Giraffe Warmer Operation and Maintenance Manual Rev E

© 2007 - 2017 General Electric Company All rights reserved. General Electric Company reserves the right to make changes in specifications and features shown herein, or discontinue the product described at any time without notice or obligation. Contact your GE Representative for the most current information. Panda is a trademark owned by Datex-Ohmeda, Inc. GE and GE Monogram are trademarks of General Electric Company. All other company and product names mentioned may be trademarks of the companies with which they are associated.

Table of Contents __________________________________________ Important Safety Information... v Warnings, Cautions and Notes...v Symbols...vii About this Manual... ix Scope and Users... ix Organization of this manual... ix References... x Chapter 1 - Introduction... 1-1 System Description and Indications for Use... 1-1 Mechanical Controls and Cable Connections... 1-2 Controls and Displays... 1-5 Temperature Regulation... 1-6 Control Modes... 1-7 On-Screen Help... 1-8 Home Screen...1-10 Scale (optional)...1-12 Trends...1-13 Setup...1-15 Alarms...1-17 Temperature regulation alarms...1-19 Alarm Table...1-23 Chapter 2 - System Setup and Checkout Procedures... 2-1 Mechanical checks... 2-1 Controller checks... 2-4 Optional equipment checks... 2-7 Chapter 3 - Operating the Warmer... 3-1 Basic Operating Procedure... 3-1 Start up... 3-3 Giraffe Warmer Flow Chart... 3-7 Attaching the Skin Temperature Probe... 3-8 Setting the manual temperature alarm...3-11 Raising or lowering the bedside panels...3-13 Tilting the bed...3-14 Raising and lowering the bed...3-15 Rotating the mattress...3-16 Using the X-ray tray...3-16 Using the observation and procedure lights...3-17 Uninterruptible Power Supply (UPS)... 3-17 Using the In-Bed Scale...3-18 Using the Integrated SpO2 Monitor (optional)...3-22 Using the Integrated Resuscitation System (optional)...3-22 Mounting Optional equipment...3-22 ThermaLink option...3-24 Using the Serial Data interface...3-24 Nurse Call checkout...3-25

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Chapter 4 - Maintenance and Cleaning... 4-1 Repair Policy... 4-1 Maintenance schedule... 4-2 Cleaning Instructions... 4-3 Cleaning the Warmer... 4-4 Cleaning Solutions... 4-5 Cleaning and disinfecting individual components...4-6 Patient Probe (reusable)... 4-6 Cleaning other components... 4-7 Appendix A - Options... A-1 Appendix B - Specifications... B-1 Power Requirements and Accessory Outlets... B-1 Standards... B-1 Operating Environment... B-1 User Control Settings... B-1 Performance... B-2 Mechanical Specifications... B-2 Uninterruptible Power Supply (UPS) Specifications...B-2 Appendix C - Electromagnetic Compatibility... C-1 Appendix D - Conforming with Standards and Directives...D-1 Appendix E - Additional Safety Information...E-1 GE Service Centers...inside back cover

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Important Safety Information __________________________________________ Before using the Giraffe Warmer, read through this entire manual. As with all medical equipment, attempting to use this device without a thorough understanding of its operation may result in patient or user injury. This device should only be operated by personnel trained in its operation under the direction of qualified medical personnel familiar with the risks and benefits of this type of device. Additional precautions specific to certain procedures are found in the text of this manual. Complete the checkout procedures in this manual before putting the unit into operation. If the unit fails any portion of the checkout procedure it must be removed from use and repaired. Do not use the warmer in the presence of flammable anesthetics; an explosion hazard exists under these conditions. Device alarms are readable only at a viewing angle of 129° from the front of the device. Position the device for appropriate view of the display. In the event of loss of Mains power the unit will enter a power fail alarm condition. While in power fail alarm condition a single red LED will be lit at the left side of the alarm light display. The audible alarm is a repeating series of three rapid beeps separated by a short pause. The unit will remain in power fail alarm condition for up to ten minutes, or until mains power is restored. If mains power is restored in less than 10 minutes the unit will return to operation with the same settings as when power was lost. If mains power has not been restored within ten minutes the unit will shut down and the LED indicator and alarm tones will cease. Upon restart of the system after a loss of power of greater than 10 minutes the user may need to reset SpO2 parameters. Always disconnect the power before performing service or maintenance procedures detailed in this manual. Apply power only if you are specifically instructed to do so as part of the procedure. Thoroughly air dry the warmer after cleaning it with flammable agents. Small amounts of flammable agents, such as ether, alcohol or similar cleaning solvents left on the warmer can cause a fire. Only competent individuals trained in the repair of this equipment should attempt to service it as detailed in the Service Manual. Detailed information for more extensive repairs is included in the service manual solely for the convenience of users having proper knowledge, tools and test equipment, and for service representatives trained by GE Healthcare.

