D
Babytherm 8004/8010
Infant Warmer System
Operating Instructions
1-214-94
NOTICE
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, the name Babytherm and BabyLink are registered trademarks of Drägerwerk Aktiengesellschaft.
ThermoView and ThermoMonitoring are trademarks of Drägerwerk
Aktiengesellschaft.
Dräger Medizintechnik GmbH 1997
All rights reserved, Subject to modifications
.ed .2 8004/8010, Babytherm Instructions Operating
Operating Instructions Babytherm 8004/8010, 2. ed.
Contents
Contents |
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Page |
Important Safety Information 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....................................... |
11 |
Precautions During Maintenance........................... |
11 |
Intended Use....................................................... |
12 |
Theory of Operation............................................ |
13 |
Description of System Components...................... |
14 |
Alarm System....................................................... |
15 |
Operating Concept............................................... |
16 |
Preparation.......................................................... |
18 |
Preparing Column Accessories............................. |
18 |
Preparing the Bed................................................. |
19 |
Attaching Ventilator Circuit Support Arm............... |
21 |
Supplies Storage Options .................................... |
21 |
Adjusting the Height (Option) ............................... |
21 |
Preparing for Intra-Hospital Patient Transport ....... |
22 |
Testing Readiness for Operation ....................... |
23 |
Before First Use................................................... |
23 |
Before Each Use.................................................. |
23 |
Operation ........................................................... |
26 |
Precautions During Patient Care.......................... |
26 |
Using the Radiant Heater .................................... |
28 |
Setting Heater Output Manually .......................... |
28 |
Using Skin Temperature Control ......................... |
30 |
ThermoMonitoring ............................................... |
35 |
Switching Radiant Heater Off................................ |
36 |
Using Mattress Heater (Babytherm 8010) ........... |
37 |
Notes on Heater Settings .................................... |
40 |
Using Phototherapy (Available Option).................. |
43 |
Configuration Mode.............................................. |
44 |
Switching Lighting On/Off.................................... |
48 |
Central Alarm....................................................... |
48 |
Taking X-Rays ..................................................... |
49 |
Shutting Down...................................................... |
49 |
Care .................................................................... |
50 |
Disassembly......................................................... |
50 |
Cleaning/Disinfecting/Sterilizing............................ |
51 |
Before Next Use ................................................. |
51 |
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Page |
Inspection and Maintenance............................... |
52 |
Replacement of Parts............................................ |
52 |
Preventive Maintenance Intervals.......................... |
52 |
Troubleshooting.................................................. |
53 |
General................................................................ |
53 |
Radiant Heater...................................................... |
53 |
Mattress Heater.................................................... |
54 |
What's What........................................................ |
55 |
Overview.............................................................. |
55 |
Radiant Heater...................................................... |
56 |
Controller............................................................. |
57 |
Controller - Rear View.......................................... |
59 |
Labels.................................................................. |
60 |
Technical Data..................................................... |
61 |
Ordering Information........................................... |
65 |
Index ................................................................... |
66 |
3
Important Safety Information
Operator's Responsibility for Patient Safety Limitation of Liability
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.
Patient monitoring
The operators of the infant warmer 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.
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.
.ed .2 8004/8010, Babytherm Instructions Operating
4
Important Safety Information
Warranty
Warranty
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.
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., Telford, PA
Operating Instructions Babytherm 8004/8010, 2. ed.
5
Important Safety Information
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 |
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condition |
Repair |
= measures to restore specified |
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condition |
Maintenance |
= inspection, service, and repair, |
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where necessary |
Preventive |
= Maintenance measures at regular |
Maintenance |
intervals |
Typing conventions in this manual
Display messages are printed in bold type, e. g:
Battery discharged
Controller keys are designated as »Key Name«, e.g.
»man.«
.ed .2 8004/8010, Babytherm Instructions Operating
6
Operating Instructions Babytherm 8004/8010, 2. ed.
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" (see page 12). 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.
WARNING !
