GE Giraffe Operation And Maintenance Manual Download

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4-5

Panda iRes Warmer

M1110737 006

Cleaning Solutions

Cleaning solutions that may be used safely:

Generic Formulation

Maximum Concentration

Sodium Hypochlorite (bleach)

0.5% Aqueous Solution

Glutaraldehyde

Hydrogen Peroxide

Iodophor Solution

0.27%

Cavicide

100% spray

Do not use the following cleaners; they will damage the parts you are cleaning and are not

recommended:

• Isopropyl Alcohol (in concentrations greater than 15%)

• Quaternary Ammonium (such as Virex)

• Solvents (such as acetone)

CAUTION:

Use of cleaning/disinfecting solutions containing chemicals not listed above, i.e. alcohol,

acetone, etc., or chemicals in greater concentrations than those listed above, may damage

the probe.

Summary of Contents for Giraffe

Page 1: ...GE Healthcare Panda iRes Warmer Operation and Maintenance Manual Panda iRes Warmer Operation and Maintenance Manual English M1110737 006 2007 General Electric Company All rights reserved ...

Page 2: ...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 ...

Page 3: ...e 1 21 Chapter 2 System Setup and Checkout Procedures 2 1 Mechanical checks 2 1 Controller checks 2 4 Ancillary equipment checks 2 7 Chapter 3 Operating the Warmer 3 1 Basic Operating Procedure 3 1 Start up 3 3 Panda iRes 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 ...

Page 4: ...g other components 4 7 Appendix A General Use Items A 1 Ancillary Equipment A 1 General Use Equipment 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...

Page 5: ... 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 ...

Page 6: ...s general warnings cautions and Notes associated with the use of the Panda iRes 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 ...

Page 7: ... 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 For professional use only Equipment shall be ...

Page 9: ...describes the procedures to operate the Panda iRes Warmer Chapter 4 Maintenance and Cleaning provides information on performing maintenance and cleaning of the Panda iRes Warmer Appendix A General Use Items is a list of general use and ancillary items that may be used with the Panda iRes Warmer Appendix B Specifications provides information on power requirements and accessory outlets standards ope...

Page 10: ...on and Maintenance Manual M1110734 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 ...

Page 11: ...n 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 The Panda iRes Warmer includes Recessed heater dish D...

Page 12: ...ections Figure 2 Panda iRes Warmer front oblique view Feature number Description 1 Two dimmable observation lights 2 Aimable procedure light 3 Procedure light On Off switch 4 Color display screen 5 Resuscitation system optional 6 Bed with integrated scale 7 Front bedside panel 8 Bed tilt control lever 1 2 3 4 5 6 7 8 1 ...

Page 13: ... 10 Side bedside panel 11 Front handle 12 Pass trough drawer 13 Two bed height adjustment pedals up and down 14 Four caster wheels 15 Four brakes 16 Elevating column 17 Tank guard optional 18 Scale cable connector 19 Temperature probe Jack 20 High pressure air oxygen yoke optional 21 Maneuvering handle and cord wrap 22 Dovetail rail 9 14 12 13 15 16 10 11 17 18 19 20 21 22 ...

Page 14: ...ved 1 4 Mechanical Controls and Cable Connections continued Figure 4 Panda iRes Warmer rear view Feature number Description 23 RS 232 connector 24 Two accessory power outlets 25 SpO2 Jack 26 Removable rear bedside panel 27 Power cord inlet 28 Mains Power Switch 28 27 26 25 23 24 ...

Page 15: ... at all times 5 Baby temperature Can be displayed in degrees Celsius or degrees Fahrenheit The default setting is degrees Celsius 6 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 7 Help key The key with the in the upper right corner brings up the help screen that explains alarms and functions 8 Task keys ...

Page 16: ... Step Description 1 The Panda Warmer automatically starts in Warmup Mode During Warmup Mode Check Baby alarms are deactivated If you do not press the Admit Baby key or the APGAR On Off key during the first minutes after start up the display will show Warming and the radiant heater will automatically run at 100 power 2 After 7 minutes the display indicates War mup Complete and the default heater po...

Page 17: ...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 of 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 ...

Page 18: ...on about alarms and functions When an alarm sounds pushing the Help key automatically displays information about that alarm The help screen main menu contains four sections 1 Operating Modes see Step 2 below 2 Functions see Step 3 below 3 Alarms see Step 4 below and 4 About see step 5 below 2 Operating Modes Pushing Operating Modes brings up information on warmer modes such as Baby Mode etc ...

