A750i Operators Manual Rev B

A750 A 0i In nfant Tran nsport Inc cuba ator S Syste em with Optiionall PullseOx x perattor’s Man nual Op    

Ph hone: (51 12) 873-00 033 Fa ax: (512) 873-9090 0 E-M Mail: salles@int-b bio.com We ebsite: http://www h w.int-bio..com

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Ma ailing add dress: Intternational Biome edical 82 206 Cross s Park Dr. r. Au ustin, TX 78754 US SA

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Au uthorized d represen ntative in n Europe for Regu ulatory Afffairs: Em mergo Eu urope Prrinsesseg gracht 20 25 514 AP Th he Hague,, The Nettherlands s

TABLE OF CONTENTS SECTION 1: GENERAL INFORMATION ... 3 INTRODUCTION ... 3 CLASSIFICATION ... 3 SAFETY SUMMARY ... 4 IMPORTANT SAFETY CONSIDERATIONS ... 4 SYMBOLS ... 9 SECTION 2: OPERATING INSTRUCTIONS ... 10 FRONT PANEL DISPLAY FEATURES ... 10 SIDE PANEL FEATURES ... 15 POWER FEATURES ... 16 POWERING UP THE INCUBATOR ... 18 POWERING OFF THE INCUBATOR ... 18 DISPLAY MODES ... 19 TEMPERATURE CONTROL... 19 SETTING THE INFANT CHAMBER AIR TEMPERATURE ... 19 PULSE OXIMETER AND OXYGEN MONITOR CONTROL (OPTIONAL FEATURE) ... 20 ALARMS / INDICATORS ... 20 EXTERNAL LIGHTING ... 23 SKIN TEMPERATURE PROBE ... 23 SECTION 3: PULSE OXIMETRY (OPTIONAL FEATURE) ... 24 PULSE OXIMETER PRINCIPLES OF OPERATION ... 24 PULSE OXIMETER SET-UP INSTRUCTIONS ... 26 INITIAL SET-UP ... 26 SETTING HIGH AND LOW %SpO2 ALARMS ... 26 SETTING HIGH AND LOW PULSE RATE ALARMS ... 27 SETTING THE ALGORITHM MODE (MASIMO ONLY) ... 27 SETTING THE AVERAGING MODE (MASIMO ONLY) ... 28 SETTING THE PERFUSION INDEX (MASIMO ONLY) ... 29 OPERATIONAL ALARMS AND WARNINGS... 29 TEST OF OPERATIONAL ALARMS ... 31 PULSE OXIMETRY SENSORS ... 31 PULSE OXIMETRY TESTERS / SIMULATORS ... 32 SECTION 4: OXYGEN MONITOR (OPTIONAL FEATURE) ... 33 OXYGEN MONITOR PRINCIPLES OF OPERATION ... 33 OXYGEN MONITOR SET-UP INSTRUCTIONS ... 34 INITIAL SET-UP ... 34 SETTING HIGH AND LOW OXYGEN ALARMS ... 34 OXYGEN MONITOR CALIBRATION ... 35 OPERATIONAL ALARMS AND WARNINGS... 36 TEST OF OPERATIONAL ALARMS ... 36 Part No. 715-0079, Rev. B

