000 LDR heated bassinet.
Warning: To minimize infant overheating, always consider effect of
additional heat sources, such as phototherapy lamps or radiant warmers. They increase the heat directed to the infant. Avoid direct sunlight.
Warning: When used with an infant radiant warmer check its operators
manual for directions of the correct heat level and distance to the infant.
Warning: Use of radiant warmers may increase insensible water loss.
Measures to maintain desired fluid levels should be considered.
: Dräger recommends the use of the
: Check the infant’s temperature and
Warning: To prevent possible injury to operator or patient, do not use
radiant warmer while canopy is in use.
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Heat Therapy
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Care
Cleaning/Disinfecting/Sterilizin
Cleaning/Disinfecting/Sterilizin
The Babytherm 8000 LDR heated bassinet must be thoroughly cleaned and disinfected after each infant. Perform any disinfection procedures according to established hospital procedures as well as to the following additional instruction.
Warning: Always follow accepted hospital procedures for handling
equipment contaminated with body fluids.
Before any cleaning procedures, the bassinet must first be partially disassembled. For the cleaning and disinfecting of accessories, see their respective Operating Instructions.
Disassembly
1. Switch off the Babytherm warming bed.
2. Disconnect power cord from AC receptacle.
Warning: Always disconnect AC line cord before cleaning and
disinfecting.
3. Remove any ancillary infant care equipment from unit.
4. Remove mattress from bassinet.
5. Store the mattress flat; do not fold or roll.
Caution: Remove all sharp objects from mattress. Do not fold gel
mattress. The gel mattress may become damaged.
Cleaning and Disinfection Procedures
To prevent any damage, we recommend using only detergents and disinfectants compatible with the materials used in the bassinet and its components and accessories. Use aldehydes, or quarternary ammonium compounds according to manufacturer’s label and established hospital disinfection procedures.
Always follow the instruction labels specifically with respect to prescribed concentrations and the necessary exposure times.
Warning: To minimize any risk of infection, clean and disinfect bassinet
and accessories before any maintenance according to established hospital procedures – this also applies when returning units or parts for repair.
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Page 40
Cleaning/Disinfecting/Sterilizin
g
Caution: Do not use alcohol on the side and end panels; it will damage
materials.
Caution: Do not launder mattress in an automatic washing machine.
Do not autoclave mattress.
1. Follow manufacturer’s instructions for use of the cleaning/disinfection detergent for effective wipe-disinfection.
2. Wipe-disinfect the following surfaces:
side and end panels, inside and outside
resting surface
acrylic canopy
gel mattress (foam rubber mattress)
wooden bassinet, including attachments.
3. Remove visible impurities with a cloth and detergent.
4. Wipe with a damp cloth.
5. Dry with a clean cloth.
Before Next Use
1. Reassemble components.
2. Operate unit for a few hours without an infant, in order to eliminate any
3. Check the wood surface for sharp nicks. Any sharp nicks on the surface
Before an infant is placed in the Babytherm 8000 LDR:
4. Set up accessories for therapy as needed.
5. Check readiness for operation. See “Tests of Readiness for Operation” on
6. Verify that mattress is sufficiently preheated.
disinfectant residues from prior disinfection (at mattress temperature setting of 37° C).
of the wood bassinet need to be repaired by authorized service personnel.
page 13.
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Inspection and Maintenance
Inspection and Maintenance
Precautions
Repair and Replacement of Parts
Preventive Maintenance Intervals
Warning: To minimize any risk of infection, clean and disinfect bassinet
and accessories before any maintenance according to established hospital procedures – this applies also when returning units or parts for repair.
Warning: Always disconnect power before servicing.
Warning: Never operate the heated bassinet if it has been damaged or
does not seem to operate properly. In this case always refer servicing to properly trained and factory authorized service personnel.
Gel mattress For damage to the gel mattress use the
Dräger repair kit (Part No. 2M21324).
Grommets Replace broken or lost grommets.
The Accreditation Manual for hospitals requires each piece of equipment to be tested prior to initial use and at least annually thereafter. To comply with this standard, it is recommended that you participate in our Periodic Manufacturer’s Service Program. This service can be performed by authorized DrägerService technicians.
