Drager Babytherm 8000 WB User manual

Page 1
Babytherm 8000 WB
Heated Bassinet
Operating Instructions
Operating Instructions Babytherm 8000 WB
1-214-94
Page 2
Proprietary Information
This document contains information in which Dräger, Inc. 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, Inc., it is provided solely for the use intended.
Repairs/Modifications
Repairs on this device shall be performed only by DrägerService or its Authorized Service Centers. Information about repairs can be obtained from Dräger or Authorized Dealers. Dräger, Inc. 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 Drägerwerk Aktiengesellschaft.
Dräger, Inc. 1994 All rights reserved, Subject to modifications
Operating Instructions Babytherm 8000 WB
Page 3
Contents
Contents
Page
Introduction READ THIS FIRST............................ 4
Operator's Responsibility for Patient Safety....... 4
Limitation of Liability.......................................... 4
Warranty........................................................... 5
Definitions......................................................... 6
General WARNINGS and CAUTIONS.............. 7
Precautions During Preparation......................... 8
Precautions During Operation ...........................8
Precautions During Care................................. 10
Precautions During Maintenance...........................10
Intended Use.......................................................11
Description.......................................................... 11
Preparation..........................................................12
Adjusting the Height ....................................... 12
Storage of Supplies ........................................12
Attaching Infusion Bottle Holder.......................12
Installing Surrounding Panels ..........................13
Fitting a Mattress ............................................14
Tilting the Bed ................................................ 15
Tests of Readiness for Operation ...................... 16
General Precautions During Patient Care ..........17
Page
Care ....................................................................30
Disassembly.................................................... 30
Cleaning/Disinfecting/Sterilizing.......................31
Before Next Use ............................................ 31
Inspection and Maintenance............................... 32
Replacement of Parts...................................... 32
Preventive Maintenance Intervals..................... 32
Troubleshooting.................................................. 33
Mattress Heater...............................................33
Electric Height Adjustment (Option).................33
What's What........................................................ 34
Overview......................................................... 34
Mattress Heater Control Panel.........................35
Labels.............................................................36
Technical Data.....................................................38
Ordering Information...........................................40
Index ...................................................................41
Notes .................................................................. 42
Heat Therapy ..................................................... 17
Heater Safety Precautions ............................. 17
Mattress Heating ........................................... 17
Checking Heater Readiness for Operation.......18
Heater Operation ........................................... 22
Alarms ........................................................... 24
Shut-Down .................................................... 24
Notes on Mattress Heater Settings ................ 25
Operation with Concurrent Use of a
Radiant Heater .............................................. 26
Taking X-Rays .................................................... 29
Operating Instructions Babytherm 8000 WB
3
Page 4
Introduction Operator's Responsibility for Patient Safety
Limitation of Liability
Introduction
Operator's Responsibility for Patient Safety
For correct and effective use of the product and in order to avoid 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 patients with abnormal conditions. Product modification or misuse can be dangerous. Dräger, Inc. 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, Inc..
Limitation of Liability
Dräger, Inc.'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, Inc.'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, Inc. and regardless of the form of action (including, without limitation, breach of warranty, negligence, strict liability, or otherwise).
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.
Dräger, Inc. 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.
The operators of the heated bassinet system must recognize their responsibility for choosing appropriate safety monitoring that supplies adequate information on equipment performance and patient condition. Patient safety may be achieved through a wide variety of different means ranging from electronic surveillance of equipment performance and patient condition to simple, direct observation of clinical signs. The responsibility for the selection of the best level of patient monitoring lies solely with the equipment operator.
4
Operating Instructions Babytherm 8000 WB
Page 5
Warranty
Warranty
Introduction
All Dräger products are guaranteed to be free of defects for a period of one year from date of delivery. The following are exceptions to this warranty:
1. The defect shall be a result of workmanship or material. Defects caused by misuse, mishandling, tampering, or by modifications not authorized by Dräger, Inc. or its representatives are not covered.
2. Rubber and plastic components and materials are warranted to be free of defects at time of delivery.
Any product which proves to be defective in workman­ship or material will be replaced, credited, or repaired with Dräger, Inc. holding the option. Dräger, Inc. is not responsible for deterioration, wear, or abuse. In any case, Dräger, Inc. will not be liable beyond the original selling price.
Application of this warranty is subject to the following conditions:
1. Dräger, Inc. or its authorized representative must be promptly notified, in writing, upon detection of the defective material or equipment.
2. Defective material or equipment must be returned, shipping prepaid, to Dräger or its authorized representative.
3. Examination by Dräger or its authorized representative must confirm that the defect is covered by the terms of this warranty.
4. 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.
In order to assure complete protection under this warranty, the Customer Registration Card and/or Periodic Manufacturer's Service Record (if applicable) must be returned to Dräger within ten (10) days of receipt of the equipment.
Operating Instructions Babytherm 8000 WB
The above is the sole warranty provided by Dräger, Inc. No other warranty expressed or implied is intended. Representatives of Dräger are not authorized to modify the terms of this warranty.
Dräger, Inc., Chantilly, VA
5
Page 6
Introduction Definitions
Definitions
WARNING !
A WARNING statement refers to conditions with a possibility of personal injury if disregarded.
CAUTION !
A CAUTION statement designates the possibility of damage to equipment if disregarded.
NOTE: A NOTE provides additional information intended to avoid inconveniences during operation.
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 measures at regular Maintenance intervals
Typing conventions in this manual
LED messages are printed in bold type, e. g:
SEt
Operating Instructions Babytherm 8000 WB
6
Page 7
General WARNINGS and CAUTIONS
General WARNINGS and CAUTIONS
Introduction
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" (see page 11). 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 patient rooms. (e. g., IEC 601.1, "Safety of Medical Equipment).