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TABLE OF CONTENTS OXYGEN SENSOR ... 37 SECTION 5: PREVENTATIVE MAINTENANCE ... 38 DAILY MAINTENANCE ... 38 OPERATIONAL CHECK ... 38 AIR / OXYGEN SYSTEM ... 39 INFANT CHAMBER CHECK ... 40 CART AND ACCESSORIES ... 40 SENSORS AND CABLES (OPTIONAL EQUIPMENT) ... 40 CLEANING OF INCUBATOR AND CHAMBER ... 41 CLEANING OF CABLES (OPTIONAL EQUIPMENT) ... 41 CLEANING OF PULSE OXIMETRY SENSOR (OPTIONAL EQUIPMENT) ... 41 CLEANING OF OXYGEN SENSOR (OPTIONAL EQUIPMENT) ... 41 MONTHLY MAINTENANCE ... 42 BATTERY CARE ... 42 PRODUCT DISPOSAL / RECYCLING ... 42 SECTION 6: TROUBLESHOOTING ... 43 GENERAL TROUBLESHOOTING ... 43 MAIN DISPLAY ERROR CODES ... 44 PULSE OXIMETER AND OXYGEN MONITOR FAILURE CODES (OPTIONAL FEATURE) .. 44 SECTION 7: SPECIFICATIONS ... 47 ESSENTIAL PERFORMANCE ... 47 GENERAL MECHANICAL SPECIFICATIONS ... 47 ELECTRICAL SPECIFICATIONS ... 48 EMC SPECIFICATIONS... 49 OPERATIONAL SPECIFICATIONS ... 49 PULSE OXIMETER SPECIFICATIONS (OPTIONAL FEATURE) ... 49 OXYGEN MONITOR SPECIFICATIONS (OPTIONAL FEATURE) ... 51 OPERATING, STORAGE, AND TRANSPORT ENVIRONMENT ... 52 SECTION 8: WARRANTY ... 53 SECTION 9: SYSTEM DOCUMENTATION ... 54 EUROPEAN REGULATORY AFFAIRS REPRESENTATIVE ... 54 PARTS AND ACCESSORIES... 54

Part No. 715-0079, Rev. B

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SECTION 1: GENERAL INFORMATION INTRODUCTION The International Biomedical Model A750i Infant Transport Incubator with optional PulseOx (referred to herein as the incubator) provides a thermally regulated environment to support an infant’s temperature requirements and has the capability to monitor vital information during transport. The pulse oximeter and oxygen monitor measure pulse rate, oxygen saturation, and oxygen concentration and allow the user to configure high and low alarm settings. The incubator circulates warmed air throughout the infant chamber to maintain the temperature at a user-selected setpoint. Chamber doors and hand ports provide quick and easy access to the infant. Positioning straps are provided to limit infant movement within the infant chamber. There are no known contraindications associated with the incubator. NOTE:

The Pulse oximetry and oxygen monitoring is only available if the PulseOx version of the incubator was purchased.

This operator’s manual is designed to introduce the user to key features of the incubator, including safety issues, instructions for use, equipment maintenance and contact information. The manual should be read and understood by all users before using the transport incubator. Additional information may also be found in the service manual for the incubator.

CLASSIFICATION According to the standard EN60601-1 of the International Electrotechnical Commission, Medical electrical equipment, Part 1: General requirements for safety, the infant transport incubator is classified as follows: 

Class I / Internally Powered, according to the type of protection against electric shock

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Type B, according to the degree of protection against electric shock (i.e. the patient may not be electrically isolated from earth)

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Ordinary, according to the degree of protection against harmful ingress of water

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Equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitric oxide.

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Continuous operation for the mode of operation

The pulse oximeter cables and sensors are classified as type BF, per the EN60601-1 electrical standard. The skin temperature probe is classified as type BF, per EN60601-1 electrical standard (systems with optional PulseOx). The skin temperature probe is classified as type B, per EN60601-1 electrical standard (systems without optional PulseOx). Part No. 715-0079, Rev. B

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SECTION 1: GENERAL INFORMATION SAFETY SUMMARY The incubator is designed to be used by trained clinical users and/or biomedical engineers and operated in a manner consistent with the instructions contained in this manual. Refer to any additional training, procedures, requirements, or documentation beyond those identified here for operation and policies required within the institution. All personnel operating the incubator must be familiar with the warnings and operating procedures contained in this manual. International Biomedical is not to be held responsible if the incubator is used in a manner inconsistent with the instructions herein.

