Air Shields Isolette Models C400 QT and C450 QT Instructions for Use Edition 11 Jan 2011

Trademarks Care-For-Me™ is a trademark of Draeger Medical Systems, Inc. Critter Covers® is a registered trademark of Draeger Medical Systems, Inc. Dew-ette® 2 is a registered trademark of Draeger Medical Systems, Inc. Isolette® is a registered trademark of Draeger Medical Systems, Inc. Kleenaseptic® is a registered trademark of Metrex Research Corporation. Kleenaseptic®-B™ is a trademark of Metrex Research Corporation. QT® is a registered trademark of Draeger Medical Systems, Inc.

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PROPRIETARY AND CONFIDENTIAL DRAFT 19 Nov 04 Table of Contents Section 1: Symbol Definition and Intended Use Symbol Definition... 1 - 1 Technical Definitions... 1 - 4 Intended Use... 1 - 4 Section 2: Introduction, Features, and Specifications Introduction... 2 - 1 Functional Description... 2 - 2 Features... 2 - 3 Standard Features... 2 - 3 Temperature Control... 2 - 3 Alarms... 2 - 4 Continuously Variable Mattress Tilt Mechanism... 2 - 6 Quiet Latch Access Doors... 2 - 6 Optional Features... 2 - 6 Accessories... 2 - 7 Specifications... 2 - 7 Standard Features... 2 - 8 Optional Features... 2 - 10 Alarms... 2 - 10 Regulation, Standards, and Codes... 2 - 11 Device Classification... 2 - 11 Electromagnetic Compatibility (EMC) Guidance and Manufacturer’s Declaration... 2 - 11 Section 3: Precautions and Safety Tips Precautions... 3 - 1 Electrical Precautions... 3 - 1 Explosion Precautions... 3 - 1 Oxygen Precautions... 3 - 2 Electromagnetic Compatibility Precautions... 3 - 3 Safety Tips... 3 - 4 Swivel Monitor Shelves... 3 - 7 Warning Labels... 3 - 8 Section 4: Installation and Assembly Installation... 4 - 1 Unpacking... 4 - 1 Assembly... 4 - 2 Incubators Equipped with the Standard Cabinet Stand... 4 - 2 5

PROPRIETARY AND CONFIDENTIAL DRAFT 19 Nov 04 Incubators Equipped with a Variable Height Adjustable (VHA) Stand... 4 - 3 Warm Weigh® Infant Scale, Model I20 (Accessory)... 4 - 4 General Operation and Functional Checkout Procedure... 4 - 5 Section 5: Instructions for Use Instructions for Use... 5 - 1 Air Mode... 5 - 3 To Select:... 5 - 3 Auxiliary Air Probe... 5 - 3 Baby Mode... 5 - 4 Oxygen Therapy... 5 - 5 Humidity Reservoir... 5 - 7 Controls, Indicators, and Connectors... 5 - 8 Optional Features... 5 - 14 Accessories... 5 - 16 Cabinets and Drawers... 5 - 17 Swivel Shelves... 5 - 17 Section 6: Cleaning, Maintenance, Replacement Parts, and Storage and Handling Cleaning... 6 - 1 General Cleaning... 6 - 1 Cleaning Agents... 6 - 1 Steam Cleaning... 6 - 2 Cleaning Difficult to Access Areas... 6 - 2 Cleaning Painted Surfaces... 6 - 2 Cleaning Clear Plastic and Acrylic Surfaces... 6 - 2 Disinfecting... 6 - 2 Disassembly for Cleaning... 6 - 2 Cleaning... 6 - 5 Cleaning the Skin Probe (Model C450 QT® Isolette® Infant Incubator Only)... 6 - 5 Cleaning the Humidity Chamber and Fill Pipe, Air Intake Tube, Access Door Gaskets, and Tubing Access Gaskets... 6 - 6 Cleaning the Controller... 6 - 6 Cleaning the Mattress Tray and Deck Plate... 6 - 7 Cleaning the Mattress Tilt Control... 6 - 7 Cleaning the Hood and Cabinet Stand... 6 - 7 Cleaning the Air Intake Microfilter Chamber... 6 - 7 Assembly After Cleaning... 6 - 8 Maintenance... 6 - 11 Power Failure Alarm Battery Maintenance... 6 - 11 6