Page 19: ...ved Screen Step Description 3 Functions Pushing Functions brings up information on warmer features such as APGAR 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 ...

Page 20: ...R timer and continuously display time elapsed A tone will sound at 1 5 10 minutes and every five minutes thereafter to remind you to evaluate the baby s APGAR score A visual message will appear for the 1 5 and 10 minute APGAR times only Press the APGAR On Off key a second time to end the timer 3 Menu Push the Menu key to access the APGAR On Off Scale Trends SpO2 and Setup keys Note If the Scale or...

Page 21: ...he Menu key to access the Scale key If the scale jack is not plugged in the scale key will not appear Push the Scale soft key to start the weighing procedure and access the next menu For more detail on performing the weighing procedure and using the scale refer to Using the In Bed Scale optional on page 3 17 ...

Page 22: ...y set temperatures baby temperatures and heater output Push the Time Scale key to change the time period shown on the graph from the default 15 minutes to 30 minutes or 60 minutes SpO2 trending with SpO2 option installed Screen Step Description 1 Push the SpO2 key to view a graph that plots both the baby s blood oxygen saturation percentage and the baby s pulse rate Note the SpO2 key only appears ...

Page 23: ...to choose from 4 volume levels Push the SpO2 Pulse Tone Volume key to choose from 4 pulse tone volume levels and a tone off setting The default is On at low volume Push the Set Clock key to set the Panda iRes Warmer clock You can adjust the clock for time zone and seasonal variations Push the Next key to access a second setup menu 2 Push the Elevate key to enable and disable the bed elevating feat...

Page 24: ...you wish to manage the baby s temperature in the Manual Mode but want to be notified when the baby s temperature drops below or rises above a threshold setting Place the temperature probe on the baby s skin Push the Man Temp Alarm key to choose from 3 settings in the warmer s Manual Mode The default Off setting deactivates the alarm the 0 5 setting activates an alarm when the difference between th...

Page 25: ... 4 Alarm message To silence the alarm There are two methods of silencing the alarm 1 Press the yellow button at the top of the control panel 2 Use the Hands Free Alarm Silence see below When you silence an alarm the text message gets smaller and moves to the top of the screen and the red alarm light goes from blinking to solid When the alarms have been silenced the audio tone is temporarily turned...

Page 26: ... gently waving your hand approximately 2 6 inches in front of the sensor Silencing an alarm with the Hands Free Alarm Silence works exactly the same as pressing the alarm silence button for all alarms Using the Hands Free Alarm Silence will allow you to silence alarms without touching a panel surface WARNING Do not block the alarm speaker located on the back of the control panel near the power out...

Page 27: ... audio alarm for twelve 12 minutes When the baby s temperature is greater than 2 0 C above the Set Tempera ture a high priority alarm activates Silencing the alarm suspends the high priority audio alarm for five 5 minutes The low priority alarm setting can be nar rowed to 0 5 C using the Setup screen and Pt Temp Alarm keys Manual Mode The alarm can be activated in the Manual Mode using the Setup a...

Page 28: ...ys Manual Mode The alarm can be activated in the Manual Mode using the Setup and Man Temp Alarm key See Chapter 3 for detailed description Action monitor the baby carefully and check the attachment of the probe on the baby s skin Check Baby Screen Step Description 1 Baby Mode The low priority Check Baby alarm activates and an intermittent tone sounds after the radiant heater has been running at 10...

Page 29: ...adiant heater then shuts off automatically and the high priority Check Baby Heat Off alarm activates Action silence the alarm and check the attachment of the skin probe to the baby and monitor the baby s temperature closely Default power setting is 25 but this can be adjusted on the Service Screen Refer to the Service Manual Confirm Probe Jack Connection Screen Step Description 1 Baby Mode The Con...

Page 30: ...Do not use the warmer if the system failure alarm is activated Remove the unit from service and refer to qualified personnel for repair If an electrical failure is detected the system failure automatically shuts off the heater and triggers a two tone audio alarm that can not be silenced Action make note of the error message and remove unit from service Scale Alarms Screen Step Description 1 Weight...

Page 31: ...Baby alarm has gone unanswered for three minutes 15 min 15 min 1 1 Baby Mode Manual Mode Baby Cold Check Temp Probe 2 0 C from Set Temp 1 0 C 0 5 C from Set Temp 5 min 12 min 1 2 Baby Mode Baby Mode Baby Hot Check Temp Probe 2 0 C from Set Temp 1 0 C 0 5 C from Set Temp 5 min 12 min 1 2 Baby Mode Baby Mode Confirm Probe Jack Connection No longer getting a reading from the tem perature probe 2 min ...

