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C-1

Panda iRes Warmer

M1110737 006

Appendix C

Electromagnetic Compatibility

__________________________________________

Electromagnetic compatibility (EMC) guidance

Safety Standards:

IEC 60601-1, IEC 60601-2-19 and IEC 60601-2-21,

EMC Standards:

IEC 60601-1-2 2nd ed.

WARNING:

Medical Electrical Equipment needs special precautions regarding EMC and needs to be

installed and put into service according to the EMC information provided below.

WARNING:

Portable and mobile RF communication equipment can affect Medical Electrical Equipment.

Caution should be use when operating such device around Medical Electrical Equipment

WARNING:

This equipment/system is intended for use by healthcare professionals only.

This equipment/system may cause radio interference or may disrupt the operation of

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.

Electromagnetic Emissions

Emissions test

Compliance

Electromagnetic environment guidance

RF emissions

CISPR 11

Group 1

The Giraffe Warmer uses RF energy only for its internal

function. Therefore, its RF emissions are very low and

are not likely to cause any interference in nearby

electronic equipment.

RF emissions

CISPR 11

Class A

The Giraffe Warmer is suitable for use in all

establishments, other than domestic and those directly

connected to the public low voltage power supply

network that supplies buildings used for domestic

purposes.

Harmonic

emissions

IEC 61000-3-2

Class A

Voltage

fluctuations/

flicker emissions

IEC 61000-3-3

Complies

Содержание Panda iRes Warmer

Страница 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...

Страница 2: ...iscontinue 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 Monog...

Страница 3: ...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 Sta...

Страница 4: ...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 Operat...

Страница 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 r...

Страница 6: ...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 entangl...

Страница 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 manufactur...

Страница 9: ...escribes 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...

Страница 10: ...n and Maintenance Manual M1110734 SpO2 Masimo SET Option Operation and Maintenance Supplement M1110918 Resuscitation System Bag and Mask Option Operation and Maintenance Supplement M1110023 Resuscitat...

Страница 11: ...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 resusci...

Страница 12: ...ctions 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 Res...

Страница 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 cab...

Страница 14: ...ed 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...

Страница 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...

Страница 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 f...

Страница 17: ...aby 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 ti...

Страница 18: ...n 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...

Страница 19: ...ed 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 in...

Страница 20: ...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...

Страница 21: ...e 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...

Страница 22: ...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 Sp...

Страница 23: ...o 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 Pan...

Страница 24: ...ou 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...

Страница 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 silenc...

Страница 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...

Страница 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 alar...

Страница 28: ...s 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...

Страница 29: ...diant 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...

Страница 30: ...o 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 automatic...

Страница 31: ...aby 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 Ba...

Страница 33: ...ient 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 befor...

Страница 34: ...he 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...

Страница 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 eas...

Страница 36: ...spital 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 outle...

Страница 37: ...ual 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 temper...

Страница 38: ...nual 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 an...

Страница 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...

Страница 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 ra...

Страница 42: ...ng 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 bedsi...

Страница 43: ...iption 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 po...

Страница 44: ...ter 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...

Страница 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 Tem...

Страница 46: ...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 equipme...

Страница 47: ...erature 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 Se...

Страница 48: ...iant 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...

Страница 49: ...amps 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 temperatur...

Страница 50: ...ace 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...

Страница 51: ...es 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...

Страница 52: ...de 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 t...

Страница 53: ...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 p...

Страница 54: ...ghts 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...

Страница 55: ...e 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 us...

Страница 56: ...tration 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...

Страница 57: ...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 detail...

Страница 58: ...bjects 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 S...

Страница 59: ...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...

Страница 60: ...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 i...

Страница 61: ...ast 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 th...

Страница 62: ...eck 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 iRe...

Страница 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 sy...

Страница 64: ...rogram 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 pati...

Страница 65: ...s 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...

Страница 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...

Страница 68: ...spital 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 Alwa...

Страница 69: ...o 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...

Страница 70: ...cale 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...

Страница 71: ...n 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...

Страница 72: ...robe 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...

Страница 73: ...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 p...

Страница 75: ...lator 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 pr...

Страница 77: ...A 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 wit...

Страница 78: ...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 t...

Страница 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 ele...

Страница 80: ...nt 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...

Страница 81: ...ducted 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...

Страница 82: ...s 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 R...

Страница 83: ...mum 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...

Страница 85: ...ean 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 el...

Страница 87: ...nformity 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...

Страница 88: ...s 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 Increa...

Страница 90: ...na Hi tech Park No1 Huatuo Road Zhangjiang Hi tech Park Pudong Shanghai P R China 201203 GE 1 201203 Tel 8621 38777888 Fax 8621 38777402 Australia 1300 722 229 China 800 810 8188 India 1 800 425 7255...

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