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WARNINGS, CAUTIONS, NOTES, and SYMBOLS: This section introduces the various

types of warnings, cautions information notes and symbols used in this guide to alert you to possible safety hazards and to provide you with additional information. WARNING: A Warning statement is used when the possibility of injury to the patient or the operator exists.

CAUTION: A CAUTION statement is used when the possibility of damage to the equipment exists. NOTE: A Note provides additional information to clarify a point in the text.

Warnings, Cautions and Notes This section identifies general warnings, cautions and Notes associated with the use of the Giraffe Warmer. WARNING: As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. WARNING: Do not lean against side of warmer. Leaning against the side of the warmer may cause it to tip over. CAUTION: U.S. Federal law restricts this device to sale by, or on order of, a licensed medical practitioner. CAUTION: This device is for professional use only. For professional use only

NOTE: Ranges listed in this supplement manual represent the operational ranges of the equipment. The gauge ranges may exceed operational ranges. NOTE: Air always means medical grade air. NOTE: Additional copies of this manual are available on request from the GE Healthcare office listed on the inside back cover of this manual.

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SYMBOLS:

This section identifies the symbols that are displayed on the device. Equipment configurations can differ. Labels or symbols may not appear on every device:

Symbol

Description Type B Equipment Functional Earth Terminal Protection Earth Terminal Alternating Current Alarm Silence European Union Representative Consult instructions for use Catalog Number Serial Number Manufacturer Do not reuse Help menu Patient temperature Observation light Scale Date of manufacture Do not lean on warmer Dispose of electrical and electronic equipment as unsorted municipal waste; must be collected separately Increase/decrease, up/down

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FOR PROFESSIONAL USE ONLY

Equipment shall be used only by qualified, trained medical personnel. Do not place items in path of heat. Pinch hazard Ground Equalization Potential Post

UDI

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Unique Device Identifier. The UDI is a unique marking for identification of the medical device.

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About this Manual __________________________________________ Scope and intended users This manual describes the features and operation of the Giraffe Warmer. The Giraffe Warmer is used in hospital delivery rooms, hospital newborn nurseries and neonatal intensive care units (NICU). The intended users of this manual consists of end users of the equipment, primarily care providers in infant delivery rooms and NICUs, and hospital biomedical engineering services.

Organization of this manual The organization of this manual is: Important Safety Information provides important safety information for the safety of both the patient and the care providers. Chapter 1 - Introduction describes the Giraffe Warmer system and the system’s indications for use. Chapter 2 - System Setup and Checkout Procedures describes the procedures to set up and check out the Giraffe Warmer prior to use. Chapter 3 - Operating the Warmer describes the procedures to operate the Giraffe Warmer. Chapter 4 - Maintenance and Cleaning provides information on performing maintenance and cleaning of the Giraffe Warmer. Appendix A - Options is a list of options that may be used with the Giraffe Warmer. Appendix B - Specifications provides information on power requirements and accessory outlets, standards, operating environment, storage conditions, user control settings, performance and mechanical specifications. Appendix C - Electromagnetic Compatibility (EMC) provides information on the Giraffe Warmer’s electromagnetic emissions and the electronic environment that is compatible with the use and operation of the Giraffe Warmer. Appendix D - Conforming with Standards and Directives provides information on the European Council Directive and the disposal of electrical/electronic equipment. Appendix E - Additional Safety Information provides information on IEC 60601-1 3rd edition requirements Inside back cover provides a geographically organized list of Datex-Ohmeda service centers.