IMPORTANT SAFETY CONSIDERATIONS The incubator has been tested and found to comply with limits for electromagnetic interference and susceptibility as defined by EN60601-1-2. However, this equipment can radiate radio frequency (RF) energy and may cause harmful interference to other devices. The incubator may also be affected by interference from other devices. If RF interference is suspected, relocate or shield the incubator to reduce or eliminate the effects. Within certain governmental jurisdictions, all interconnected accessory equipment must be labeled by an approved testing laboratory. After interconnection with accessory equipment, risk (leakage) current and grounding requirements must be maintained. Safety concerns or additional pertinent information will be displayed using warnings, cautions, and notes, having the following significance: WARNING:

Maintenance or operating procedure, technique, etc., which may result in personal injury or loss of life if not carefully followed.

CAUTION:

Maintenance or operating procedure, technique, etc., which may result in patient harm or damage to equipment if not carefully followed.

NOTE:

Maintenance or operating procedure, technique, etc., which is considered essential to emphasize.

The principal WARNING and CAUTION notices to be observed in use of this incubator are brought together here for emphasis.

Part No. 715-0079, Rev. B

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SECTION 1: GENERAL INFORMATION WARNINGS 

OBSERVE BEST PRACTICE: The instructions in this manual in no way supersede established medical procedures or staff preference concerning patient care.

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ENSURE UNIT IS PROPERLY GROUNDED: To ensure grounding reliability, only connect the power cord to a properly grounded, 3-wire hospital grade outlet of the proper voltage and frequency. DO NOT USE EXTENSION CORDS. If the integrity of the connection is in doubt, the incubator should be operated from its internal battery.

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EXPLOSION HAZARD: Do not use the examination light, the pulse oximeter, or oxygen monitor in the presence of flammable anesthetics or other flammable gases.

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USE OF OXYGEN INCREASES FIRE DANGER: Spark-producing auxiliary equipment should not be placed in or near the transport incubator.

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Avoid direct sunlight or radiant heat, which can cause a dangerous increase in chamber air temperature.

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Avoid eye exposure. Direct light exposure may cause eye damage. Infants must wear eye protection.

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The use of oxygen may increase the noise level within the infant chamber.

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Air and oxygen tanks are pressurized and must be properly secured.

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The transport incubator is Type B equipment and the baby may not be electrically isolated from earth. Care must be taken that additional equipment connected to the baby is electrically safe. To ensure patient electrical isolation, connect only to other equipment with electronically isolated circuits.

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Do not change the lamp and touch the patient simultaneously.

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When the infant tray is removed, do not touch exposed circuitry and patient simultaneously.

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This incubator was calibrated with the infant chamber originally supplied. If this chamber is exchanged for an infant chamber of a different configuration or size, the temperature calibration will be affected. Consult International Biomedical before returning the incubator to service.

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The incubator should be turned off and AC or DC power disconnected when cleaning.

Part No. 715-0079, Rev. B

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SECTION 1: GENERAL INFORMATION 

The use of devices which radiate high intensity electrical fields may affect the operation of the transport incubator. Constant assessment of the patient and all life support equipment is mandatory whenever interfering devices are operating on or near patient.

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When using the transport incubator adjacent to or stacked with other equipment, observe the operation of the transport incubator and the other equipment to ensure normal operation.

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Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer then 30 cm to any part of the transport incubator and associated cables. Otherwise, degradation of the performance of this equipment could occur.

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When the incubator is attached to a Ferno 146 Collapsible Cart, the two highest positions should not be used as they can cause a tip hazard.

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Do not use the pulse oximeter or oximetry sensors during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. The pulse oximeter may affect the MRI image and the MRI unit may affect the accuracy of the oximetry results.

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If using pulse oximetry during full body irradiation, keep the sensor out of the irradiation field. If the sensor is exposed to irradiation, the reading might be inaccurate or the unit might read zero for the duration of the active irradiation period.

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The pulse oximeter should NOT be used as an apnea monitor.

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If an alarm condition (other than exceptions listed herein) occurs while the MUTE button is activated, only visual alarm indicators will be activated.

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Pulse rate measurement is based on the optical detection of a peripheral flow pulse and therefore may not detect arrhythmias. The pulse oximeter should not be used as a replacement or substitute for ECG based arrhythmia analysis.

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Connecting equipment to the outlets on this device creates a medical electrical system and the user is responsible for continued compliance with the requirements of IEC 60601-1.

