Transport Incubator Model TI500 Operating Instructions Rev 8 Oct 2006

Table of Contents Section 1: Symbol Definition and Intended Use Symbol Definition... 1-1 Technical Definitions... 1-3 Intended Use... 1-4 Section 2: Introduction, Features, and Specifications Introduction... 2-1 System Overview... 2-1 Temperature Control... 2-2 Alarms... 2-2 Optional Equipment... 2-4 Specifications... 2-6 Physical Specifications... 2-6 Environmental Specifications... 2-7 Performance Specifications... 2-7 Electrical Specifications... 2-8 Temperature Specifications... 2-9 Regulations, Standards, and Codes... 2-9 Section 3: Precautions and Safety Tips Precautions... 3-1 Electrical Precautions... 3-3 Explosion Precautions... 3-3 Oxygen Precautions... 3-4 Electromagnetic Compatibility Precautions... 3-5 Section 4: Installation and Assembly Installation... 4-1 Assembly... 4-2 Connection to External Power Sources... 4-5 Installation of Oxygen Cylinders... 4-6 Transport Incubator (Model TI500) User Manual (67 990 70)

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General Operation and Functional Checkout...4-7 Section 5: Instructions for Use Instructions for Use...5-1 Controls, Indicators, and Connectors...5-1 Operation... 5-8 General Operation and Functional Checkout Procedure...5-8 Operation During Use... 5-16 Accessories...5-25 Adjustable Stand (Optional)...5-25 Shelf...5-26 Shelf Tie-Down Strap...5-26 Section 6: Cleaning, Maintenance, and Replacement Parts Cleaning...6-1 General Cleaning... 6-2 Steam Cleaning... 6-2 Cleaning Hard to Clean Spots... 6-2 Disinfecting...6-2 Sterilizing...6-3 Disassembling for Cleaning...6-3 Access Panel Cuffs...6-3 Mattress Tray... 6-4 Hood... 6-4 Upper Shell...6-4 Cleaning Procedures... 6-5 Lower Shell...6-5 Humidity Chamber and Upper Shell...6-5 Mattress Tray and Deck... 6-6 Hood and Accessory Adjustable Stand...6-6 Tubing Access Grommets...6-7

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Transport Incubator (Model TI500) User Manual (67 990 70)

Air Intake Filter... 6-7 Skin Temperature Probe... 6-7 Assembling After Cleaning... 6-7 Disposal... 6-10 Maintenance... 6-11 Battery... 6-12 Power Failure Alarm Battery... 6-12 Calibration and Preventive Maintenance... 6-13 Replacement Parts... 6-13 Section 7: Troubleshooting Troubleshooting... 7-1 Section 8: Storage and Handling Storage and Handling... 8-1

Transport Incubator (Model TI500) User Manual (67 990 70)

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Transport Incubator (Model TI500) User Manual (67 990 70)

Symbol Definition This manual contains different typefaces and icons designed to improve readability and increase understanding of its content. Note the following examples: • Standard text-used for regular information. • Boldface text-emphasizes a word or phrase. • NOTE:-sets apart special information or important instruction clarification. • The symbol below highlights a WARNING or CAUTION: Warning and Caution

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A WARNING identifies situations or actions that may affect patient or user safety. Disregarding a warning could result in patient or user injury.

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A CAUTION points out special procedures or precautions that personnel must follow to avoid equipment damage.

• The symbol below highlights a CAUGHT HAZARD WARNING: Caught Hazard Warning

• The symbol below highlights a CHEMICAL HAZARD WARNING: Chemical Hazard Warning

• The symbol below highlights an ELECTRICAL SHOCK HAZARD WARNING: Electrical Shock Hazard Warning

Transport Incubator (Model TI500) User Manual (67 990 70)

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SYMBOL DEFINITION INTENDED USE

Section 1 Symbol Definition and Intended Use

This product contains different icons designed to increase understanding. Note the following examples: • The symbol below indicates “Attention! Consult accompanying documents”: Attention! Consult Accompanying Documents

• The symbol below indicates “Type BF equipment with an F-type isolated (floating) applied part”: Type BF Equipment

• The symbol below indicates a BATTERY OPERATION INDICATOR: Battery Operation Indicator

• The symbol below indicates a POWER ON/OFF SWITCH: Power On/Off Switch

• The symbol below indicates a SET TEMPERATURE DOWN KEY: Set Temperature Down Key

• The symbol below indicates a SET TEMPERATURE UP KEY: Set Temperature Up Key

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Transport Incubator (Model TI500) User Manual (67 990 70)

SYMBOL DEFINITION INTENDED USE

• The symbol below indicates a SILENCE/RESET KEY: Silence/Reset Key

• The symbol below indicates “Electromagnetic interference:” Electromagnetic Interference