To maintain grounding integrity, connect only to a "hospital grade" receptacle. Always disconnect supply before servicing.
WARNING !
DANGER, risk of explosion if used in the presence of flammable anesthetics.
This device is neither approved nor certified for use in areas where combustible or explosive gas mixtures are likely.
CAUTION !
Restriction of Distribution
Federal Law and Regulations in the United States and Canada restrict this device to sale by or on the order of a physician.
CAUTION !
Maintenance
In case of malfunction of this device, contact your local DrägerService or our Factory Authorized Technical Service Center.
The device must be inspected and serviced (preventive maintenance) by competent and factory authorized technical service representatives at regular 2 year intervals. A record must be kept on this preventive maintenance. We recommend obtaining a service contract through your vendor.
Maintenance or repair of the Babytherm 8000 WB shall be performed only by Dräger authorized technical service representatives.
WARNING !
Do not use cellular phones within 33 feet (10 m ) of the equipment.
Wireless phones may cause malfunction in electromedical equipment.
Operating Instructions Babytherm 8000 WB
7
Page 8
Introduction Precautions During
Preparation
Precautions During
Operation
Precautions During Preparation
WARNING !
Always select correct mattress type for intended mode of operation (see page 14)
CAUTION !
Do not place any objects above or underneath bassinet where they might be damaged when height adjustments are made.
CAUTION !
Never route patient circuits or lines over top of panels – they may get pinched when folding up panels or when installing cover.
Precautions During Operation
WARNING !
Never leave patient unattended when surrounding panels are down. Risk of patient injury by infant falling out of the bassinet.
WARNING !
When folding up surrounding panels, take care not to pinch patient body parts, circuits, or other items, such as sheets.
WARNING !
Patient Temperature Monitoring
Check the baby´s core temperature and skin condition at regular intervals and adjust temperature setting to individual patient needs.
Core temperature of the baby must be monitored particularly carefully during phototherapy or while a radiant warmer is used in conjunction with the Babytherm heated bassinet (see pages 26 - 28).
Skin temperature monitoring is no substitute for core temperature checks since the two parameters do not always closely correlate.
WARNING !
Mattress Heater
When mattress heating is used, the gel mattress must be placed directly on the heated tray surface.
The Dräger gel mattress (part no. 2M 20 827) must not be used in any bassinets other than the Babytherm 8000 WB. Heater plate temperatures
above 40 °C (104 °F) implicate the danger of
patient burns! Use of a gel mattress with unheated bassinets will result in patient cooling.
Always take into acount warm-up time of the mattress (approximately 1 hour) before placing a patient in the bassinet.
Do not switch off mattress heater while a baby is lying on the gel mattress as this will result in cooling patient .
Operating Instructions Babytherm 8000 WB
8
Page 9
Precautions During Operation (cont'd)
Introduction
WARNING !
Do not switch off mattress heater while a baby is lying on the gel mattress as this will result in cooling patient .
WARNING !
Use foam rubber mattress when the mattress heater is switched off. Gel mattress will cool the infant if mattress is switched off.
WARNING !
Do not obstruct conductive heat transfer by blankets or other insulating covers placed underneath the patient.
WARNING !
Set temperatures in the lower extended temperature range only on the order of a physician. Check the baby's temperature and skin condition at regular intervals
WARNING !
Dräger, Inc. cannot warrant or endorse the safe performance of third party radiant heaters for use with the Babytherm 8000 WB. Specifically, combinations with radiant warmers that are not intended for use with heated bassinets bear risks of excessive overall heat transfer to the pa­tient.
We recommend contacting the manufacturers/ distributors of third party radiant heater units regarding compliance of their product with heated bassinets before attempting to use them in conjunction with the Babytherm 8000 WB.
The following notes on settings of Babytherm 8000 in the presence of radiant heaters are intended as guidelines only and cannot take into consideration the specifics of individual radiant heater designs.
WARNING !
When used with an infant radiant warmer check its operators manual for directions of the correct heat level and distance to the baby.
WARNING !
Check the baby's temperature and skin
condition at regular intervals
Operating Instructions Babytherm 8000 WB
CAUTION !
Remove from mattress all objects with sharp edges. The gel mattress could be damaged!
Do not fold gel mattress!
CAUTION !
Do not place any objects above or underneath bassinet where they might be damaged when height adjustments are made.
9
Page 10
Introduction Precautions During Care
Precautions During
Maintenance
Precautions During Care
WARNING !
Always follow accepted hospital procedures for handling equipment contaminated with body fluids.
WARNING !
Always disconnect power supply before cleaning and disinfecting.
CAUTION !
Do not expose Babytherm 8000 WB to high level of ultraviolet radiation. It may cause cracks in the PMMA (perspex) parts.
CAUTION !
Certain components of the bassinet consist of ma­terials that are sensitive to certain organic solvents sometimes used for cleaning and disinfecting (e. g., alcohols, phenols, halogen releasing com-pounds, oxygen releasing compounds, strong organic acids, etc.). Exposure to such substances may cause damage that is not always immediately recognized. Sterilization of the bassinet itself with ethylene oxide (EtO) is also not recommended.
Precautions During Maintenance
WARNING !
To avoid 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 !
Preventive Maintenance work on the Babytherm 8000 WB may be performed by trained and factory authorized staff only.
WARNING !
Always disconnect supply before servicing.
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.
CAUTION !
Do not launder mattresses in an automatic washing machine. Do not autoclave mattresses
10
Operating Instructions Babytherm 8000 WB
Page 11
Intended Use
Description
Intended Use
Babytherm 8000 WB is a heated bassinet intended as a therapeutic device providing warmth for premature and full-term neonates and infants with a weight up to 16 lbs.
Description
Mattress heating
The Babytherm 8000 WB features a mattress heating system that uses conductive heat transfer to warm up patients and to keep them warm.The system consists of a gel mattress, an aluminum heating plate and an electronic control and monitoring unit.