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Do not modify this equipment without proper authorization from International Biomedical.

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An Infant Transport Incubator should be used by appropriately trained personnel and under the direction of qualified medical staff familiar with currently known risks and benefits of Infant Transport Incubator use.

Part No. 715-0079, Rev. B

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SECTION 1: GENERAL INFORMATION 

When this incubator is operated on battery in low ambient temperatures, the thermal cover must be used.

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Skin temperature probe is not a rectal probe. The skin temperature sensor is not to be used as a rectal probe.

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Do not use liquids in or around the transport incubator.

CAUTIONS 

U. S. Federal and Canadian law restricts this device to sale by or on the order of a physician or other licensed medical practitioner. Outside Canada and the U. S., check with local laws for applicable restrictions.

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Use of sharp objects on Front Display Panel will cause permanent damage and will void warranty.

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Do not touch, press, or rub the display panels with abrasive cleaning compounds, instruments, brushes, rough-surface materials, or bring them into contact with anything that could scratch the panel.

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Use an oxygen analyzer when oxygen is delivered to the infant.

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The incubator electronics contain static sensitive components that can be damaged by improper handling. Use approved grounding techniques for work areas and service personnel.

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The infant tray grounding tabs are sharp; use care when cleaning air flow system.

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Do not move the incubator by pushing on the infant chamber. The infant chamber is not designed to sustain the forces to push the incubator. Stress fractures in the infant chamber can occur.

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DO NOT leave the 12 volt cord attached to the DC connector of the incubator.

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Do not overtighten the infant chamber screws. Do not strip the aluminum into which these screws are threaded.

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Do not drip cleaning solution through the holes where the swell latches fit into the air flow assembly.

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The incubator MUST be plugged into AC power and the battery recharged after any battery usage. The battery will sustain damage if drained of power and not placed on recharge soon.

Part No. 715-0079, Rev. B

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SECTION 1: GENERAL INFORMATION 

CLEANING AND CARE: Do not autoclave, pressure sterilize, or gas sterilize the incubator, cables, or sensors. Use cleaning solutions sparingly as excessive solution can flow into the incubator and cause damage to internal components. Do not soak or immerse the incubator or sensors in any liquid. Do not use petroleum-based, alcohol, acetone, or other harsh solvents. See cleaning instructions of reusable sensors and cables in directions for their use.

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Check alarm limits each time the system is used to ensure that they are appropriate for the patient being monitored.

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Use only parts, accessories, transducers, and cables designated by International Biomedical for use with the transport incubator. Cables and accessories other than those supplied by International Biomedical may result in unacceptable operation of the transport incubator and will void the equipment warranty.

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If a sensor or cable is damaged in any way, discontinue use immediately.

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The Maxtec MAX-250E oxygen sensor is a sealed device containing a mild acid electrolyte, lead (Pb), and lead acetate. Lead and lead acetate are hazardous waste constituents and should be disposed of properly, or returned to Maxtec or International Biomedical for proper disposal or recovery.

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Pulse oximeter probes and cables are designed for use with specific monitors. Only use Masimo sensors and patient cables for Masimo pulse oximetry model. Only use Nellcor sensors and patient cables for Nellcor pulse oximetry model. Verify the compatibility of the monitor, sensor, and cable before use, otherwise patient injury can result.

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Only use International Biomedical cable and Maxtec sensor for oxygen monitoring.

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Calibrate the oxygen sensor daily when in use or if environmental conditions change significantly (i.e., Temperature, Humidity or Barometric Pressure).

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Dropping or severely jarring the oxygen sensor after calibration may shift the calibration point enough to require recalibration.

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Oxygen sensor and pulse oximetry cables must be contained within cart or otherwise secured when not in use.