PROPRIETARY AND CONFIDENTIAL DRAFT 19 Nov 04 Replacement Parts... 6 - 12 Storage and Handling... 6 - 13 Storage... 6 - 13 Operation... 6 - 13 Disposal... 6 - 13 Section 7: Troubleshooting Troubleshooting... 7 - 1

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PROPRIETARY AND CONFIDENTIAL DRAFT 19 Nov 04 NOTES:

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PROPRIETARY AND CONFIDENTIAL DRAFT 19 Nov 04

Section 1 Symbol Definition and Intended Use

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

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PROPRIETARY AND CONFIDENTIAL DRAFT 19 Nov 04 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 B equipment with an F-type floating applied part:” Type B Equipment with an F-Type Floating Applied Part

• The symbol below indicates “AC power:” AC Power

• The symbol below indicates “Protective earth (ground):” Protective Earth (Ground)

• The symbol below indicates “Air Mode Control indicator:” Air Mode Control Indicator

• The symbol below indicates “Air Mode Control selection key:” Air Mode Control Selection Key

• The symbol below indicates “Baby Mode Control indicator:” Baby Mode Control Indicator

• The symbol below indicates “Baby Mode Control selection key:” Baby Mode Control Selection Key

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PROPRIETARY AND CONFIDENTIAL DRAFT 19 Nov 04 • The symbol below indicates the Keypad Lock key: Keypad Lock Key

• The symbol below indicates the Keypad Lock indicator: Keypad Lock Indicator

• The symbol below indicates the Set Temperature keys: Set Temperature Keys

• The symbol below indicates the Temperature Override Mode (>37°C) selection key: Temperature Override Mode (>37°C) Selection Key

• The symbol below indicates the Temperature Override Mode (>37°C) indicator: Temperature Override Mode (>37°C) Indicator

• The symbol below indicates the Silence/Reset switch: Silence/Reset

• The symbol below indicates the Power Off/On switch: Power Off/On

• The symbol below indicates that the cabinet stand doors must remain closed to minimize the risk of tipping during transport: Cabinet Stand Doors Must Remain Closed

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PROPRIETARY AND CONFIDENTIAL DRAFT 19 Nov 04 • The symbol below indicates a sensitivity to ELECTROSTATIC DISCHARGE (ESD): Electrostatic Discharge (ESD)

• The symbol below indicates the surface could be hot. Caution, Hot Surface

Technical Definitions • Control zone-A plane 10 cm (4") above the mattress with an area defined by the center of four quadrants formed by lines that divide the width and length of the mattress surface. • Incubator temperature-The air temperature at a point 10 cm (4") above and centered over the mattress surface. • Average incubator temperature-The average of the maximum and minimum incubator temperature achieved during steady temperature condition. • Steady temperature condition-The condition reached when the average incubator temperature does not vary more than 0.5°C over a period of 1 hour. • Temperature overshoot-The amount by which the incubator temperature exceeds the average incubator temperature during steady temperature condition, resulting from a change in temperature. • Temperature rise time-The time required for the incubator temperature to rise 11°C (20°F). • Temperature uniformity-The amount by which the average temperature at each of four points 10 cm (4") above the mattress surface differs from the average incubator temperature at steady temperature condition. The four points are the centers of four quadrants formed by lines that divide the width and length of the mattress surface. • Temperature variation-The difference between the incubator temperature and the average incubator temperature during steady temperature condition.