The gel mattress consists of a gel material with excellent heat conducting properties, which won't dislocate even when the bed is tilted. The gel is enclosed by a soft, skin compatible film.
The mattress molds itself to the body contours of the patient lying on it, resulting in a large contact surface, a property that helps conducting heat to the patient and avoids pressure points (anti-decubitus effect). A cold gel mattress, on the other hand, dissipates patient thermal energy. The gel material has an excellent capacity for storing heat. When the power supply is disconnected (e. g. during a transport within the hospital), the patient is kept warm for approximately 15 minutes if sufficiently insulated (blanket, cover).
The aluminum heating plate consists of a 6 mm (1/4 inch) thick aluminum plate and a heater element attached below. It distributes heat evenly over the entire bed area.
Operating Instructions Babytherm 8000 WB
The control and monitoring unit is located under the heating plate. The membrane keypad with its buttons and displays faces the side most frequently accessed by caregivers. Temperature is set by the user and adjusts in such a way that the set temperature is just reached in those areas where the patient contacts the mattress. System monitoring includes check routines and alarm features.
Features
With its ergonomic design including: – foldable side panels for easy care.
– a tilting bed for Trendelenburg and
Reverse Trendelenburg position and options such as: – electric height adjustment
– swivel cabinet – infusion bottle holder
it serves an important function during a patient's transition from incubator to standard (unheated) bassinet.
11
Page 12
Preparation Adjusting the Height
Storage of Supplies
Attaching Infusion Bottle Holder
Preparation
Adjusting the Height (Option)
Before operating the Babytherm 8000 WB, always check electric height adjustment:
Connect power supply.
WARNING !
To maintain grounding integrity, connect only to a "hospital grade" receptacle.
1 Depress right pedal.
The bassinet is raised.
2 Depress left pedal.
The bassinet is lowered.
Adjust to comfortable working height.
CAUTION !
Do not place any objects above or underneath bassinet where they might be damaged when height adjustments are made.
Storage of Supplies
Units with electric height adjustment: – swivel cabinet (option) with 2 compartments and
1 swivel tray
Units without electric height adjustment: – 2 open compartments in the column (standard), – 1 swivel cabinet (option) with 2 compartments and
1 swivel tray.
Attaching Infusion Bottle Holder
1 2
21
Operating Instructions Babytherm 8000 WB
Mount bottle holder to side rail. Secure rail clamp.
12
Page 13
Installing Surrounding Panels Installing Inside Panels
Installing Surrounding 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 patient cables.
Preparation
1 Insert lower pins on panel hinges into the left- and
right-hand slots in bassinet base.
Position panel semi-upright.
2 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.
Install all four panels in the same fashion.
Verify the panels are seated correctly!
To open:
Lift panel all the way up, until upper pins on hinge
brackets are out of their guide slots, then fold down.
22
11
Installing Inside Panels
Use inside panels to protect the baby from falling out when side panel is open.
Insert pins in tapered holes and press down slightly
until the inside panel is firmly seated.
Repeat for second inner panel.
Operating Instructions Babytherm 8000 WB
13
Page 14
Preparation Fitting a Mattress
Installing Cover
Fitting a Mattress
Select mattress type:
– Operation with mattress heating:
Gel mattress 2 M 20 827.
– Operation without mattress heating:
Foam rubber mattress 2 M 21 012.
WARNING !
Always fit correct mattress type for intended mode of operation.
Place the mattress in bassinet and cover it with a
cloth.
14
Operating Instructions Babytherm 8000 WB
Page 15
Tilting the Bed
Tilting the Bed 1 Pull handle of locking mechanism toward front.
2 Push handle down = head-up position.
Pull handle up = head-down position.
Release locking handle, the bed locks into position.
Preparation
1
Maximum tilt angles:
Trendelenburg position: 20° Reverse Trendelenburg position: 15°
The bed can be tilted in fixed steps of 0.5° each only. Preferred positions:
horizontal position, 10° Trendelenburg (head up) and 10° Reverse Trendelenburg position (head down).
2
Operating Instructions Babytherm 8000 WB
15
Page 16
Tests of Readiness for Operation
Tests of Readiness for Operation
Prior to initial operation
Verify that supplied voltage agrees with the values
indicated on the rating plate next to the power cable.
Prior to each use
Has the device been disinfected?
Are the surrounding panels locked securely into place,
and closed?
Are all panels free of cracks and sharp edges?
Is the correct mattress in the bassinet?
Operation with mattress heater gel mattress, operation without mattress heaer: foam rubber
mattress.
Does the bed tilt properly and lock securely into
position?
Is the thermometer in the cover (if applicable)?
Are accessories and therapy equipment available and
in proper working order?
Is the gas supply for any devices used available and
sufficient?
Are all circuits and patient lines installed securely and
properly?
CAUTION !
Never route patient circuits or lines over top of panels – they may get pinched when folding up panels or when installing cover.
Operating Instructions Babytherm 8000 WB
16
Page 17
Heater Safety Precautions
General Precautions During Patient Care
WARNING !
Never leave patient unattended when surrounding panels are down. Risk of patient injury by infant falling out of the bassinet.
WARNING !
When folding up surrounding panels, take care not to pinch patient body parts, circuits, or other items, such as sheets.
Check that all 4 panels are closed and locked
securely into place. The yellow panel fixtures will then be visible above the resting surface.
General Precautions
During Patient Care
Heat Therapy
Heat Therapy
The heating system provided with Babytherm 8000 WB is a mattress heater. Please refer to pages 26 - 28 for information about use of Babytherm 8000 WB in the presence of radiant heaters.
Heater Safety Precautions
WARNING !