Part No. 715-0079, Rev. B

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SECTION N 1: GE ENERA AL INFO ORMAT TION SY YMBOL LS Th he following g symbols appear a in th he incubatorr documenttation and labels. The ese internattionally reccognized sy ymbols are defined by y the Interna ational Elecctrotechnica al Commisssion, IEC 417A and IE EC 87 78. On (power: connection to the mains) Off (Standby)

(Blue Background)

Atte ention, consult accompanyying documents Alte ernating Curre ent Dire ect Current Prottective earth (ground) Typ pe B equipment (EN60601--1) Typ pe BF equipment (EN60601 1-1) Rec cycle or dispo ose of properlyy, contains se ealed lead ba atteries

SYMBOL

MANUAL L REFERENC R CE

ALARM M

Designates locatiion of alarms on front pane el

HIGH H TEMP

High h temperature e alarm indica ator

SYS FA AIL

Systtem failure ala arm indicatorr

AIR FLO O

Air flow f blockage e alarm indica ator

SENS S FA AIL

Prim mary temperatture sensor m malfunction alarm indicatorr

PWR P FA AIL

Incu ubator not con nnected to AC C nor DC, and d battery pow wer is belo ow 10.1 volts

MUTE E BABY TEMP

Parrt No. 715-007 79, Rev. B

EXPLA ANATION

Mute e button silen nces audible a alarms for app proximately 1 minute Baby probe temp perature mode e

BAT CH HG AC OP P DC OP P

Battery charging indicator

BAT OP P

Incu ubator operati ng on interna al battery due to no externa al power conn nected

LOW BA AT

Low w battery indiccator

Incu ubator conneccted to AC po ower Incu ubator conneccted to DC po ower

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SECTION 2: OPERATING INSTRUCTIONS This section contains operating procedures for the incubator. The incubator should be operated with external power whenever possible. The incubator’s battery should be fully charged prior to use by connecting the unit to an AC power supply for at least 8 hours. When not in use, the incubator should be plugged into an AC power source in order to recharge the battery. It is not recommended for the incubator to be on and heating when not in use as this will shorten the life of system components. WARNING:

Avoid direct sunlight or radiant heat which can cause a dangerous increase in chamber air temperature.

FRONT PANEL DISPLAY FEATURES The incubator controls are located on a front display panel. Figure 2 - 1 shows a drawing of the membrane panel and highlights important features. A description of each of the features follows. CAUTION:

Use of sharp objects on Front Display Panel will cause permanent damage and will void warranty.

CAUTION:

Do not touch, press, or rub the display panels with abrasive cleaning compounds, instruments, brushes, rough-surface materials, or bring them into contact with anything that could scratch the panel.

Part No. 715-0079, Rev. B

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SECTION N 2: OP PERAT TING INSTRUC CTIONS S Figure F 2 - 1 Front Di splay Pane el

1. Syste em Fail Alarm Indicator (SYS S FAIL) 2. Senssor Fail Alarm IIndicator (SEN NS FAIL) 3. Air T Temperature Se etpoint >37 C Indicator 4. Air F Flow Alarm Indiicator (AIR FLO O) 5. High h Temperature Indicator (HIGH H TEMP) Fail Indicator 6. AC F er Fail Indicato 7. Powe or (PWR FAIL) 8. Main n Display Scree en 9. Air T Temperature Diisplay Indicatorr 10. Sett Air Temperatu ure Indicator 11. Bab by Temperature e Display Indiccator 12. Batttery Life Displa ay Indicator 13. Bab by Temp. Displlay Button (BA ABY TEMP) 14. Sett Air Temperatu ure Down Butto on 15. Sett Air Temperatu ure Button 16. Sett Air Temperatu ure Up Button 17. Mutte Button and IIndicator (MUT TE) * 18. Oxygen Saturatiion Display Scrreen ulse Rate Disp play Screen * 19. Pu * 20. Oxygen Display Screen * 21. Oxygen Sensor Cal. Indicator * 22. Pu ulse Strength Indicator * 23. Oxygen Setpoint Low Indicatorr * 24. Pu ulseOx SET Bu utton * 25. Pu ulseOx Up / Do own Arrows 26. Batttery Life Displa ay Button 27. Low w Battery Indica ator (LOW BAT T) 28. Battt. Charging Ind dicator (BAT CHG) 29. AC Power Indicato or (AC OP) 30. DC Power Indicattor (DC OP) 31. Batttery Power Ind dicator (BAT OP P) 32. Pow wer Button

* NOT TE:

Parrt No. 715-007 79, Rev. B

Ite ems 18 - 25 5 are featurres exclusivve to the Pu ulseOx verssion of the iincubator.