Page 33: ...tient or user injury WARNING Do not perform the preoperational checkout procedure while the patient occupies the unit WARNING Complete the preoperational checkout procedure section of this manual before putting the unit into operation If the equipment fails any portion of the checkout procedure it must be removed from use and repaired Illustration Step Description 1 Disconnect the power cord for t...

Page 34: ...the power cord and the accessory outlets on the back of the control panel are in place 4 Examine the unit overall for any damaged or missing parts 5 Check that all the casters are in firm contact with the floor and that the unit is stable Lock the caster brakes and check that they hold the unit in place Release the brakes and check that the unit moves smoothly ...

Page 35: ... should lock securely in the upright position 7 Check the operation of the bed tilt mechanism When you squeeze the tilt control and push down on the foot of the bed the head of the bed should raise easily and should stay in position at any angle along its tilt path when you let go of the tilt control The bubble levels on the side bedside panels should indicate the mattress is level ...

Page 36: ...ospital grade wall outlet Connecting to a power strip or another piece of equipment may result in power failure errors Illustration Step Description 1 Make sure the power cord is connected to the outlet on the unit and to the rated power supply 2 Switch on the power at the mains switch on the back of the unit and at the standby switch on the front control panel Verify the following All the display...

Page 37: ...nual Mode Select Heater Power percentage to silence the prompt tone 4 Connect the baby temperature probe to the jack on the right side of the bed If using a Panda Warmer with an in bed scale the temperature probe jack is above the In bed scale connection 5 Check the skin probe Warm it by placing it between your fingers and verify that the baby temperature reading increases ...

Page 38: ...anual Mode by press ing the Mode key Select a Heater Power setting to silence the prompt tone 8 If the unit is equipped with an elevating bed check the operation of the bed elevation mechanism Raise and lower the bed along its entire travel range checking that the mechanism operates smoothly Check that the two bed height adjustment pedals on either side of the unit raise and lower the bed height N...

Page 39: ... the operation of any ancillary equipment with reference to their appropriate operation manuals 3 Setup any required suction or gas supply systems Check them for leaks as described in their respective operation manuals WARNING Do not place the warmer in a high ambient air flow environment WARNING Do not place the baby in the bed while in Warmup Mode Service Mode or while servicing or calibrating t...

Page 41: ... instruments that radiate electrical fields can cause indirect heating by several tenths of a degree of the skin temperature probe due to absorbed electrical energy When using these devices near the radiant warmer operate the warmer in Manual Mode for maximum safety and use a skin temperature probe to monitor patient temperature For added safety you should consider use of the manual temperature al...

Page 42: ...ing the need to monitor the patient and make adjustments to the Baby Mode control temperature WARNING Do not leave the baby unattended while any bedside panels are lowered or removed WARNING When bedside panels are in an upright position ensure that the bedside panels are properly locked in place WARNING The patient probe is not isolated from earth ground Any additional equipment used with the Pan...

Page 43: ...ription 1 Plug the unit into a properly rated AC power outlet and set the caster brakes 2 Place the mains power switch located by the outlets on the back of the unit in the On I position 3 Place the power Stand By switch located on the left side of the controller in the On I position Check the control panel to ensure the screen is working properly ...

Page 44: ...ater will automatically run at 100 power 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 5 Pressing the Admit Baby key or the Apgar On Off key brings the Panda Warmer to Manual Mode at 100 power An audible tone alerts the user to select a he...

Page 45: ... 8 For Baby Mode operation connect the skin temperature probe to the temperature probe jack In the Manual Mode use a probe if you wish to display the patient skin temperature See Attaching the Skin Temperature Probe later in this section 9 If Baby Mode is desired press the Mode key to toggle to Baby Mode Current mode setting Manual or Baby mode is highlighted in blue on the left side of screen ...

Page 46: ...7 006 2007 General Electric Company all rights reserved 3 6 Illustration Step Description 10 Select a temperature setting using the up or down temperature keys WARNING Do not connect unapproved equipment into accessory outlets ...

Page 47: ...perature probe is plugged into the probe jack Attach reusable or disposable skin temp probe must be on side of baby that faces heater dish and cover with reflective patch Press up or down to desired Set Temp level Press Mode soft key to change to Baby Mode Check Baby Alarm is active Alarm calls clinician to beside every 12 minutes Check Baby Alarm is inactive Attach reusable or disposable skin tem...