Patient Temperature Monitoring
Check the baby´s core temperature at regular intervals and adjust temperature setting to individual patient needs.
The core temperature of the baby must be monitored particularly carefully during phototherapy or while a radiant warmer is used in conjunction with the Babytherm heated bassinet (see pages 26 to 28).
Skin temperature monitoring is no substitute for core temperature checks since the two parameters do not always closely correlate.
Operating Instructions Babytherm 8000 WB
17
Page 18
Heat Therapy Checking Heater Readiness
for Operation
WARNING !
Mattress Heater
When mattress heating is used, the gel mattress must be placed directly on the heated tray surface.
The Dräger gel mattress (part no. 2M 20 827) must not be used in any bassinets other than the Babytherm 8000. Heater plate temperatures
above 40 °C (104 °F) implicate the danger of
patient skin burns! Use of a gel mattress with unheated bassinets would result in patient cooling.
Always take into acount warm-up time of the mattress (approximately 1 hour) before placing a patient in the bassinet.
Do not switch off mattress heater while a baby is lying on the gel mattress as this will result in cooling patient.
Always consider effects of additional sources of heat, such as phototherapy lamps or radiant heaters. They increase the heat directed to the patient. Avoid direct sunlight!
Checking Heater Readiness for Operation
Prior to each use
Verify that gel mattress was disinfected and is in
proper condition.
Lay gel mattress flat on the aluminum heating plate.
Connect plug to power outlet.
WARNING !
To maintain grounding integrity, connect only to a "hospital grade" receptacle.
Operating Instructions Babytherm 8000 WB
18
Page 19
Checking Heater Readiness for Operation
6 7 8 9
Heat Therapy
D
>37 °C <35 °C
°C
°C
40 °C ±1 °C
Inop
Babytherm 8000
Check
1 2 3 4 5
Mattress Heater Control Panel 1 Button for extending range of settings to tempera-
tures 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 Mute button for silencing intermittent audible alarm
for 15 minutes; Yellow LED in button lights up while intermittent audible alarm is silenced.
4 Button for checking function of LEDs, displays and
audible alarm.
10
5 Power switch 6 Display of actual (measured) mattress temperature. 7 Red LED ;
lights up in case of power failure.
8 Red LED 40 °C;
flashes when measured mattress temperature exceeds 40 °C.
9 Red LED ±1 °C;
flashes when measured mattress temperature deviates more than ±1 °C from set value.
10 Red LED Inop;
lights in case of unit malfunction.
Mattress Heater Alarms
±1 °C alarm Red LED ±1 °C (Pos. 4) flashes,
40 °C alarm Red LED 40 °C (Pos. 8) flashes,
Power failure Red LED (Pos. 7) lights up,
Inoperable device Red LED Inop (Pos. 10) lights up.
Operating Instructions Babytherm 8000 WB
actual value display flashes, intermittent audible alarm.
actual value display flashes, continuous audible alarm.
continuous audible alarm.
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 (Pos. 6).
Battery alarm Acc appears on actual value
display (Pos. 6) alternately with measured value. Intermittend audible alarm.
19
Page 20
Checking Heater Readiness for Operation
Heat Therapy
Switching heater unit on and activating self-test
1 Press power switch until it engages = ON.
A microprocessor self-test now checks proper function of the unit.
All LEDs light up; the numeric display shows 88.8,
and an audible alarm will be heard.
2 After approximately 2 seconds, the unit shows the
default set temperature of 37.0 °C (display blinking).
3 The display alternates between = "Set value" and
measured temperature.
4 Press button
p or P
briefly to adopt the default
value as set value.
3 Display now continuously shows the measured
mattress temperature.
5 In case of the display alternating between =
"rechargeable battery" and measured temperature with a simultaneous intermittent audible alarm, this means that the power failure alarm battery is not
charged sufficiently.
After approximately 30 minutes of operation, the battery will be fully charged. The display will then show the measured temperature continuously without an audible alarm.
D
D
D
>36 °C >35 °C
>36 °C >35 °C
>36 °C >35 °C
3
3
5
°C
°C
2
°C
°C
4 4
°C
°C
Babytherm 8000
Check
Check
Check
1
Babytherm 8000
Babytherm 8000
6
To mute the audible alarm:
6 Press alarm silence button G, its yellow LED will
light up. An intermittent audible alarm can be silenced for 15 minutes.
In case of
7 display alternating between Err and measured
temperature, and
8 illuminated red Inop LED
unit inoperative: see p. 33 for troubleshooting.
20
D
>36 °C >35 °C
7
°C
°C
8
Babytherm 8000
Operating Instructions Babytherm 8000 WB
Check
Page 21
Checking Heater Readiness for Operation
Checking LEDs, displays and audible alarm:
1 Press k button:
All LEDs light up for approximately 2 seconds; the numeric display shows 88.8, and an audible alarm is generated.
After that, displays and LEDs go dark and the audible alarm goes off. After 2 seconds, temperature is displayed again.
NOTE: This function check is possible during operation without affecting any of the settings.
Perform check at least once daily.
D
>36 °C >35 °C
Heat Therapy
°C
°C
Babytherm 8000
1
1
Check
Checking power failure alarm
Pull power plug from outlet.
2 Red LED lights up and continuous audible alarm
is generated.
Reconnect power plug.
Unit continues to operate with set values from prior to power failure alarm.
D
>36 °C >35 °C
°C
°C
2
2
Check
Babytherm 8000
Operating Instructions Babytherm 8000 WB
21
Page 22
Operation Operation without Concurrent
Use of a Radiant Warmer
Heater Operation
Operation without Concurrent Use of a Radiant Warmer
37.0 °C
37,0°C
Heater Operation
Heat up mattress to 37 °C. Allow approximately
1 hour for thorough warm-up. During warm-up and in standby mode, cover the gel mattress with a blanket.