Do not use cellular phones within 33 feet (10 m ) of the equipment.
Wireless phones may cause malfunction in electromedical equipment.
Important Safety Information
General WARNINGS and CAUTIONS
WARNING !
Skin temperature control must not be used with babies in shock. Because of reduced peripheral blood flow the skin temperature of these babies occasionally lies well below the core body temperature. Using a skin temperature control system could lead to overheating. We recommend to set heater output manually when caring for patients with such conditions.
WARNING !
Do not use skin temperature control for infants with a high temperature. Their skin temperature is significantly higher than normal so that controlling skin temperature would lead to hypothermia. We recommend to set heater output manually when caring for patients with such conditions.
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.
Device for use only in health care facilities and only used by persons with specific training and experience in the use of the device.
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 8004/8010 shall be performed only by Dräger authorized technical service representatives.
7
Important Safety Information
Precautions During Preparation
Precautions During Operation
Precautions During Preparation |
Precautions During Operation |
WARNING ! |
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WARNING ! |
Always select correct mattress type for |
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Never leave patient unattended when |
intended mode of operation (see page 20). |
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surrounding panels are down. Risk of patient |
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injury by infant falling out of the bassinet. |
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WARNING !
To maintain grounding integrity, connect only to a "hospital grade" receptacle.
CAUTION !
Always verify that monitor shelves and other accessories are securely attached.
Always observe the following load limits per shelf: not to exceed 20 kg (44 lbs).
total load on both columns: max. 30 kg (66 lbs).
For items attached to column on swivel shelves, do not exceed load of 5 kg on that column.
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.
CAUTION !
Always use circuits and patient lines with sufficient length for secure connection at minimum and maximum height.
CAUTION !
Always observe the load limit of 50 kg on the electric height adjustment.
WARNING !
For lively and greater babies use side panels of 23 cm height and additional inner panels. Supervise the baby corresponding to its liveliness.
WARNING !
When folding up surrounding panels, take care not to pinch patient body parts, circuits, or other items, such as sheets.
WARNING !
Continuous or intermittent audible alarms require immediate operator attention to avert or to prevent development of situations with the possibility of patient injury.
WARNING !
All accessories used must comply with national safety standards for electromedical equipment used in patient rooms
(e.g. IEC 601.1).
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 the radiant heater is used in conjunction with mattress heater.
Skin temperature monitoring is no substitute for core temperature checks since the two parameters do not always closely correlate.
.ed .2 8004/8010, Babytherm Instructions Operating
8
Operating Instructions Babytherm 8004/8010, 2. ed.
WARNING !
Mattress Heater (Babytherm 8010 only)
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. 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 uncontrolled patient cooling.
Always take into account warm-up time of the mattress (approximately 1 hour) before placing a patient in the bassinet.
Do not switch off Babytherm while a baby is lying on the gel mattress as this will result in uncontrolled cooling of patient .
WARNING !
Do not touch top of radiant heater or protective screen.
Danger of burn injuries!
WARNING !
Do not use flammable detergents, or medications while radiant heater is in operation.
Fire hazard!
WARNING !
Never leave baby unattended while radiant warmer is in operation!
Measure core temperature at regular intervals!
WARNING !
Do not put any medications or infusion solutions in the heated area.
Important Safety Information
Precautions During Operation
WARNING !
Skin temperature control must not be used with babies in thermic shock. Because of reduced peripheral blood flow the skin temperature of these babies occasionally lies well below the core body temperature. Using a skin temperature control system could lead to overheating. We recommend to set heater output manually when caring for patients with such conditions (see page 28).
WARNING !
Do not use skin temperature control for infants with a high temperature. Their skin temperature is significantly higher than normal so that controlling skin temperature would lead to hypothermia. We recommend to set heater output manually when caring for patients with such conditions (see page 28).
WARNING !
Always operate phototherapy lights in combination with radiant heater. Otherwise risk of hypothermia for the undressed infant.