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ix

References References to other manuals pertaining to the Giraffe Warmer are: • • • • • •

x

Panda iRes Warmer Operation and Maintenance Manual, M1110737 SpO2 - Masimo SET Option, Operation and Maintenance Supplement M1110918 Resuscitation System, Bag and Mask Option, Operation and Maintenance Supplement M1110023 Resuscitation System, T-piece Option, Operation and Maintenance Supplement, M1109204 Service Manual - Resuscitation Giraffe and Panda Warmers, M1128929 Service Manual - Giraffe and Panda Warmers, M1128921

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Chapter 1

Introduction __________________________________________ The Giraffe Warmer includes: • Recessed heater dish • Dimmable observation lights • Aimable procedure light • Dovetail rail system • Hands Free Alarm Silence • Graphical trending features • Timer • Callback timer • Full color control panel • Progressive, adjustable alarms • Rotating and translating mattress deck • Pressure-diffusing mattress • Bed Tilt • Chest tube drainage hanger Optional Features include: • Integrated resuscitation system • Integrated SpO2 monitor • Tubing management wall • Oscillator wall • In-bed weighing scale • Elevating base • Multiple drawer packages • Options

System Description and Indications for Use Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate’s transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). An optional integrated resuscitation system may be used to provide the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant.

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1-1

Mechanical Controls and Cable Connections 1

1 2 3 4 5

6 7 8

Figure 2: Giraffe Warmer, front oblique view

Description

Feature number

1 2 3 4 5 6 7 8

1-2

Two dimmable observation lights Aimable procedure light Procedure light “On/Off” switch Color display screen Resuscitation system (optional) Baby Susan rotating mattress, with integrated scale Front bedside panel Bed tilt control lever

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22 21 20 19 18

10 11 12

17 16

13

Figure 3: Giraffe Warmer, side view

Description

Feature number

9 10 11 12 13 14 15 16 17 18 19 20 21 22

Giraffe Warmer

15 14

Recessed radiant heater Side bedside panel Front handle Pass through drawers Two height adjustment pedals, up and down Four caster wheels Four brakes Elevating column Tank guard (optional) Scale cable connector Temperature probe jack High pressure air/oxygen yoke (optional) Maneuvering handle and cord wrap Dovetail rail

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1-3

Mechanical Controls and Cable Connections (continued)

23

28

24

27

26 25

Figure 4: Giraffe Warmer, rear view

Description

Feature number

23 24 25 26 27 28

RS 232 connector Two accessory power outlets SpO2 jack Removable rear bedside panel Power cord inlet Mains power switch NOTE: For equipment installation instructions, refer to the Service Manual.

1-4

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Controls and Displays 6 7 5 4 8 3 2 11

10

1

9

Figure 5: Control panel and color screen display Feature number

Description

1

Power stand-by switch - On the left below the display turns the power to the warmer “On” and “Off”. Oximetry key (optional) - This key retains its same fuction at all times. Mode key - To select manual or baby mode. This key retains its same fuction at all times Temperature/power increase/decrease key - This key retains its same fuction at all times Baby temperature - Can be displayed in degrees Celsius or degrees Fahrenheit. The default setting is degrees Celsius. Alarm silence key - Alarms can be silenced by pushing the key above the display or by a wave of your hand directly in front of the alarm light. Help key - The key with the “?” in the upper right corner brings up the help screen that explains alarms and functions. Task keys - The five keys on the right are “soft” keys that change their function depending on what task you wish to perform. They control equipment settings and options. Dimmer knob - On the right controls the brightness of the observation lights. Date and time - Displayed at the bottom of the screen.