Place patient on the gel mattress. Delete, which is
covered with a thin sheet.
CAUTION !
Always use a thin sheet to cover the mattress. Dräger sheet with thermo tiger pattern available under part number 2M 21 272.
WARNING !
Do not obstruct conductive heat transfer by blankets or other insulating covers placed underneath the patient,
With no radiant heater in use:
Cover patient with a blanket.
WARNING !
Do not switch off mattress heater while a baby is lying on the gel mattress as this will result in cooling patient.
Operating Instructions Babytherm 8000 WB
22
Page 23
Heater Operation
Setting a Mattress Temperature
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 down button p
or
, until desired
P
temperature is showing on the display.
Setting temperature outside of the normal range: – extended lower range: 30 °C to 35 °C, – extended upper range: 37 °C to 38.5 °C.
WARNING !
D
>36 °C >35 °C
°C
°C
1 1
Heat Therapy
Babytherm 8000
Check
Set temperatures in the lower extended temper­ature range only on the order of a physician. Watch patient particularly carefully!
2 Press the unlocking button 5,
the yellow LED in the button is lit.
or
3 Hold down the p
temperature is showing on the display.
Within 1 minute, input a temperature above 37 °C or
below 35 °C. Otherwise, the LED in the 5 button will go off and
the extended temperature ranges will be locked again.
When the temperature is outside a range from 5 °C to 45 °C:
three lines in the bottom of the display =
the temperature is below 5 °C
key, until desired
P
D
2
>36 °C >35 °C
°C
°C
3
3
°C
Babytherm 8000
Check
three lines in the top of the display =
the temperature is above 45 °C
NOTE: This may occur e. g. when the Babytherm 8000 WB is stored in ambient conditions beyond the range of 5 to 45 degree Celsius.
Operating Instructions Babytherm 8000 WB
°C
23
Page 24
Heat Therapy Heater Alarms
Shut-Down
Heater Alarms
Deviation from set temperature
In case of deviations greater than ±1 °C between actual and set mattress temperature:
1 The red LED ±1 °C flashes and an intermittent audible
alarm is generated, and
2 the display flashes.
The intermittent audible alarm can be silenced for approximately 15 minutes:
3 Press the G button, its yellow LED will light up. 1 The red LED is lit continuously.
When the actual mattress temperature has returned to a value within ±1 °C of the set temperature:
D
2
>36 °C >35 °C
3
°C
4
°C
1
5
3
Babytherm 8000
Check
– The red LED ±1 °C and the intermittent audible alarm
go off.
After the mattress heater is initially switched on: – The audible alarm is silenced for 1 hour (warm-up).
1 The red LED ±1 °C is lit.
The yellow LED in the
40 °C alarm
G
button is lit.
4 The red LED 40 °C flashes, and a continuous audible
alarm sounds.
5 The display flashes.
NOTE: The continuous alarm cannot be muted.
The alarm stops automatically when the temperature decreases.
Shut-Down
Only for equipment processing between patients.
D
>36 °C >35 °C
3
4
°C
4
5
°C
Babytherm 8000
Check
Operating Instructions Babytherm 8000 WB
Press the power switch all the way = OFF,
then
disconnect power plug from outlet.
NOTE: Observe specified sequence. Otherwise, the power failure alarm will be activated!
24
Page 25
Notes on Mattress Heater Settings
Notes on Mattress Heater Settings
Notes on settings assume use of the mattress heater without any additional radiant heat source. For information on use of the Babytherm 8000 WB in the presence of radiant heater systems, see pages 26 ff.
WARNING !
Patient Temperature Monitoring
Check the baby´s core temperature at regular intervals and adjust temperature setting to individual patient needs.
Always cover patients, and/or dress them.
Heat Therapy
WARNING !
Do not obstruct conductive heat transfer by blankets or other insulating covers placed underneath the patient,
To achieve a neutral balance (heat neither added nor
dissipated): set temperature to 37 °C.
To add heat:
set temperature to, e. g., 38.5 °C.
37.0 °C
37,0°C
Operating Instructions Babytherm 8000 WB
38.5 °C
38,5°C
25
Page 26
Heat Therapy Notes on Mattress Heater
Settings
Operation with Concurrent
Use of a Radiant Heater
To cool patient:
set temperature to, e. g., 36 °C.
WARNING !
Set temperatures in the lower extended temperature range only on the order of a physician. Watch patient particularly carefully!
Operation with Concurrent Use of a Radiant Heater
36.0 °C
36,0°C
WARNING !
Dräger, Inc. cannot warrant or endorse the safe performance of third party radiant heaters for use with the Babytherm 8000 WB. Specifically, combinations with radiant warmers that are not intended for use with heated bassinets bear risks of excessive overall heat transfer to the pa­tient.
We recommend contacting the manufacturers/ distributors of third party radiant heater units regarding compliance of their product with heated bassinets before attempting to use them in conjunction with the Babytherm 8000 WB.
The following notes on settings of Babytherm 8000 WB in the presence of radiant heaters are intended as guidelines only and cannot take into consideration the specifics of individual radiant heater designs.
WARNING !
Patient Temperature Monitoring
Core temperature of the baby must be monitored particularly carefully during phototherapy or while a radiant warmer is used in conjunction with the Babytherm heated bassinet.
Adjust temperature settings to individual patient needs.
Skin temperature monitoring is no substitute for core temperature checks since the two parameters do not always closely correlate.
WARNING !
Phototherapy and the use of infant radiant heater warmers does increase the insensible water loss in infants. The baby's core temperature must be monitored particularly carefully during such treatments. The supply of fluids to the baby must also increased in order to compensate for increased water loss.
Operating Instructions Babytherm 8000 WB
26
Page 27
Operation with Concurrent Use of a Radiant Heater
Do not use the cover. Otherwise, a radiant heater will
have no effect.