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Troubleshootin
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ging
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Troubleshootin
Mattress Heater
Problem/Message Likely Causes Remedy
Red LED ±1° C flashes, actual value display flashes, intermittent audible alarm
Red LED 40° C flashes, actual value display flashes, continuous audible alarm.
Red LED illuminated, continuous audible alarm.
Red LED Inop illuminates , actual value display alternately with measured value. Error code is flashin continuous audible alarm.
3 flashin of the actual value display.
Acc
alternately with measured value. Intermittent audible alarm. See “Power Failure Alarm Backup Rechar pa
dashes >> - - - << in the middle
appears on actual value display
e 19.
Err
appears on
in set value display,
” on
Measured mattress temperature deviates from set t emperature by more than ±1° C.
Mattress temperature >40° C Durin
No electrical power Check power connection .
Device malfunction
Failed temperature sensors
Backup capacitor for power failure al arm is not char sufficiently.
ed
operation with radiant
Durin warmer: reduce radiant warmer output.
operation with radiant warmer: reduce radiant warmer output.
Call DrägerServiceSM. Call Drä
Call Drä
Operate device for 30 minutes, Press button [Alarm Silence], audible alarm will be silenced for 15 minutes.
erServiceSM.
erServiceSM.
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Page 43
Operator Precautions
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OPERATOR PRECAUTIONS PRÉCAUTIONS À PRENDRE
Precautions
Precautions
Warning ­Fire Hazard
1. Do not switch off heater while infant is lying on the gel mattress as this may lead to accidental hypothermia.
2. Use foam mattress when heater is to remain switched off.
3. When used with a radiant warmer, check its operator’s manual for directions on correct heat level and distance to infant.
4. Check infant's temperature and skin condition at re temperature settin
5. An oxy when oxy
Flow approximate
5 L/min O 10 L/min O2 40% O 15 L/min O
WARNING - FIRE HAZARD! ATTENTION - RISQUE D’INCENDIE!
30% O
2
2
ular intervals and adjust
to infant's needs.
en analyzer should be used
en is administered.
concentration
2 2
50% O
2
1. Risque d'hypothermie. Ne pas arrêter le chauffa matelas-
2. Utiliser un matelas ca outchouc-mousse lors d'un arrêt de longue durée du chauffa
3. Lors de l'utilisation de chauff a radiant, utiliser la notice d'utilisation pour le reglage approprié de température et dista nce e n fonct ion des besoins du patient.
4. Surveillier ré et l'état de la peau du nourisson et régler le chauffage en fonction des besoins de patient.
5. Lors de l'administration en oxy utiliser un analyseur d'oxy
Débit recommandé pour concentration
5 L/min O 10 L/min O 15 L/min O
e lors de l'utilisation d'un
el.
e.
ulièrement la températu re
approximative
2
2 2
30% O 40% O 50% O
e
ène.
2 2 2
ène,
Keep matches, li other sources of i Babytherm 8000 LDR is located.
hted cigarettes and all
nition out of room where
Garder toute source d'alluma (ex: allumettes, ci flammes) hors de la chambre des lits chauffés stationnés.
arettes, étincelles et
e
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Caution
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Precautions
CAUTION! ATTENTION!
Danger
Warning
To maintain to a properly wired "hospital receptacle.
To reduce risk of electric shock, do not remove controller cover.
Federal (USA) law restricts this device to sale by or on the order of a physician.
DANGER! DANGER! Risk of explosion if used in the presence of
flammable anesthetics.
WARNING! ATTENTION!
1. To allow for adequate air flow while canopy is in use, do not obstruct openin bassinet.
2. T o pre vent poss ible in jury to op erator or patient, do not use radiant warmer while canopy is in use.
3. Disconnect power before servicin
4. To reduce risk of electric shock, do not remove cover.
5. Repairs on this equipment to be performed only by Drä
its authorized servic e centers.
rounding integrity , connect onl y
rade"
s around side panels of the
.
erService
SM
or
Pour assurer une mise à la terre approprié n'utiliser que les prises murales conforme aux exi
Pour éviter tous risques d'électrocution ne pas enelever le ou les panneaux de protections.