2 3 4 5 6 7 8

9 10-11

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1-5

Temperature Regulation Screen

Step

Description

1

At start up, if the Giraffe unit was used in the last two hours, the display will ask if you would like to “Clear Patient History”. Pushing “Yes” deletes the previous settings, and pushing “No” retains previous settings. When neither key is pushed, the “Clear Patient History” screen eventually disappears and the unit uses previous settings. At start-up, if unit has been off for more than two hours, previous settings are not saved.

WARNING: Do not place the baby in the bed while in Warmup Mode. Warmup Mode is used to quickly warm and maintain heat to an empty bed. Warmup Mode is not designed for clinical use with a baby since the Check Baby Alarm is disabled.

Warmup Mode Screen

Step

1

Description The Giraffe Warmer automatically starts in Warmup Mode. During Warmup Mode “Check Baby” alarms are deactivated. If you do not press the “Admit Baby” key during the first minutes after start up, the display will show “Warming...” and the radiant heater will automatically run at 100% power.

2

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After 7 minutes, the display indicates “Warmup Complete…” and the default heater power setting drops to 50%. The display continues to flash “Admit Baby” until you press the “Admit Baby” key and start normal operation.

© 2007 General Electric Company, all rights reserved.

Control Modes The Giraffe Warmer has two control modes, Manual Mode and Baby Mode. In Manual Mode, the warmer controls radiant heater output from a heater power percentage setting that you enter using the control panel. In Baby Mode, the warmer controls radiant heater output based on temperature readings from a probe attached to the baby’s skin and a set temperature you enter using the control panel.

Manual Mode Screen

Step

Description

1

Manual Mode - Set heater power. After completing warm up and pushing the “Admit Baby” key, the warmer starts in the Manual Mode with a default 50% heater power setting. The percentage of full power can be adjusted in 5% increments using the increase/decrease keys on the left of the display. You can monitor the baby’s temperature with a skin probe in the Manual Mode, shown in the upper left corner of the display, but it does not control heater output. If you intend to use Manual Mode for a prolonged period time a skin probe should be attached to the baby.

WARNING: Do not leave baby unattended while the warmer is in Manual Mode. Whenever possible, use the warmer in the servo-control mode (Baby Mode). The Manual Mode requires constant monitoring of the baby’s condition by the caregiver.

Baby Mode Screen

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Step

Description

1

Baby Mode - Adjust set temperature. In the Baby Mode the warmer controls heater output to a desired baby set temperature (set temp) you enter. Heater output is based on measured differences between the set temperature and the skin probe temperature reading. You can enter desired set temperatures from 34 to 37.5 °C using the increase/decrease keys on the left of the display, and this value is shown above the power indicator bar graph in white numerals slightly smaller than the baby’s actual temperature. Baby temperature is shown in green in the upper left corner of the display.

© 2007 General Electric Company, all rights reserved.

1-7

On Screen Help Screen

Step

1

Description Pushing the “Help” (?) key brings up Help screen that provides information about alarms and functions. When an alarm sounds, pushing the “Help” key automatically displays information about that alarm.

The help screen main menu contains three sections: 1. “Operating Modes” (see Step 2, below,) 2. “Functions” (see Step 3, below), and 3. “Alarms” (see Step 4, below).

2

“Operating Modes” Pushing “Options” brings up information on the warmer modes such as Baby Mode, etc.

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Screen

Description

Step

3

“Functions” Pushing “Functions” brings up information on the warmer features such as Timer, etc.

4

“Alarms” Pushing “Alarms” brings up information on alarms.

5

Pushing “About” brings up information on the current software revision. Pushing “Exit” brings up the Home Screen.

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1-9

Home Screen Screen

Step

Description

1

Mode Current mode setting, “Manual” or “Baby” mode, is highlighted in blue on the left side of screen.

2

Timer Push the “Timer On/Off” key to start the timer and continuously display time elapsed. Push the “Timer On/Off” key a second time to end the timer.

3

Menu Push the “Menu” key to access the “Callback Timer”, “Scale”, “Trends”, “SpO2” and “Setup” keys. Note: If the Scale or SpO2 options are not installed on your unit, these keys will not appear on the display.

1-10

Giraffe Warmer

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© 2007 General Electric Company, all rights reserved.