Core temperature of the baby must be monitored particularly carefully during phototherapy because of the additional transfer of thermal energy to the patient.
WARNING !
Fire Hazards from oxygen !
–No open flames or cigarettes !
Textiles, plastics, and oils readily ignite in an oxygen enriched atmosphere and burn with great intensity.
–Keep oxygen valves, connections, and seals free from oil and grease.
–Open valves slowly
–Do not operate Babytherm in the presence of flammable anesthetics or disinfectants
–Do not use or store flammable liquids such as alcohol, ether, or acetone inside the Babytherm bassinet.
–Do not use electrical equipment inside hood with the exception of devices approved for use in explosive environments.
9
Important Safety Information
Precautions During Operation
WARNING !
Physiological risks of oxygen !
–Oxygen therapy only on the order of a physician
–Elevated oxygen concentrations must be selected on the basis of arterially measured oxygen partial pressure in the patient's blood. Otherwise risk of hyperoxemia (eye injuries with consequential blindness) or hypoxemia (brain injuries).
–Monitor oxygen concentration at all times during oxygen therapy.
WARNING !
Always verify that sensor probe is specified and approved for use with Dräger Babytherm Radiant Warmer 8004/8010.
WARNING !
The sensor probe must never be placed under the baby. It would be measuring and attempting to control core temperature rather than skin temperature.
WARNING !
Never use skin temperature probes for rectally measuring core temperature !
Specifically, never use skin temperature probe rectally for skin temperature control as this would measure and use core instead of skin temperature for control.
WARNING !
When using skin temperature control mode, check infant skin condition at regular intervals and verify that skin temperature probe is securely attached. A detached probe will measure air temperature and the baby might become overheated.
WARNING !
Always warm up mattress before placing patient.
Do not switch off Babytherm while a baby is lying on the gel mattress as this will result in uncontrolled cooling of patient.
WARNING !
Use temperature settings in the lower extended temperature range only on the order of a physician. Watch patient particularly carefully!
WARNING !
Always use patient eye protection when using phototherapy.
WARNING !
Always consider differentiated diagnosis for patient so life sustaining measures are not delayed.
WARNING !
Check the baby´s core temperature at regular intervals. Phototherapy increases heat transfer to patient.
Measure patient's bilirubin level at regular intervals
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.
.ed .2 8004/8010, Babytherm Instructions Operating
10
Operating Instructions Babytherm 8004/8010, 2. ed.
Precautions During Care
WARNING !
Always follow accepted hospital procedures for handling equipment contaminated with body fluids.
Important Safety Information
Precautions During Care
Precautions During Maintenance
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 !
Always disconnect power supply before cleaning and disinfecting.
CAUTION !
Do not fold gel mattress!
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 compounds, 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.
CAUTION !
Do not expose Babytherm 8004/8010 to high levels of ultraviolet radiation. This may cause cracks in the PMMA (acrylic glass) parts.
CAUTION !
Do not launder mattresses in an automatic washing machine. Do not autoclave mattresses.
CAUTION !
Only use detergents/disinfectants with a ph value of 7 to 9 for phototherapy lenses.
WARNING !
Maintenance work on the Babytherm 8004/ 8010 may be performed by trained and factory authorized staff only.
WARNING !
Always disconnect power supply before servicing.
WARNING !
Never operate the infant warmer system 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.
11
Intended Use
Intended Use
Babytherm 8004/8010 is an infant warmer system intended as a therapeutic device providing warmth for premature and full-term neonates and infants with a weight up to16 lbs. It is intended for use in delivery rooms, operating theatres, maternity and obstetric units, neonatal wards, neonatal and paediatric intensive care units. Both systems can be equipped with the optional phototherapy system for treatment of hyperbilirubinemia.
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.
Device for use only in health care facilities and only used by persons with specific training and experience in the use of the device.
Babytherm 8004 warms with a radiant heater providing both "manual control" and "skin temperature control" modes.
Babytherm 8010 warms with a radiant heater providing both "manual control" and "skin temperature control" modes as well as with a heated gel mattress.