Do not cover or dress patient.
Heat Therapy
Using a radiant heater without Babytherm mattress heating
1 Always use a foam rubber mattress!
Do not use a gel mattress without mattress heating, or when mattress heating is switched off (see page 18)!
Operating Instructions Babytherm 8000 WB
36.3 °C
36,3°C
1
27
Page 28
Heat Therapy Operation with Concurrent
Use of a Radiant Heater
Using radiant heaters and mattress heating with a gel mattress
To add warmth from below, in addition to a radiant
heater. Set mattress heater temperature to, e. g., 38 °C, and set skin temperature at the radiant heater to, e. g.,
36.3 °C.
To achieve a neutral balance:
36.3 °C
36,3°C
38,0°C
38.0 °C
Set mattress heater temperature to 37 °C, and set skin temperature at the radiant heater to, e. g.,
36.3 °C.
To cool the patient from below:
Set mattress heater temperature to, e. g., 36 °C, and set skin temperature at the radiant heater to, e. g.,
36.3 °C.
36.3 °C
36,3°C
36.3 °C
36,3°C
37,0°C
37.0 °C
Operating Instructions Babytherm 8000 WB
28
36,0°C
36.0 °C
Page 29
Taking X-Rays
Place x-ray film cassette directly under patient (above
mattress).
Position the X-ray equipment above
Babytherm 8000 WB.
If a radiant heater is in use:
Swivel radiant heater to the side or move radiant
heater stand.
After finishing with x-rays, swivel radiant heater back
over the patient.
Taking X-Rays
Operating Instructions Babytherm 8000 WB
29
Page 30
Care Disassembly
Cleaning / Disinfecting /
Sterilizing
Care
The Babytherm 8000 WB heated bassinet must be thoroughly cleaned and disinfected after each patient, or at least once a week. Perform any disinfection procedures according to established hospital procedures as well as to the following additional instructions.
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
Switch off the device(s), pull power plug, and turn
off all pressurized oxygen and air if used.
WARNING !
Always disconnect power supply before cleaning and disinfecting.
Remove any ancillary patient care equipment from
unit.
Cleaning / Disinfecting / Sterilizing
CAUTION !
Certain components of the bassinet consist of ma­terials that are sensitive to certain organic solvents sometimes used for cleaning and disinfecting (e. g., alcohols, phenols, halogen releasing com-pounds, oxygen releasing compounds, strong organic acids, etc.). Exposure to such substances may cause damage that is not always immediately recognized. Sterilization of the bassinet itself with ethylene oxide (EtO) is also not recommended.
To prevent any damage, we recommend that only de­tergents and disinfectants are used that are compatible with the materials used in the bassinet and its compo­nents and accessories, e. g. surface disinfectants on the basis of
aldehydes, or – quarternary ammonium compounds
for disinfection procedures
Ensure that all disinfectants are registered with the U.S. Environmental Protection Agency for use as intended. Always follow the instruction labels specifically with respect to prescribed concentrations and the necessary exposure times.
Remove mattress from bed.
Store the matress flat only.
CAUTION !
Do not fold gel mattress!
Take off flexible U-grommets.
30
Operating Instructions Babytherm 8000 WB
Page 31
Before Next Use
Cleaning and Disinfection Procedures
– Bassinet, inside and outside – sourrounding panels, inside and outside – resting surface – perspex cover – mattress;
– chassis, including attachments
Remove visible impurities with a disposable cloth
wetted in a detergent.
Wipe-disinfect surfaces.
Wipe and dry with a clean, damp cloth.
– Silicone U-grommets
Wash with a detergent and rinse with clear water.
Bath disinfect parts. Then rinse in clear water and dry;
or
Care
sterilize at 120 °C (248 °F).
CAUTION !
Do not launder mattresses in an automatic washing machine. Do not autoclave mattresses
CAUTION !
Do not expose Babytherm 8000 WB to high level of ultraviolet radiation. It may cause cracks in the PMMA (perspex) parts.
Before Next Use
Reassemble components.
Following wipe disinfection, operate unit for a few
hours without a patient, in order to eliminate any disinfectant residues (at mattress temperature setting of 37 °C).
Before a patient is placed in the Babytherm 8000 WB:
Set up accessories for therapy as needed.
Check operational readiness, see pages 16 and 18.
Verify that mattress is sufficiently preheated.
Operating Instructions Babytherm 8000 WB
31
Page 32
Inspection and Maintenance
Inspection and Maintenance
WARNING !
To avoid 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 supply before servicing.
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.
Replacement of Parts
Preventive Maintenance
Intervals
Replacement of Parts
Gel mattress Cover small cuts or other
damages in the film with adhesive tape.
Silicone U-grommets Replace when brittle or sticky.
Preventive Maintenance Intervals
WARNING !
Preventive Maintenance work on the Babytherm 8000 WB ventilator may be performed by trained and factory authorized staff only.
Inspection and every six (6) months Preventive Maintenance
Regular safety checks every six (6) months
Operating Instructions Babytherm 8000 WB
32
Page 33
Troubleshooting
Mattress Heater
Problem/Message Likely Causes Remedy
Red LED ±1 °C flashes, Measured mattress temperature During operation with radiant heater: actual value display flashes, deviates from set temperature reduce radiant heater output. intermittent audible alarm. by more than ±1 °C.
Red LED 40 °C flashes, Mattress temperature >40 °C During operation with radiant heater: actual value display flashes, reduce radiant heater output. continuous audible alarm.
Red LED lights up, No electrical power Check power connection continuous audible alarm. Check that line power is not
interrupted. Call DrägerService.
Red LED Inop lights up. Device malfunction Call DrägerService. Err appears on actual value display alternately with measured value. Error code is flashing in set value display, continuous audible alarm.