Technical Definitions • Setpoint-The incubator temperature selected for operation during use. • Incubator temperature-Air temperature at a point 10 cm (4") above and centered over the mattress surface. • Temperature equilibrium-The condition reached when the average incubator temperature does not vary more than 0.2°C (0.36°F) over a period of one hour. • Temperature overshoot-The amount by which the incubator temperature exceeds the average incubator temperature at temperature equilibrium when the setpoint is changed from 30°C (86°F) to 34°C (93.2°F). • Temperature rise time-The time required for the incubator temperature to rise to 34°C (93°F) from an ambient temperature of 23°C (73.4°F) with a 36°C (96.8°F) setpoint. • Temperature uniformity-The amount by which the average temperature at each of five points 10 cm (4") above the mattress surface differs from the average incubator temperature at temperature equilibrium. (The five points are the centers of five areas created by lines that divide the width and length of the mattress surface.) • Temperature variability-During steady temperature conditions, the incubator temperature (measured 10cm above center mattress) is within 1°C of the average incubator temperature.

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Intended Use This manual provides instructions for installation, use, operator maintenance, and troubleshooting of the transport incubator (Model TI500). Dräger Medical cannot be responsible for the performance and safety of the incubator if the user does not operate the unit in accordance with the instructions, fails to follow the maintenance recommendations, or makes any repairs with unauthorized components. Only qualified service personnel should perform calibration and repair. Additional technical information is available from the manufacturer upon request through your local distributor. All personnel who will be working with the unit should read, thoroughly understand, and have ready access to this manual. Store the manual with the incubator when not in use. If there is anything you do not understand, please contact your local representative for further information.

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Transport Incubator (Model TI500) User Manual (67 990 70)

Section 2 Introduction, Features, and Specifications

The transport incubator provides transport of high-risk, premature, low birth-weight, or critically ill newborns. It provides a means to control air temperature, oxygen concentrations, and relative humidity. A doublewalled hood permits full visibility and provides an effective thermal and sound barrier from the environment. Arm ports and door panels provide front and head access, and the mattress tray slides out of the head end for additional access to the newborn. Tubing access grommets are on both sides of the front access panel and at the head end (left) panel. An observation lamp is also included. The incubator is designed to operate from either a sine or square wave AC power source. In addition, the incubator can operate from an external 12V DC or 28V DC source or integral 12V DC batteries. Whenever the unit is connected to an AC voltage source and the main Power switch is set to the ON-1 position, the batteries automatically charge. A comprehensive visual and audible fault alarm system, with a test function to verify proper alarm operation, is included along with a Battery Status indicator.

System Overview A forced air circulating system controls temperature, humidity, and oxygen concentration. A motor-driven impeller draws a controlled amount of room air through the air/oxygen intake filter. Supplemental oxygen, introduced through the oxygen inlet connector on the left side of the unit (when viewed from the front of the unit), displaces a portion of room air to maintain the total gas intake (including oxygen) at the same level. Since the impeller/filter controls the amount of room air and the flow meter setting controls the amount of oxygen, a predictable oxygen concentration within the incubator can be attained. In addition to drawing fresh, filtered air into the incubator, the impeller recirculates at a much greater flow than that of the fresh gas inflow. The air is directed over the humidity sponge for humidification, when used. When the access panel of the hood is closed, the air enters the infant Transport Incubator (Model TI500) User Manual (67 990 70)

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INTRODUCTION FEATURES SPECIFICATIONS

Introduction

compartment up through the slots at the right end of the housing. After circulating within the infant compartment, the air is then circulated down the left end of the housing, past the temperature sensing probe, and back to the impeller. The transport incubator is designed to operate from one of three power sources. The three sources are used in the following order: If external AC is not available, the incubator switches to external DC. If that is not available, it switches to its internal batteries. The batteries can be charged only when the unit is operating from an AC source.

Temperature Control A temperature sensor, located in the recirculation air path, and a proportional control circuit, which determines the heater output required to maintain the desired incubator temperature, regulate the incubator temperature. The number of Heater indicators lit on the control panel indicate the relative amount of heat provided. The incubator temperature can be maintained from 21.5°C (70.7°F) to 38°C (100.4°F), as selected with the temperature controls on the control panel. The temperature, as sensed by a sensor located within the housing, is compared to the setpoint. Control circuitry, which proportions the heater output to maintain the setpoint, supplies the information from this sensor. The temperature is displayed on the front panel. The setpoint is preset to 36°C (96.8°F) ± 0.15°C, and, unless the setting is changed, the incubator heats to this temperature. The Set Temp controls on the control panel can change the setpoint to a prescribed temperature (see “Operation During Use” on page 5-16). An additional sensor within the housing serves as a backup to limit the incubator maximum air temperature to 39°C (102.2°F) ± 0.5°C. At this limit, the High Temperature alarm activates, and the heater shuts off.