Intended Use This manual provides instructions for installation, use, operator maintenance, and troubleshooting of the Model C400 (discontinued January 2005) and C450 Isolette® Infant Incubator having QT® features, CE Mark version. Dräger Medical cannot be responsible for the performance of the incubator if the user does not operate the unit in accordance with the instructions, fails to follow the maintenance recommendations of the manual, or makes any repairs with unauthorized components. Only qualified service personnel should perform calibration and repair. Technical information is available 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 on the shelf in the cabinet stand when not in use. If there is anything you do not understand, please contact your technical support representative for further information. 1-4

DRAFT 19 May 2005

Section 2 Introduction, Features, and Specifications

Introduction The forced air circulation system of the incubator permits stable temperature control, uniform heat distribution, humidification, effective isolation of the infant from airborne contaminants, and control of oxygen concentrations. An access panel, access doors, and iris entry ports provide accessibility to the infant. When the access panel is open, a curtain of warm air flows from beneath the front edge of the mattress toward the top of the access panel opening; this air curtain minimizes the temperature drop within the hood environment. The incubator is designed for use in a nursery environment having a typical ambient operating temperature range of 20°C (68°F) to 30°C (86°F). A guard rail is standard. On Model C450 QT® Isolette® Infant Incubator, baby or air temperature control is selected by a front panel control. The Model C400 QT® Isolette® Infant Incubator (discontinued January 2005) is equipped only for air temperature control. Instrumentation includes a digital display for temperature, relative indication of heater output, and a comprehensive visual and audible alarm system, which includes an alarm test feature.

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DRAFT 19 May 2005 Functional Description The forced air circulation system controls temperature, humidity, and oxygen concentration. The motor-driven impeller on the controller draws a controlled amount of room air (approximately 35 litres per minute (lpm)) through the air intake filter. Supplemental oxygen, introduced through the oxygen input valve on the air intake filter cover, displaces a portion of room air to maintain the total gas intake (including oxygen) at 35 lpm. Since the impeller/filter characteristics control the amount of room air, and the flowmeter setting controls the amount of oxygen, predictable oxygen concentrations within the incubator can be attained. When oxygen flow exceeds 8 lpm, a valve within the oxygen inlet housing restricts air intake so that a higher oxygen concentration can be achieved without excessive oxygen flow. At 12 lpm, maximum air intake restriction is achieved. In addition to drawing fresh, filtered air into the incubator, the impeller internally recirculates at a much greater flow than that of the fresh gas inflow. The total flow of fresh plus recirculated air is directed past the air flow sensor and around the heater with a predetermined portion being directed over the humidity reservoir for humidification. When the access panel of the hood is closed, the air curtain cover is closed, and all the air enters the infant compartment up through the slot at the right end of the main deck. After circulating within the infant compartment, the air is then recirculated down through the slot in the left end of the main deck. There it goes past the temperature sensing probe, which encapsulates the air temperature control thermistor and a high air temperature alarm thermistor, and back to the impeller. When the access panel of the hood is open, the air curtain cover is raised, permitting a portion of the air to flow upward past the opening creating a warm air curtain, which minimizes the drop in air temperature in the incubator.

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DRAFT 19 May 2005 Features Isolette® Infant Incubator with Standard Cabinet Stand

Standard Features Temperature Control On the Model C450 QT® Isolette® Infant Incubator, temperature is regulated by using either incubator air or the infant's skin temperature as the controlling parameter. A front panel key enables selection of the desired mode. The Model C400 QT® Isolette® Infant Incubator (discontinued January 2005) provides only Air Mode. In either mode of operation, the heater output is proportional to the amount of heat required to maintain the desired temperature, and the relative amount of heat being provided is indicated by the number of lit Heater Power % indicators on the front panel. Changes in the number of lamps illuminated indicate the amount of power required to maintain a given temperature. During Baby Mode, the Model C450 QT® Isolette® Infant Incubator provides an indication of the degree of the infant's dependency upon the temperature of its environment to maintain body temperature.