Therapy and nursing uses:
–Resuscitation table
–Bassinet for use in normal and intensive care
–Patient re-warming and prevention of heat loss
–Thermal stabilizing of a patient with mattress heater (Babytherm 8010, only)
–Gentle warming therapy using the combination of radiant and mattress heater (Babytherm 8010, only)
–Cooling patients with high temperatures (mattress temperature below body temperature;
Babytherm 8010, only)
–ThermoMonitoring by tummy-toe temperature measurement for improved feedback of the thermal condition of a patient
–Trendelenburg and reverse Trendelenburg positioning
–Weaning of incubator patients to standard (unheated) bassinet
–Oxygen and aerosol inhalation therapy with appropriate accessories
–Phototherapy for lowering of patient blood bilirubin levels (with phototherapy option)
–X-Ray assistance
Options
–Power column for electric height adjustment
–One or two (with power column installed) swivel cabinets
–Double (inner) walls
–IV-pole
–Phototherapy
–Hood
–Swivel tray
Optional accessories
–Bronchial suction equipment
–O2-management accessories (flowmeter, headhood, monitor)
–Interface for data output
.ed .2 8004/8010, Babytherm Instructions Operating
12
Operating Concept
Overview
Overview |
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Mattress °C |
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man. |
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°C |
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Inop. |
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manual |
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man.
OK
Operating Instructions Babytherm 8004/8010, 2. ed.
13
Theory of Operation
Description of System Components
Description of System Components
Babytherm consists of
–a mobile chassis with the attached infant bed
–a controller unit with operating panel
–a radiant heater, and
–a mattress heating system (Babytherm 8010 only)
Controller unit
The controller unit is located below the radiant warmer between the two support columns at the head end of the bed. The panel contains a membrane keypad and display area. Integrated into the alphanumeric display (2 x 40 characters) is a user guide for easier operation.
Radiant heater
The radiant warmer combines two infrared ceramic heaters and 2 lights for illuminating the bed surface. An integrated phototherapy light is optional.
The work light provides two settings, for daytime and for nighttime lighting. The well balanced color spectrum of the lamps used makes it easier to recognize diagnostically significant skin color nuances.
The radiant warmer can be operated in manual control mode or skin temperature control mode.
"Manual" control mode provides fixed heater output level settings from 1 through 10.
"Skin control" controls skin temperature according to a preset value. Heater output is then automatically controlled to patient needs.
Both modes of operation are monitored with check routines and alarm schemes.
ThermoMonitoring
ThermoMonitoring is made possible with a secondary skin temperature sensor. Skin temperatures taken close to the body core and at the periphery (tummy-toe temperature monitoring) are displayed on the controller unit. They can be graphically represented on a PC via optional serial interface (RS 232), using Dräger's ThermoView software, improving diagnostic possibilities.
Mattress heating
The Babytherm 8004/8010 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 is made 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 facilitating heat conduction to the patient and avoiding pressure points (anti-decubitus effect). A cold gel mattress, on the other hand, dissipates a patient's 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.
The mattress heater membrane keypad with its buttons and display is located on the right-hand side of the controller unit.
Mattress temperature is controlled according to the set value entered. It adjusts in such a way that the set temperature is reached (but not exceeded) in those areas where the patient is in contact with the mattress. System monitoring includes check routines and alarm features.
Configuration mode
Configuration mode is a special operational mode of the Babytherm 8004/8010 controller. In this mode, information regarding software version and error log cna be polled. The device can also be programmed with user specific settings of skin temperature alarm threshold, volume of audible alarms, as well as language and contrast of the alphanumeric display. It also serves to test the built-in nurse call and keys of the operating panel.
.ed .2 8004/8010, Babytherm Instructions Operating
14
Theory of Operation
Description of System Components
Phototherapy (available option)
Light from the halogen lamps contributes to photochemical breakdown of bilirubin in the skin. Dräger halogen lights emit very effectively at wavelengths around 460 nm without the blue light often
associated with phototherapy. They therefore provide for good skin color representation.