Page 48: ...diant heat 1 shows the heat reflective patch 2 shows a reusable patient temperature probe 3 shows a disposable patient temperature probe WARNING Do not place the probe between the baby and the mattress inaccurate readings will result WARNING Do not remove the reflective foil from the disposable probe or reflective patch Do not use a probe without a reflective patch Replace the patch when repositio...

Page 49: ...lamps the probe must be directly in the path of the radiant heat of the lamp do not place the probe in an area shielded from the lamp s light The photo therapy lamp may raise the baby s skin temperature WARNING Do not use rectal temperatures to control the baby s temperature WARNING Do not remove the probe from its storage bag until required for use Replace the probe if the cable or tip becomes da...

Page 50: ...lace the metal side of the probe against the baby s skin peel the paper backing from the adhesive side of the patch and place the patch over the probe with the reflective foil side up 3 Route the probe wire through the gaps at the corner of the bedside panels or through the one of the slots in the rear bedside panel 4 Plug the temperature probe into the jack NOTE The Panda iRes Warmer cannot diffe...

Page 51: ...oes in Baby Mode To activate the alarm in Manual Mode you must to take the following steps Screen Step Description 1 Insert the temperature probe into the probe jack 2 Attach the skin temperature probe onto the baby s skin 3 Press the Menu soft key on the right side of the control panel a Press the Setup soft key on the submenu b Press the Next soft key on the submenu c Press the Man Temp Alarm so...

Page 52: ...ode on the left side of the control panel Press the Mode key to change the warmer from Manual Mode to Baby Mode Note If in Baby Mode skip to Step 6 NOTE If in Baby Mode skip to Step 6 5 Enter the set temp that will serve as the Man Temp Alarm set point 6 Return to Manual Mode and adjust the heater power up or down to achieve the desired baby s skin temperature ...

Page 53: ...o raise a bedside panel swing it to the upright position then allow it to engage in the latched position 2 To remove a bedside panel lower the panel and hold it parallel with the floor Press the side panel release button arrow with one hand and remove the panel To replace a bedside panel insert the panel into the fixed end pin first Then press the side panel release button in with one hand place t...

Page 54: ...ights Use only the Panda iRes Warmer bedside panels on the Panda iRes Warmer Tilting the bed Illustration Step Description 1 The bed tilts twelve degrees to allow feet up or head up positioning of the baby The tilt release is located underneath the foot of the bed Grasp both the handle and metal release in one hand and squeeze Push down or lift up on the foot of the bed to the desired position Let...

Page 55: ...he unit is equipped with an elevating base the bed can be raised or lowered using the bed height pedals located on the legs on either side of the warmer The bed height can be adjusted low enough for use by a seated caregiver or can be raised high enough for procedures performed by standing caregivers Fixed height bed models can be adjusted by following the instructions found in the service manual ...

Page 56: ...stration Step Description 1 Two observation lights are located in the heater head on either side of the heater dish 1 The observation lights serve as general illumination of the bed surface and can be set to the desired light intensity using the observation light dimmer knob located on the lower right corner of the control panel Using the procedure light optional An optional aimable procedure ligh...

Page 57: ...s or Black Outs Per the UPS Specifications the Giraffe UPS provides power to the Panda iRes Warmer in situations where the product is disconnected from a wall receptacle For specifications and a detailed description of the installation procedure refer to the Giraffe UPS Installation Instructions provided with the UPS Using the In Bed Scale optional The Panda Warmer can be equipped with its own in ...

Page 58: ...objects should not lean against bedsides All leads I V tubes and ventilator tubes should be secured Blankets may be tucked under the mattress but must not be tucked under the weighing platform Screen Step Description 1 Press the Menu key then select the Scale key to bring up the scale menu If the scale is not connected no icon will appear 2 Select Weigh from the menu to initiate weighing ...

Page 59: ...s not level then level the bed by sighting the bubble level on the side bedside panel and using the bed tilt control lever If the bed is level proceed to the the next step 4 In order to zero the scale the display will prompt you to lift the baby by showing the Lift Baby icon while a tone sounds Lift the baby and any tubing or leads attached to the baby Make sure that arms legs blankets and clothin...

Page 60: ...e Baby icon appears on the screen Place the baby back down on the mattress while hold ing up any leads or tubes attached to the baby 7 The scale will now calculate the baby s weight which will appear in the display NOTE The scale weighs any object on the platform so if you replace the baby without holding up lead and tubes the weight of the leads and tubes will be included with the baby s weight ...