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DRAFT 19 May 2005 Air Mode

In Air Mode, the air temperature can be maintained from 20°C (68°F) to 37°C (99°F) as indicated by the Set Temp °C display setting. In Temperature Override Mode, the temperature can be maintained from 37°C (99°F) to 38.5°C (101.3°F). A probe located below deck monitors the air temperature, and compares it with the Set Temp °C display setting. The information from this probe is supplied to the heater control circuitry, which proportions the heater output to maintain the air temperature at the Set Temp °C display setting. Actual air temperature is displayed by the Air Temperature °C display. A second sensor within the air temperature probe serves as a backup to limit the incubator temperature to between 39°C (102°F) and 40°C (104°F). At this temperature, an alarm activates, and the heater shuts off. If desired, an auxiliary air temperature probe can control the air temperature. This probe is suspended above the mattress through the weighing scale hole, and plugged into a special receptacle on the side of the incubator. When plugged in, the primary air temperature control probe is disconnected, but the backup sensor within the primary temperature probe remains connected. Thus, the auxiliary probe controls the air temperature. In Air Mode, the infant's temperature is a function of the air temperature and the infant's ability to establish and maintain its own temperature. A small infant, or one with underdeveloped homeostatic control, may not be able to maintain a stable temperature at the desired level. Baby Mode (Model C450 QT® Isolette® Infant Incubator Only) In Baby Mode, the infant’s skin temperature can be maintained from 34°C (93°F) to 37°C (99°F) as indicated by the Skin Temp °C display. In Temperature Override Mode, the temperature can be maintained from 37°C (99°F) to 37.9°C (101.3°F). A temperature sensing probe is attached directly to the infant's skin. The information from the probe is supplied to the heater control circuitry, which proportions the heater output to maintain the baby's temperature at the Set Temp °C setting. The actual baby temperature appears on the Baby Temperature °C display. The Set Temp °C setting does not control air temperature while in Baby Mode, but air temperature is still displayed. The air temperature is still limited to 38.5°C (101.3°F). If Air Mode is selected while the skin probe remains connected, the Baby Temperature °C display continues to display actual skin temperature, but it does not control. If the probe is disconnected from its receptacle during Baby Mode, the Baby Temperature °C display goes blank, and a Probe alarm activates. The high temperature alarm sensor within the air temperature probe remains in the circuit to limit the air temperature to less than 40°C (104°F). Alarms Alarms are provided for power failure, system failure, inadequate air flow, probe failure, high temperature, and variation from the set temperature. Each time the unit is turned on, the unit automatically goes through an alarm check sequence to verify proper alarm function. After the automatic alarm check, the low Set Temp alarm is disabled for 60 min or until the temperature reaches the Set Temp °C setting, whichever occurs first. Each of these alarms is described below. Air Flow

A sensor located below deck in the normal air path of the fan controls this alarm. If air flow stops due to a fan failure, the temperature of the self-heated sensor rises, causing the Air Flow alarm indicator on the front panel to light and produce a pulsating tone. A short-circuited, air flow sensor failure also actuates the alarm within 10 s of the failure. This alarm is not self-resetting and cannot be silenced or canceled by the Silence/Reset key until the alarm condition is corrected.

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DRAFT 19 May 2005 High Temperature

A second sensor within the air temperature probe sounds this alarm if the incubator temperature reaches 39.5°C ± 0.5°C (103.1°F ± 0.9°F). A solid light and a pulsing tone indicate a High Temperature alarm. This alarm is not self-resetting and cannot be canceled by the Silence/Reset key until the alarm condition is corrected. Power Failure

If primary power to the incubator is interrupted for any reason, including a disconnected power cord, an audible alarm is activated, and the Power Fail indicator lights. To silence this alarm for two min, press the Silence/Reset key. To deactivate this alarm, restore the primary power or set the incubator Power switch to off. System Fail

If an internal malfunction is detected, the System Fail indicator flashes and the alarm sounds. This alarm is not resettable. Refer the unit to qualified service personnel. Probe