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SECTION 2: OPERATING INSTRUCTIONS 1: System Fail Alarm Indicator (SYS FAIL) Yellow LED indicator that illuminates when the displayed temperature exceeds 39.0 C 2: Sensor Fail Alarm Indicator (SENS FAIL) Yellow LED indicator that illuminates when the temperature being sensed by the primary temperature sensor is outside the normal temperature range of the incubator (10 - 45 C) 3: Air Temperature Setpoint > 37 C Indicator Yellow LED that illuminates when the chamber air temperature setpoint is set above 37 C 4: Air Flow Alarm Indicator (AIR FLO) Yellow LED indicator that illuminates when the air flow is blocked 5: High Temperature Alarm Indicator (HIGH TEMP) Yellow LED indicator that illuminates when the displayed temperature exceeds 38.5 C 6: AC Fail Indicator Yellow LED indicator that illuminates when the incubator is unplugged from an AC power source 7: Power Fail Indicator (PWR FAIL) Yellow LED indicator that illuminates when the incubator is unplugged from AC and DC power and the internal battery voltage falls below 10.1 volts 8: Main Display Screen Seven segment digital display that displays chamber air temperature, baby temperature, battery life status, and HI or LO temperature alarms 9: Air Temperature Display Indicator Indicator is illuminated when the Main Display Screen displays the current air temperature in the infant chamber. 10: Set Air Temperature Indicator Indicator is illuminated when the user is adjusting the infant chamber air temperature set point. 11: Baby Temperature Display Indicator Indicator is illuminated when the BABY TEMP button is pressed and held.

Part No. 715-0079, Rev. B

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SECTION 2: OPERATING INSTRUCTIONS 12: Battery Life Display Indicator Indicator is illuminated when the Battery Life Display button is pressed and held. 13: Baby Temperature Button (BABY TEMP) When button is pressed, the Main Display Screen will display the temperature measured by the baby temperature probe. 14: Set Air Temperature Down Button Button will decrease the setpoint temperature in 0.1 C increments. 15: Set Air Temperature Button When button is pressed, the infant chamber air temperature can be adjusted. 16: Set Air Temperature Up Button Button will increase the setpoint temperature in 0.1 C increments. 17: Mute Button (MUTE) Button is used to silence audible alarms for approximately one minute. The warning LED to the left of the Mute Button will be illuminated for the duration of the mute cycle. NOTE:

The LED is only available with the PulseOx version of the incubator.

18: Oxygen Saturation Display Screen (Optional Feature) Screen displays functional oxygen saturation (units: percent). 19: Pulse Rate Display Screen (Optional Feature) Screen displays pulse rate (units: beats per minute). 20: Oxygen Display Screen (Optional Feature) Screen displays the oxygen concentration (units: percent). 21: Oxygen Sensor Cal. Indicator (Optional Feature) Indicator is illuminated when the user is calibrating the oxygen sensor. 22: Pulse Strength Indicator (Optional Feature) Bar graph will illuminate at the rate shown on the Pulse Rate Display Screen with a calculated intensity.