Page 61: ...last weighing sequence if the weight is in doubt NOTE The most likely cause for using Reweigh is failure to keep lines tubes and medical equipment clear of the mattress when placing the baby back on the mattress 9 Selecting Last weight will display the most recent weight value 10 Push the g oz key to toggle the weight dis play between grams default and ounces ...

Page 62: ...heck out and use instructions in the Bag and Mask Option Operation and Maintenance Supplement or the Resuscitation System T piece Option Operation and Maintenance Supplement depending on your Panda iRes Warmer s resuscitation equipment setup Mounting ancillary equipment WARNING Overloading the shelves and accessory rails can affect the stability of the unit Always try to evenly distribute the weig...

Page 63: ... to the rail system Mounting rail system components 1 Loosen the mounting screw on the mounting block 2 Place the mounting block in position on the rail 3 Tighten the mounting screw Release the rail system component by loosening the mounting screw 1 Mounting universal adapter plate The Universal adapter plate allows bottle slides and additional bracket to mount to the rail system 1 Loosen the two ...

Page 64: ...program should constantly verify connection to the warmer controller and check for updated data Using the Nurse Call System interface WARNING Remote monitoring does not replace the need for direct patient observation by qualified medical personnel WARNING If you connect the Nurse Call output to system which uses the normally open connection a disconnected Nurse Call cable will not trigger an alarm...

Page 65: ...ps Description 1 Complete the basic operating procedure in chapter 3 2 Verify proper operation of the Nurse Call station 3 Connect the Nurse Call connector to the warmer 4 Place the unit into Baby Mode and unplug the patient probe to trigger an alarm Verify that you also get an alarm at the Nurse Call station ...

Page 67: ... grease oxidize readily and in the presence of oxygen will burn violently Repair Policy Warranty repair and service should be performed by a GE Healthcare Service Representative or at the GE Healthcare Service and Distribution Center To contact a GE Healthcare Service Representative call the GE Healthcare Service Office listed on the back cover Do not use malfunctioning equipment including equipme...

Page 68: ...ospital and local regulations for required frequencies Every week Clean the warmer and disinfect as required or between each patient Service maintenance This schedule lists the minimum frequencies Always follow hospital and local regulations for required frequencies Annually Perform the electrical safety checks as described in the service manual Calibrate the scale as described in the service manu...

Page 69: ...to remove any cleaner residue WARNING Do not clean the radiant heating element inside the protective grid WARNING Disconnect the power cord before cleaning the warmer CAUTION Electronic devices in the microprocessor controller are susceptible to damage from discharges of static electricity These devices are adequately protected but can be damaged if the unit is disassembled beyond that recommended...

Page 70: ...scale if installed 11 Remove the clear Plexiglas plate and mattress from the bed 12 Remove scale 13 Remove x ray tray 14 Wipe down component parts of bed and chassis base with recommended cleaning solu tion per hospital infection control policy Rinse and dry 15 Reinstall chemically disinfected component parts in reverse order from breakdown steps 16 Chemically disinfect and dry control panel 17 Ch...

Page 71: ...en Peroxide 6 Iodophor Solution 0 27 Cavicide 100 spray Do not use the following cleaners they will damage the parts you are cleaning and are not recommended Isopropyl Alcohol in concentrations greater than 15 Quaternary Ammonium such as Virex Solvents such as acetone CAUTION Use of cleaning disinfecting solutions containing chemicals not listed above i e alcohol acetone etc or chemicals in greate...

Page 72: ...probe by grasping the plug at the panel Do not pull on the probe lead These precautions will prevent damage to the probe CAUTION Do not allow cleaning fluid to leak into probe and electrical connectors Equipment damage may occur Steps Description 1 Determine if the patient probe is disposable or reusable Reusable probes use a separate heat reflecting patch are gray and have a round metal disk at t...

Page 73: ...s Methods other then those detailed in this section may damage the unit Always be sure to wipe dry all cleaning agents after cleaning Apply the cleaning solutions with a clean cloth or sponge Dry the parts with a clean damp soft cloth to avoid scratches NOTE Do not soak parts in cleaning solutions Always wipe parts dry of all cleaning solutions Following these two recommendations will greatly exte...