Risque d'explosion à proximité d'a anesthésiques inflammable.
1. Ne pas obstruer les trous d’aération
2. Pour éviter tous risques d’incident de
3. Débrancher l'appareil avant toute
4. Pour éviter tous risques d’électrocution
5. Les réparations et révisions de
ences de l'hôpital.
lorsque le couvercle est placé.
l’utilisateur ou du patient, ne pas mettre le chauffa le couvercle est placé.
intervention.
ne pas enlever le ou les panneaux de protections.
l'appareil doivent être confiées uniquement au Drä
personnel autorisé par le DrägerService.
ents
e radiant en marche lorsque
erServiceSM ou
38
Page 45
Ambient conditions
Technical Data
Technical Data
Operation
Storage
Electrical
Temperature . . . . . . . . . . . . . . . . . . . . 20° C to 30° C (68° F to 86° F)
Relative humidity . . . . . . . . . . . . . . . . . . . . .0 to 90%, noncondensing
Temperature . . . . . . . . . . . . . . . . . . . –20° C to 60° C (-4° F to 140° F)
Relative humidity . . . . . . . . . . . . . . . . . . . . .0 to 90%, noncondensing
Electrical Safety Standard . . . . . . . . . . . . . . . IEC 601-1, UL 2601-1,
. . . . . . . . . . . . . . . . . . . . . . . CAN/CSA-22.2 No. 601.1-M90, NRTL/C
Equipment Class . . . . . . . . . . . . . . . . . . . . . . . .Class I, Type B, IPX-0
Heating surface of mattress . . . . . . . . . . . . . . . . . . . . . . . . . . Type BF
RFI suppression . . .complies with EN 55011, 1991/EN 55014, 1993;
. . . . . . . . . . . . . . . . . . . . . . VfG 293/1991; and Directive 89/336/EEC
Fuses . . . . . . . . . . . . . . . . . . . . . T 1.6 A L 250 V; IEC 127-2/III (two)
Input voltage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120V @ 50-60 Hz
Input current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.4 amps
Power consumption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160 W
Temperature
Measurement range . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5° C to 45° C
Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ±0.5° C
Setting range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30° C to 38.5° C
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Technical Data
Dimensions
Length x Width . . . . . . . . . . . . . . . 940 x 620 mm (37.0 x 24.4 inches)
Total height (with cover) basic unit . . . . . . . . . 1245 mm (49 inches)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .or 1321 mm (52 inches)
Working height of the bed surface . . . . . . . . . . . . 914 mm (36 inches)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .or 991 mm (39 inches)
bed size . . . . . . . . . . . . . . . . . . . . . 750 x 490 mm (29.5 x 19.3 inches)
Mattress position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ±10° from level
Height of side and end panels . . . . . . . . . . . . . . 150 mm (5.9 inches)
Weight (with cabinet and canopy) basic unit . . . . . . . 85 kg (187 lbs)
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Ordering Information
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Ordering Information
Name and Description Part No. Name and Description Part No.
Babytherm 8000 LDR (36-inch or 39-inch height)
Option Set of side panels,
hei
ht 150 mm
yellow
white
Canopy 2M21030 Documentation on request
4114635 Foam rubber mattress
for unheated bassinet Gel mattress
for use with mattress heater Mattress sheet Silicone U­Mattress Repair Kit
Power cord, 15-foot 4109600
2M21032 2M30242
Service Manual
rommet
2M21012
2M20827
2M21272 2M20434 2M21324
41
Page 48
Notes
Notes
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Page 50
Manufactured by: North American Dräger 3135 Quarry Road Telford, PA 18969 (215) 721-5400 (215) 721-9561 (Sales Fax) (215) 723-5935 (Service Fax)
Distributed by: Dräger, Inc. 3135 Quarry Road Telford, PA 18969
Part Number: 4114750-001 (Babytherm® 8000 LDR Instructions for Use) Rev: -
Date:May 30, 1998 © 1998 N.A.D., Inc. Subject to modifications
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