Alarms Each time the unit turns on, it automatically activates a test sequence to verify that the visual display and audible alarms are functional. • High Temperature-A sensor located below the deck sounds this alarm when the incubator temperature is equal to or greater than 39°C (102.2°F) ± 0.5°C. A flashing High Temp indicator and a tone

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Transport Incubator (Model TI500) User Manual (67 990 70)

indicate a High Temperature alarm. Internally, the heater turns off. To silence this alarm for 5 min, press the Silence/Reset key.

• High Heater Temperature-The Heater Temperature indicator flashes along with an intermittent alarm to indicate that the heater temperature has exceeded 77°C (170.6°F). When this condition occurs, the heater and heater indicators turn off. To silence this alarm for 5 min, press the Silence/Reset key. • Airflow-The Airflow indicator flashes along with an intermittent alarm to indicate that the fan impeller has stopped rotating or is missing. When this condition occurs, the heater and heater indicators turn off. To silence this alarm for 5 min, press the Silence/Reset key. • Low DC-The Low DC indicator flashes, and an intermittent alarm sounds, to indicate that the incubator DC power source has fallen below a predetermined value. • Power failure-An internal battery that is separate from the battery powers the Power Failure alarm circuit. The alarm lights and a continuous tone sounds if AC power is lost and no external DC or internal battery is present. To silence this alarm for 5 min, press the Silence/Reset key. If the power source switches from AC to battery or external DC to battery, the Power Failure alarm lights, and an intermittent tone sounds. To reset the alarm, press the Silence/Reset key.

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INTRODUCTION FEATURES SPECIFICATIONS

• Sensor-Circuitry is provided to monitor the High Temperature alarm sensor for shorts or open condition. A flashing sensor indicator and an intermittent tone indicate a Sensor alarm. This alarm resets itself.

Optional Equipment

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Transport Incubator (Model TI500) User Manual (67 990 70)

Optional equipment available for use with the transport incubator is listed below. For part numbers for the accessories, refer to “Replacement Parts” on page 6-13. • IV pole INTRODUCTION FEATURES SPECIFICATIONS

• Accessory shelf • Pressure regulator and flow meter • DC power cord adapter • Adjustable stand • Second battery option The adjustable stands are designed to provide a convenient means of moving the transport incubator. Each stand is adjustable to different heights. They are designed to lock into the litter bar of an ambulance with a fastener such as a FERNO® Model 175 Series Cot Fastener System. 1

NOTE: The locking mechanisms vary with the ambulance or helicopter used.

1. Ferno® is a registered trademark of Ferno-Washington, Inc. Transport Incubator (Model TI500) User Manual (67 990 70)

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Specifications Specifications for the transport incubator are provided below. The use of infant seats, head hoods, or other accessories within the incubator can alter the air flow pattern and affect the following: • temperature uniformity • temperature variability • correlation of the incubator temperature reading to center mattress temperature • infant skin temperature All specifications are subject to change without notice.

Physical Specifications Feature

Dimension

Transport incubator and standard stand (Ferno-Washington stand, model 147A)

Nominal length Nominal width Nominal height (low hood) Nominal height (high hood) Nominal weight (including the incubator, adjustable stand, and one battery) Nominal weight (including the incubator, adjustable stand, and two batteries) Transport incubator Nominal length Nominal width Nominal height (low hood) Nominal height (high hood) Stands Nominal length

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102 cm (40") 56.5 cm (22.25") 111.8 cm (44") maximum, 81.3 cm (32") minimum 116.2 cm (45.75") maximum, 85.7 cm (33.75") minimum 72.1 kg (159 lb)

82.5 kg (181.9 lb)

95.9 cm (37.75") 52.7 cm (20.75") 50.8 cm (20.00") 55.2 cm (21.75") 102 cm (40.25")

Transport Incubator (Model TI500) User Manual (67 990 70)

Feature Nominal width Nominal height

Dimension

Environmental Specifications Feature

Dimension

Operating temperature range (ambient)

10°C (50°F) to 30°C (86°F) (incubator must be at least 3°C higher than the ambient.) -40°C (-40°F) to +70°C (158°F) ambient 0% to 95% RH, non-condensing Operating range: sea level to 3 km (10000 ft); non-pressurized ambient or sea level to 12 km (40000 ft); pressurized ambient Shipment range: sea level to 12km (40000 ft)