Phototherapy is switched on the main controller panel.
Modes of heater operation Babytherm 8004
–Operation of radiant heater with preset heater output: Heater output is controlled in "manual" mode and therapy is time-limited for higher heater output settings.
–Operation of radiant heater in "skin control" mode: Skin temperature is monitored and controlled.
Modes of heater operation Babytherm 8010
–Operation of radiant heater with preset heater output: Heater output is controlled in "manual" mode and therapy time-limited for higher heater output settings.
–Operation of radiant heater in "skin control" mode: Skin temperature is monitored and controlled.
–Mattress heater, independent of radiant heater: Temperature of heating surface monitored and controlled to maintain a preset temperature in the contact area between infant and mattress.
Operating Instructions Babytherm 8004/8010, 2. ed.
15
Theory of Operation
Alarm System
Alarm System
The Babytherm controller distinguishes three levels of alarms.
High potential for patient risk
a continuous audible alarm (enunciator) that cannot be silenced, for:
–device malfunction,
–power failure
an alarm tone sequence (loudspeaker) that can be silenced in combination with flashing red LED, for:
–mattress heater sensor failure,
–mattress heater exceeding temperature limits,
–skin temperature sensor not connected during skin control,
–sensor failure of tummy or toe skin temperature sensor.
Medium potential for patient risk
an alarm tone sequence (can be silenced ) in combination with flashing yellow LED, for:
–deviation between set and measured value for skin or mattress temperature exceeding tolerance,
–15-minute alarm (as a reminder to check core temperature during manual mode with heater levels higher than 3).
Low potential for patient risk
Display messages for:
–measured values out of measuring range,
–low battery voltage.
Any alarm that has not been acknowledged is indicated by flashing red central alarm light on the radiant heater unit.
The display shows a specific message for the alarm activated.
NOTE: A new alarm being activated will always override audible alarm silencing.
Central Alarm
1Red light on radiant heater starts flashing simultaneously with any audible alarms.
Acknowledging the alarm will switch light off.
1 |
.ed .2 8004/8010, Babytherm Instructions Operating
16
Operating Instructions Babytherm 8004/8010, 2. ed.
Theory of Operation
Operating Concept
Operating Concept
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>38°C |
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Inop. |
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Mattress °C |
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man. |
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Status LEDs
Green LED continuously on during operation. Red LED continuously on during power outages.
»OK« key for confirming settings and to acknowledge alarms.
NOTE: If the »OK« key is not pressed within
10 seconds after changing a setting, the previous settings will remain in effect!
Red indicator LED for "Inop." alarm.
Key for testing LEDs, displays, enunciator, and audible alarm.
Key for silencing audible alarms.
Visual display of alarms:
Warning = red LED, Caution = yellow LED.
Text display, shows user messages and alerts.
Babytherm 8010 only – display and keypad for operating mattress heater:
top: display of measured mattress temperature; bottom: display of set value for mattress temperature with keys for setting;
to the right: indicator for operation in extended range high (>38 °C), low (<36 °C).
Display and keypad for radiant heater:
top: display for measured values of skin temperatures close to core (tummy) and at periphery (toe);
bottom: Set value for skin temperature using keys for changing set value and key for switching between manual and skin temperature control mode. The currently active mode is indicated by the respective yellow LED;
Further to the right: bar graph for displaying heater levels 1 through 10 for manual mode operation Heater levels 1 to 3 = green bar elements,
Heater levels 4 to 10 = yellow bar elements, and below, keys for setting heater levels.
On/Off keys for switching: work light,
night light,
phototherapy (available option) radiant heater.
The respective yellow LEDs are lit during operation.
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Preparation
Preparing Column Accessories
Preparation
Preparing Column Accessories
Monitor shelf
Babytherm comes equipped with one monitor shelf.