3 flashing dashes »– – –« in the Defective temperature sensors Call DrägerService. middle of the actual value display.
Acc appears on actual value display Backup battery for power failure alternately with measured value. alarm is not charged sufficiently. Press button G, audible alarm Intermittent audible alarm. will be silenced for 15 minutes.
Operate device for 30 minutes,
Height Adjustment (Option)
Problem/Message Likely Causes Remedy
Height adjustment does not work. Motor over-temperature switch Let cool off for
was activated. approximately 15 minutes.
Operating Instructions Babytherm 8000 WB
33
Page 34
What is What Overview
15
14
13
12
11
16
17
WARNING !
DANGER OF PATIENT INJURY
NEVER LEAVE BABY UNATTENDED WHEN
SURROUNDING PANELS ARE DOWN
1
2
3
4
5
6
7
10
9
Overview
1 Cover 2 End panel 3 Side panel 4 Handle with inner unlocking handle for tilting the cot 5 Mattress heater control panel 6 Bassinet 7 Swivel cabinet (option) 8 Column (showing with optional electricl height
adjustment)
9 Foot controls, for optional electric height adjustment
8
1-214-94
10 Chassis with 4 castors, 2 of which can be locked 11 Main WARNING/CAUTION label 12 Accessory mounting rail 13 Inner rail with hook for drainage canister 14 Inner panels, 2 ea., (option) 15 Silicone U-grommets 16 Gel mattress for use with mattress heater;
foam rubber mattress for use without mattress heater
17 Warning label "Never leave baby unattended..."
Operating Instructions Babytherm 8000 WB
34
Page 35
Mattress Heater Control Panel
What is What
6 7 8 9
D
>37 °C <35 °C
°C
°C
40 °C ±1 °C
Inop
Babytherm 8000
Check
1 2 3 4 5
Mattress Heater Control Panel
1 Button for extending range of settings to tempera-
tures 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 Mute button for silencing intermittent audible alarm
for 15 minutes; Yellow LED in button lights up while intermittent audible alarm is silenced.
4 Button for checking function of LEDs, displays and
audible alarm.
10
5 Power switch 6 Display of actual (measured) mattress temperature. 7 Red LED ;
lights up in case of power failure.
8 Red LED 40 °C;
flashes when measured mattress temperature exceeds 40 °C.
9 Red LED ±1 °C;
flashes when measured mattress temperature deviates more than ±1 °C from set value.
10 Red LED Inop;
lights in case of unit malfunction.
Operating Instructions Babytherm 8000 WB
35
Page 36
What is What Labels
DANGER !
RISK OF EXPLOSION IF USED IN THE PRESENCE OF FLAMMABLE ANESTHETICS
WARNING !
DISCONNECT SUPPLY BEFORE SERVICING
REPAIRS ON THIS EQUIPMENT TO BE PERFORMED ONLY BY DrägerService OR ITS AUTHORIZED SERVICE CENTERS
CAUTION !
TO MAINTAIN GROUNDING INTEGRITY, CONNECT ONLY TO A "HOSPITAL GRADE" RECEPTACLE
TO REDUCE RISK OF ELECTRIC SHOCK, DO NOT REMOVE COVER
FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN
WARNING !
DANGER OF PATIENT INJURY
NEVER LEAVE BABY UNATTENDED WHEN
SURROUNDING PANELS ARE DOWN
CAUTION ! KEEP SPACE KEEP SPACE BELOW ABOVE CABINET BASSINET CLEAR WHEN CLEAR WHEN LOWERING RAISING
2
6 7 8/9
1
3
(both sides)
Labels
1 Main WARNING/CAUTION label
CAUTION !
KEEP TOP KEEP SPACE OF STORAGE ABOVE CABINET INCUBATOR CLEAR WHEN CLEAR WHEN LOWERING RAISING
2
5 4
2 Side panel WARNING labels
3 Height adjustment CAUTION labels
36
Operating Instructions Babytherm 8000 WB
Page 37
Labels
WARNING !
DO NOT SWITCH OFF MATTRESS HEATING WHILE A BABY IS LYING ON THE GEL MATTRESS AS THIS WILL RESULT IN COOLING OF THE PATIENT
WARNING !
USE RUBBER MATTRESS WHEN THE HEATING MATTRESS IS COLD. GEL MATTRESS WILL COOL THE INFANT IF MATTRESS HEATING IS SWITCHED OFF
WARNING !
CHECK BABY'S TEMPERATURE AND SKIN CONDITION AT REGULAR INTERVALS AND ADJUST TEMPERATURE SETTING TO INDIVIDUAL PATIENT NEEDS
WARNING !
WHEN USED WITH THE RADIANT WARMER CHECK ITS OPERATORS MANUAL FOR DIRECTIONS OF THE CORRECT HEAT LEVEL AND DISTANCE TO THE BABY
Dräger, Inc. Critical Care Systems 3136 Quarry Rd Telford, PA 18969 Tel: (703) 817-0100 Fax: (703) 817-0101