Storage temperature Relative Humidity Range Altitude

Performance Specifications Feature

Dimension

<20 cm/sec (39 ft/min) Mattress air velocity (average air and oxygen-flow rate circulated within the mattress area defined by five points up to a height of 4" above the mattress) Carbon dioxide (CO2) level Less than 0.5% when a 4% mixture of CO2 in the air is delivered at 750 ml within the hood (25 oz) per min at a point 10 cm (4") above the center of the mattress. Oxygen concentration Adjustable from a range of 21% to at least 58% with oxygen flow rates ≥ 6 LPM (1.6 gal/min). (Concentrations are achieved in less than 40 minutes at the corresponding oxygen flow.) Transport Incubator (Model TI500) User Manual (67 990 70)

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INTRODUCTION FEATURES SPECIFICATIONS

56.5 cm (22.25") 61.0 cm (24.00") - maximum, 30.5 cm (12.00") - minimum

Feature

Dimension

Noise level within the hood

Less than 60 dBa with ambient levels to ≤ 50 dBa 376.7 lx (35.0 fc) at 10 cm (4") above the center of the mattress ≤ 1°C

Observation light Correlation of the displayed incubator temperature to the actual incubator temperature at temperature equilibrium (see “Technical Definitions” on page 1-3).

Electrical Specifications Feature

Dimension

External power requirements 110V/120V AC, 50/60/400 Hz, 270W maximum sine or square wave or 220V/240V AC, 50/60/400 Hz, 270W maximum sine or square wave, 11V DC to 13V DC, 200W maximum, 26V DC to 30V DC, 200W maximum Internal battery type Lead acid, vented, rechargeable Internal battery voltage 12V DC nominal Internal battery quantity 1 (2 optional) Internal battery capacity 24 Amp hours per battery Internal battery charge time 10 hours per battery (from full discharge) Internal battery life expect200 complete charge/discharge cycles ancy Chassis leakage current 300µA or less (110V/120V AC units) 500µA or less (220V/240V AC units)

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Transport Incubator (Model TI500) User Manual (67 990 70)

Temperature Specifications Feature Operating temperature

Operating range (limited)

Relative humidity (RH) operating range Temperature setpoint range Temperature rise time Temperature variability Temperature overshoot Temperature uniformity

Maintains a differential of up to 25°C (45°F) between the ambient temperature and setpoint for 90 min per battery. Example: With a setpoint of 36°C (96.8°F) and ambient temperature of 11°C (51.8°F), the operating time (full heater, all heater lights on) is 90 min for one battery, or 3 hours for two batteries. 10°C (50°F) to 30°C (86°F) The incubator setpoint must be at least 3.0°C (5.4°F) higher than the ambient temperature. 0°C (32°F) to 30°C (86°F) At more extreme ambient temperatures, the incubator temperature may not be maintained due to extreme ambient temperatures. 0% to 95% RH non-condensing, IEC class I equipment, internally-powered equipment. 21.5°C (70.7°F) ± 1.5°C to 38.0°C (100.4°F) in 0.1°C increments 30 min. (nominal) 1.0°C (1.8°F) 2.0°C (3.6°F) 1.0°C (1.8°F)

Regulations, Standards, and Codes The Transport Incubator, Model TI500 complies with the following safety and performance standards: • EN 60601-1-1990, Medical Electrical Equipment, Part 1: General Requirements for Safety, including Amendments 1 and 2 • EN 60601-1-2-2002, Collateral Standard: Electromagnetic Compatibility-Requirements and Tests

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INTRODUCTION FEATURES SPECIFICATIONS

Operating range (normal)

Dimension

• EN 60601-2-20-1996, Particular Requirements for the Safety of Transport Incubators, including Amendment 1

Guidance and Manufacturer’s Declaration- Emissions The TI500 Transport Incubator is intended for use in the electromagnetic environment specified below. The customer or user of the unit should ensure that the unit is used in such an environment. Emissions Test

Compliance

Radio frequency (RF) emissions- CISPR 11

Group 1

RF emissions CISPR 11

Class B

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Electromagnetic Environment- Guidance The TI500 Transport Incubator uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause interference with nearby electronic equipment. Although the TI500 Transport Incubator is not intended for operation from the public low-voltage power supply network, the product does comply with the more restrictive RF Emission levels of Class B.

Transport Incubator (Model TI500) User Manual (67 990 70)

Guidance and Manufacturer’s Declaration- Emissions The TI500 Transport Incubator is intended for use in the electromagnetic environment specified below. The customer or user of the unit should ensure that the unit is used in such an environment. Compliance

Harmonics IEC 61000-3-2 Voltage fluctuations/flicker emissions IEC 61000-3-3

Not Applicable Not Applicable

Electromagnetic Environment- Guidance The TI500 Transport Incubator 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.

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INTRODUCTION FEATURES SPECIFICATIONS

Emissions Test