Part No. 715-0079, Rev. B

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SECTION 2: OPERATING INSTRUCTIONS 23: Oxygen Setpoint Low Indicator (Optional Feature) Indicator is illuminated when the oxygen concentration lower alarm limit is set to a value below 21%. 24: PulseOx SET Button (Optional Feature) Button used to enter modes to set pulse oximetry and oxygen monitor alarm limits and to calibrate the oxygen sensor 25: PulseOx Up and Down Arrows (Optional Feature) Buttons used to set pulse oximetry and oxygen monitoring variables 26: Battery Life Display Button Button used to display the status of the battery on the Main Display Screen 27: Low Battery Indicator (LOW BAT) Yellow LED indicator that illuminates when the battery voltage is less than 11 volts 28: Battery Charging Indicator (BAT CHG) Green LED indicator that illuminates when the battery is actively being charged 29: AC Power Indicator (AC OP) Green LED indicator that illuminates when the incubator is on and connected to external AC power 30: DC Power Indicator (DC OP) Green LED indicator that illuminates when the incubator is on and connected to external DC power 31: Battery Power Indicator (BAT OP) Green LED indicator that illuminates when the incubator is on and no external power is applied, indicating the unit is operating off of internal battery power 32: Power Button Button is used to turn the incubator on and off. When turned on, it enables the temperature display, pulse oximetry and oxygen monitor displays, alarms, and infant chamber air temperature control.

Part No. 715-0079, Rev. B

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SECTION N 2: OP PERAT TING INSTRUC CTIONS S SIDE PA ANEL FE EATURES Th he side panel of the inc cubator is where w the power p cordss, sensors, and probess connect, and where cirrcuit breake ers are loca ated. Figure e 2 - 2 show ws a drawin ng of the sid de panel an nd highlightts important fea atures. A description d of o each of the t features s follows. Figure e 2 - 2 Side e Panel 5 6

7

1

4

2

8

9 10

3

*1 1. Oxygen Sensor S Con nnector *2 2. Pulse Ox ximeter Sen nsor Connector 3 3. Baby Tem mperature Cable C Conn nector 4 4. Power Co ord Holder 5 5. DC Powe er Cord Con nnector * NOT TE:

6. P Potential Eq qualization S Stud 7. B Battery Circu uit Breakerr 8. E External Circcuit Breake er 9. A AC Circuit B Breakers 10. A AC Power Cord Conn nector

Ite ems 1 & 2 are a features s exclusive to the PulsseOx versio on of the inccubator.

1: Oxygen Sensor Con nnector (Op ptional Fea ature) Co onnection point p for the e oxygen se ensor cable 2: Pulse Oximeter Sensor Conne ector (Optio onal Featu ure) Co onnection point p for the e pulse oxim meter senso or cable (Ma asimo or Nellcor) 3: Baby Tem mperature Cable C Conn nector Co onnection point p for the e baby temp perature pro obe cable 4: Power Cord Holder When not in use, u power cord to be wrapped around a thesse holders

Parrt No. 715-007 79, Rev. B

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SECTION 2: OPERATING INSTRUCTIONS 5: DC Power Cord Connector Connection point for the DC power cord The individual conductors are labeled A (not used), B (negative), and C (positive). 6: Potential Equalization Stud This stud is used for potential equalization. 7: Battery Circuit Breaker 10 Amp circuit breaker connected to the battery circuit 8: External Circuit Breaker 10 Amp circuit breaker connected to the external DC input circuit 9: AC Circuit Breakers 3 Amp circuit breakers connected to the AC input circuit 10: AC Power Cord Connector Connection point for the AC power cord

POWER FEATURES The incubator can be operated in one of three power modes: external AC power, external DC power, or internal battery power. AC Power Mode AC power can be supplied using either 120 V or 230 V external AC power, depending on the incubator configuration. When operating in AC power mode, the AC OP indicator (Figure 2 - 1, item 29) will be illuminated. AC power has priority over all other power sources, external or internal. AC power should be used for warming the incubator in preparation for transport and must be used to recharge the battery. WARNING:

ENSURE UNIT IS PROPERLY GROUNDED: To ensure grounding reliability, only connect the power cord to properly grounded, 3-wire hospital grade outlet of the proper voltage and frequency. DO NOT USE EXTENSION CORDS. If the integrity of the available external power sources is in doubt, the incubator should be operated from its internal battery.