Babytherm 8000
Typ Fabr. Nr. V A Hz 50/60
Made in Germany Dräger Medizintechnik GmbH
4 Mattress heater WARNING label
5 Mattress WARNING label
6 Baby's temperature WARNING label
What is What
7 Radiant warmer WARNING label
8 Type label, Dräger Inc.
8 Type label, Dräger Medizintechnik GmbH
Operating Instructions Babytherm 8000 WB
37
Page 38
Technical Data
Ambient conditions
For operation: Temperature 20 °C to 30 °C Atmospheric pressure 900 hPa to 1100 hPa Relative humidity 0 to 90%, no condensation
In storage: Temperature –20 °C to 60 °C Atmospheric pressure 750 hPa to 1100 hPa Relative humidity 0 to 90%, no condensation
Electrical safety
Standard IEC 601-1 corresponding to DIN VDE 750 Part 1 Protection class I
Heating surface of mattress Type BF
m
RFI suppression in agreement with EN 55011: 1991 / EN 55014: 1993; VfG 293/1991;
guideline 89/336/EWG
Mattress heating
Line voltage 120 V; 60 Hz Power consumption 160 VA Heating output 120 W Fuses T 1.6 A L 250 V; IEC 127-2/III (two)
Temperature measurement Measurement range 5 °C to 45 °C Accuracy ±0.5 °C Setting range 30 °C to 38.5 °C
Heating surface Type BF
Height adjustment (option)
Line voltage 120 V; 60 Hz Power consumption 560 W
Operating Instructions Babytherm 8000 WB
Fuses T 3.15 A L 250 V; IEC 127-2/III (two) Additional height range 295 mm Operation Maximum operating time of 1 min must be followed
by 60 min cooling time.
38
Page 39
Dimensions
Length x Width 940 x 620 mm (37,0 x 24,4 inches) Total height (with cover)
basic unit without height adjustment 1285 mm (50,6 inches) basic unit with height adjustment 1220 to 1515 mm (48,0 to 59,6 inches)
Working height of the bed surface
without height adjustment 950 mm (37,4 inches)
with height adjustment 885 to 1180 mm (34,8 to 46,5 inches) bed size 750 x 490 mm (29,5 x 19,3 inches) Tilting of bed adjustable in microsteps
maximum of 20 °C down maximum of 15 °C up
Height of surrounding panels 230 mm or 150 mm (9,1 or 5,9 inches) Height of inside panels 70 mm (2,8 inches)
Weight (with cabinet and cover)
basic unit without height adjustment 85 kg (187 lbs)
basic unit with height adjustment 83 kg (183 lbs)
Technical Data
Operating Instructions Babytherm 8000 WB
39
Page 40
Ordering Information
Name and Description Part No.
Babytherm 8000 WB FR 00 050
Voltage level as ordered To be specified with order: – Cover or no cover – Set of side panels, height 230 mm or
set of side panels, height 150 mm
– 2 inner panels or
no inner panels
– Mattress heater with gel mattress or
foam rubber mattress, unheated
– height adjustable column or
fixed column
– Swivel cabinet or
no swivel cabinet
Options (can be retrofitted)
Panels Set of side panels, height 230 mm 2M 21 034
Name and Description Part No.
Consumables
Foam rubber mattress 2M 21 012 for unheated bassinet
Gel mattress 2M 20 827 for use with mattress heater
Mattress cover 2M 21 272 Silicone U-grommet 2M 20 434
Documentation
Service Manual on request
Set of side panels, height 150 mm 2M 21 032 Inner panel, height 70 mm 2M 20 936 Swivel cabinet 2M 20 638
Cabinet installation hardware 2M 20 868
Perspex Cover 2M 21 030
Accessories
Infusion bottle holder 2M 16 520 Inner rail, additional 2M 21 150
for drainage canister
Holder for perspex cover 2M 21 342
Operating Instructions Babytherm 8000 WB
40
Page 41
Index
Alarms...................................................................... 24
Ambient conditions....................................................38
Before next use.........................................................31
Bassinet, preparing................................................... 12
Bed, tilting.................................................................15
Care......................................................................... 30
Checking, heater readiness for operation...................18
Cover..................................................................14, 26
Description............................................................... 11
Disassembly..............................................................30
Disinfection............................................................... 30
Gel mattress....................................................... 14, 28
Heat therapy......................................................17 - 28
Heater
checking readiness for operation......................... 18
operation............................................................. 22
Intended use............................................................. 11
Labels.......................................................................36
Technical data...........................................................38
Temperature settings...........................................21, 28
Tests of readiness for operation...........................16, 18
Tilting bed................................................................. 15
Troubleshooting.........................................................33
WARNINGS and CAUTIONS, General.......................7
What's what.......................................................34 - 37
X-rays, taking............................................................29
Maintenance, preventive intervals.............................. 32
Mattress heating.................................................19 - 24
Mattress types...........................................................14
Ordering information................................................. 40
Power failure alarm, checking....................................21
Precautions
during preparation................................................. 8
during operation................................................ 8, 9
during care............................................................9
during maintenance............................................. 10
Preparing accessories.........................................12, 14
Preparation........................................................ 12 - 15
Radiant heaters...................................................26 -28
Safety precautions, heater.........................................17
Settings, for heat therapy
mattress heater settings.................................25, 26
for operation with concurrent use of a
radiant heater............................................... 26 - 28
Set value range, extending.........................................23
Set values, setting..................................................... 23
Operating Instructions Babytherm 8000 WB
41
Page 42
Notes
42
Operating Instructions Babytherm 8000 WB
Page 43
Notes
Operating Instructions Babytherm 8000 WB
43
Page 44
This Operating Instruction Manual applies only to
Babytherm 8000 WB (FR 00 050) or Babytherm 8000 OC without radiant warmer (FR 00 048)
with Serial No.:
Without entry of a Serial No. by Dräger, these Operating Instructions provide general information only and are not intended for use with a specific device!
Manufactured by
Dräger Medizintechnik GmbH
Germany H Moislinger Allee 53 – 55
D-23542 Lübeck
T (4 51) 8 82 - 0 X 26 80 70
FAX (4 51) 8 82-20 80
Distributed by
Dräger Inc.
Critical Care Systems H 3136 Quarry Road
Telford, PA 18969 T 215-721-6910 FAX 215-721-6915
90 28 327 - GA 6132.210 us Dräger, Inc. 3rd U.S.- Edition November 1995
Subject to modifications
tedok.97 / Printed in Germany / Lot No.: ARLL-F001 / Printed on chlorine free paper
Loading...