Page 75: ...ilator Mounting Pole 0217 5357 800 General Use Equipment Part Number Panda Mattress 6600 2057 500 Disposable patient probe 10 6600 0873 700 Disposable patient probe 50 6600 0874 700 Reusable patient probe 6600 0875 700 Heat reflecting probe patch 50 0203 1980 300 Multipurpose Clip 6600 2150 500 Dovetail Rail Extension 6600 0852 800 GCX Mounting Arm 6600 0894 215 Instrument Shelf 6600 0513 801 Tubi...

Page 77: ...1A 240v 50 60 Hz Standards Designed to meet requirements of IEC 60601 2 21 with amendment 21 CFR CH 1 Section 1020 30 n IEC 60601 1 with amendment UL 60601 1 IEC 60601 1 2 with amendment BSEN 45501 with amendment CSA CAN C22 2 601 1 Operating Environment Temperature 18 to 30 C Humidity 5 to 75 Non condensing relative humidity Pressure 70 106 kPa Air Velocity up to 0 3 m sec Storage conditions Temp...

Page 78: ...t nominal voltage Weight scale Functional range 300 g to 8 kg Accuracy 10 g NOTE The warmer is designed to last at least 8 years in normal use when operated maintained and serviced in accordance with the instructions provided in both the Operations and Maintenance and Service Manuals Mechanical Specifications Height 193 218 cm Width 64 cm Depth 119 cm Weight 100 kg Mattress Size 66 x 48 x 2 cm Bed...

Page 79: ... nearby equipment It may be necessary to take mitigation measures such as re orienting or relocating the equipment system or shielding the location Manufacturer s guidance and declaration regarding electronic emissions The Giraffe warmer is intended for use in the electronic environment specified below The user of the Giraffe warmer should ensure that it is used in such an environment Electromagne...

Page 80: ...ent Surge IEC 61000 4 11 1kV differential Mode 2kV common mode line 1kV differential Mode 2kV common mode line Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 Ut 95 dip in Ut for 0 5 cycle 40 Ut 60 dip in Ut for 5 cycles 70 Ut 30 dip in Ut for 25 cycles 5 Ut 95 di...

Page 81: ...nducted RF IEC 61000 4 6 3 Vrms 150 KHz to 80 MHz 3V Recommended separation distance P 2 1 d Radiated RF can affect the accuracy of in bed scale readings However the in bed scale is not critical to the performance of the Giraffe warmer unit see Note 1 on page B 4 P 2 1 d 26 MHz to 800 MHz P 3 2 d 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according ...

Page 82: ...ss telephones and land mobile radios amateur radios AM and FM radio broadcasts and TV broadcasts cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Giraffe warmer unit is used exceeds the applicable RF compliance level a...

Page 83: ...imum output power of transmitter W Separation distance in meters m according to frequency of transmitter 150 kHz to 80 MHZ P 2 1 d 80 MHz to 800 MHz P 2 1 d 800 MHz to 2 5 GHz P 3 2 d 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 0 1 2 1 2 2 3 10 0 3 8 3 8 7 3 100 0 12 0 12 0 23 0 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be ...

Page 85: ...pean Council Directive 93 42 EEC Medical Device Directive when it is used in accordance with the instructions provided in the Operation and Maintenance Manual This symbol indicates that the waste of electrical and electronic equipment must not be disposed as an unsorted municipal waste and must be collected separately Please contact an authorized representative of the manufacturer for information ...

Page 87: ...onformity with the description thereof contained in this manual and accompanying labels and or inserts when assembled operated maintained and repaired in accordance with the instructions provided This Product must be checked periodically A defective Product should not be used Parts that are broken missing plainly worn distorted or contaminated should be replaced immediately Should such repair or r...

Page 88: ...ss No adjustment Cold by 0 05 C or less No adjustment Cold by 0 06 C to 0 14 C Increase by 1 Cold by 0 15 C to 0 24 C Increase by 5 Cold by 0 25 C to 0 34 C Increase by 10 Cold by 0 35 C or more Increase by 15 Specifications The product is designed to meet a life span of 8 years However with proper maintenance and repairs the service life can be extended as long as service parts are available The ...

Page 90: ...rk No1 Huatuo Road Zhangjiang Hi tech Park Pudong Shanghai P R China 201203 上海GE中国科技园地址中国上海市浦东张江高科技园华佗路1号 201203 Tel 8621 38777888 Fax 8621 38777402 Australia 1300 722 229 China 800 810 8188 India 1 800 425 7255 Korea 02 1544 4564 South Eastern Asia 65 6277 3444 Brazil Only GE Healthcare Clinical Sytems Equipamentos Médicos Ltda Av Paulista 37 13º andar CEP 01311 902 Cerqueira César São Paulo SP...

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