Part No. 715-0079, Rev. B

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SECTION 2: OPERATING INSTRUCTIONS DC Power Mode DC power can be supplied using a 12 V power source. When operating in DC power mode, the DC OP indicator (Figure 2 - 1, item 30) will be illuminated. External DC power is supplied through a 3 conductor circular connector located on the back of the incubator (Figure 2 - 2, item 5). DC power has priority over internal battery power. While operating in DC power mode, the battery will not be charged. Battery Power Mode Battery power will automatically be selected when neither AC power nor DC power are available. When operating on internal battery, the BAT OP indicator (Figure 2 - 1, item 31) will be illuminated. Connecting AC or DC power will supersede battery power operation. The battery charger operates continually when the incubator is connected to an AC power source. When charging, the green BAT CHG indicator (Figure 2 - 1, item 28) will be illuminated. The rate at which the battery charges decreases when the incubator is powered on. A significantly low AC line voltage will also decrease the rate of battery charge. It takes approximately 8 hours to fully charge a completely discharged standard 26 ampere-hour battery when the incubator is supplied AC power and is powered down. If the incubator is on and warming up, the battery charge time is two to three times longer. The incubator will maintain an infant chamber temperature of 37 C for three hours on a fully charged battery with an ambient temperature of 20 C. NOTE:

When not in use, the incubator should be plugged into an AC source to recharge the battery. See SECTION 5 on BATTERY CARE.

To determine how much battery life is left, the Battery Life Display Button (Figure 2 - 1, item 26) can be pressed to display the status of the battery on the Main Display Screen (Figure 2 - 1, item 8). In this mode, the Battery Life Display Indicator (Figure 2 - 1, item 12) will be illuminated. When operating on AC power, the Main Display Screen will indicate the state of charge of the battery as an estimated percentage (to the nearest 20%). A fully charged battery will display 100% and a battery which has almost reached its safe discharge level will display 0%. When the incubator is operating from battery power or external DC power, the Main Display Screen will indicate the battery voltage (to the nearest 0.3 volt). Regardless of the power source, error code E03 will be reported if the battery voltage is outside of the 9.0 volt to 14.5 volt range. To continue normal operation, the battery voltage must be above 10  0.3 volts. For general operation, the use of external AC or DC power is HIGHLY RECOMMENDED. The internal battery should be used only when the incubator has no other energy source available. Part No. 715-0079, Rev. B

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SECTION 2: OPERATING INSTRUCTIONS Power Interruption / Failure If external AC or DC power is lost while the incubator is powered on, the incubator will automatically switch over to battery power with no interruption in incubator performance or degradation of pulse oximeter and/or oxygen monitor accuracy. In the event of total power loss, all user-programmed settings (e.g. temperature setpoint, alarm limits) will default to the most recently programmed values.

POWERING UP THE INCUBATOR To turn the incubator on, press the Power Button (Figure 2 - 1, item 32) on the lower right hand corner of the Front Display Panel. When the incubator is turned on, all functional LEDs on the display panel will illuminate and the audible alarm will sound. This Power-up Indicator Test will last approximately two seconds after which the Main Display Screen will display the infant chamber air temperature set point. The PulseOx Display screen will alternately display the HI/LO alarm settings for 16 seconds. To interrupt the PulseOx display, press the PulseOx settings button. After the initial start-up, the PulseOx display will be in the “Off” status. After 5 seconds, if no buttons have been pressed, the display will change and show the actual measured infant chamber air temperature. The incubator will immediately attempt to regulate the infant chamber air temperature to the last set point stored in memory (refer to SECTION 2, SETTING THE INFANT CHAMBER AIR TEMPERATURE, for instructions on setting the temperature). One of three power source indicators will be illuminated, indicating which source is currently powering the incubator. 

AC power indicator (Figure 2 - 1, item 29)

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External DC power indicator (Figure 2 - 1, item 30)

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Internal battery power indicator (Figure 2 - 1, item 31)

POWERING OFF THE INCUBATOR To turn the incubator off, press the Power Button (Figure 2 - 1, item 32) on the lower right hand corner of the Front Display Panel. The Power Button provides the means of electrically isolating the incubator circuits from supply mains simultaneously on all poles.

Part No. 715-0079, Rev. B

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