Mounting rail elements (available option) to monitor shelf:
●Attach rail element to left and/or right of monitor shelf with screws provided.
CAUTION !
Always verify that monitor shelves and other accessories are securely attached.
Always observe the following load limits per shelf: not to exceed 20 kg (44 lbs).
total load on both columns: max. 30 kg (66 lbs).
For items attached to column on swivel shelves, do not exceed load of 5 kg on that column.
Compact rail
For placing smaller accessories, e.g. O2 flowmeter, O2 monitor.
●Attach compact rail element to one of the columns at a convenient height.
Instrument tray
For small instruments, maximum load capacity 3 kg (6.5 lbs).
●Put clamp of instrument tray on one of the columns and tighten hand screw.
Recommended height: mattress level.
●Keep area clear for swiveling tray.
See above CAUTION for load limits to maintain a safe level of stability against tipping over pursuant IEC standards.
.ed .2 8004/8010, Babytherm Instructions Operating
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Operating Instructions Babytherm 8004/8010, 2. ed.
Preparing the Bed
The bed 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.
Installing surrounding panels
1Insert lower pins on panel hinges into the leftand right-hand slots in bassinet base.
● Position panel semi-upright.
2Press panel down firmly, until pins lock into position at the bottom of slots.
●Tilt panel fully upright and let it slide into locking position.
●Install all four panels in the same fashion.
Verify that 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.
Installing inside panels
Use inside panels to protect the baby from falling out when side panels are open.
●Insert pins in tapered holes and press down slightly until the inside panel is firmly seated.
●Repeat for second inner panel.
WARNING !
For lively and greater babies use side panels of 23 cm height and additional inner panels. Supervise the baby corresponding to its liveliness.
Preparation
Preparing the Bed
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Preparation
Preparing the Bassinet
Fitting a mattress
● Select mattress type:
–Operation with mattress heating (Babytherm 8010 only):
Gel mattress 2M 20 827.
–Operation without mattress heating (Babytherm 8004):
Foam rubber mattress 2M 21 012.
WARNING !
Always select correct mattress type for intended mode of operation.
●Place the mattress in bassinet and cover it with a thin sheet.
NOTE: Do not obstruct conductive heat transfer by blankets or other insulating covers placed underneath the patient.
Tilting the bed
1 Pull handle of locking mechanism toward front.
2Push handle down = head-up position. Pull handle up = head-down position.
● Release locking handle, the bed locks into position.
The bed can be tilted in increments of 0.5°.
Maximum tilt angles:
Trendelenburg position: 20° Reverse Trendelenburg position: 15°
Preferred positions: horizontal position,
10° Trendelenburg (head up) and
10° reverse Trendelenburg position (head down).
At max. tilt angle the mattress can slip from its position:
●In this case don't place sheet underneath the mattress.
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.ed .2 8004/8010, Babytherm Instructions Operating
20
Operating Instructions Babytherm 8004/8010, 2. ed.
Preparation
Attaching Ventilator Circuit Support Arm
Supplies Storage Options
Adjusting the Height (Option)
Attaching Ventilator Circuit Support Arm
●Insert flexible support arm into hole in the left side of head panel and tighten with knurled screw.
Supplies Storage Options
Units with height adjustable column:
–swivel cabinet (available option) with 2 compartments and 1 swivel tray
Units without electric height adjustment:
–2 open compartments in the column (standard),
or
–1 swivel cabinet with 2 compartments and
1 swivel tray (available option).
Adjusting the Height (Option) |
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1 Briefly depress right pedal. |
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The bassinet is raised. |
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2 Briefly depress left pedal. |
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The bassinet is lowered. |
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● Adjust to comfortable working height. |
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CAUTION ! |
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Do not place any objects above or underneath |
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bassinet where they might be damaged when |
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height adjustments are made. |
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CAUTION ! |
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Always use circuits and patient lines with sufficient |
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length for secure connection at minimum and |
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maximum height. |
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CAUTION !
Always observe the load limit of 50 kg on the electric height adjustment.
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