Circuitry is provided to monitor the air, skin, and high temperature sensors for short circuits, open circuits, or disconnected conditions and the air flow sensor for an open condition. The Probe alarm actuates within 10 s if the air flow sensor has an open circuit and the temperature sensed below the mattress deck is greater than approximately 30°C (86°F). However, if the temperature sensed below the mattress deck is less than that, the alarm does not activate. During warm-up, it can take anywhere from 15 to 30 min before the alarm actuates, depending on the temperature setpoint and the ambient room temperature. If the high set temperature is below 29°C (84°F), the Probe alarm indicating an open-circuited air flow sensor is not activated. If a probe shorts (except for the air flow probe or High Temperature alarm probe), it also appears as a set temperature violation, and the Set Temp alarm indicator lights. This alarm is not self-resetting and cannot be canceled by the Silence/Reset key until the alarm condition is corrected. If a Probe alarm occurs simultaneously with a Set Temp alarm, a shorted probe is probably the true cause of the alarm since a shorted probe appears as a high temperature condition. On the Model C450 QT® Isolette® Infant Incubator, a Probe indicator light flashes and an alarm sounds within 10 s to indicate a damaged air temperature, baby temperature, auxiliary air sensor, or an opencircuited air flow sensor. The Probe alarm also activates if the skin temperature probe is disconnected while in Baby Mode. The Model C400 QT® Isolette® Infant Incubator (discontinued January 2005) is equipped only for air control. Therefore, no Baby Mode Probe alarm is provided. The Probe alarm activates to indicate a damaged air temperature, or auxiliary sensor, or an open-circuited air flow sensor. Set Temperature

The Set Temperature alarm actuates if the baby or air temperature fluctuates from the set temperature as follows: • Baby temperature-+1.0°C ± 0.3°C, -1.0°C ± 0.3°C • Air temperature-+1.5°C ± 0.5°C, -3.0°C ± 0.5°C (-2.5°C ± 0.5°C for IEC units)

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DRAFT 19 May 2005 A temperature below the set temperature is indicated by a flashing light, a tone, and the set temperature setting alternating with LO in the Set Temp °C display. A temperature above the set temperature is indicated by a flashing light, a tone, and the set temperature setting alternating with HI in the Set Temp °C display. If a Set Temp alarm occurs simultaneously with a Probe alarm, a shorted probe is probably the true cause of the alarm, since a shorted probe appears as a high temperature condition. The Set Temperature alarm is self-resetting (that is, if the alarm condition is corrected, the alarm automatically silences, and the light turns off). To silence the Set Temperature alarm, press the Silence/Reset key. The other audible and visual alarms are not affected by the use of the 15-min alarm silence. When silenced, the alarm indicator remains on until the alarm condition is corrected. If the alarm condition is not corrected within 15 min, the audible alarm reactivates. If you change the air or baby set temperature (either high or low) after the incubator is in operation, the Set Temperature HI and LO alarms automatically silence for a specific amount of time after the change. The time the alarm remains silent is 5 min per degree (plus or minus) change from the current set temperature. If the incubator fails to reach the new set temperature after the specified time, the alarm sounds. For example, if you change the set temperature ±1.5°, the alarm silence period is 7.5 min. Continuously Variable Mattress Tilt Mechanism The Isolette® Infant Incubator is equipped with a 0° to ± 9° continuously variable mattress tilt mechanism, which permits placing the infant in the Trendelenburg or Reverse Trendelenburg position. Quiet Latch Access Doors The Isolette® Infant Incubator is equipped with quiet-latching access doors. The latch mechanism of these doors is designed so that the doors may be opened with an elbow one at a time or simultaneously.

Optional Features Optional features available for use with the Isolette® Infant Incubator include: • Filter Cover with O2 Limiter • Filter Cover with Dew-ette® 2 Incubator Humidifier

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DRAFT 19 May 2005 Accessories Accessories available for use with the Isolette® Infant Incubator include: • Cabinet Stand (standard) • Guard Rail • Micro-Lite® Phototherapy System • Dew-ette® 2 Incubator Humidifier • Remote Alarm Module • Warm Weigh® Infant Scale, Model I20 • Monitor Shelf Package • Utility Pole Assembly • I.V. Tree Assembly • Oxygen Flowmeter Kit • Rail System

Specifications Specifications for the Isolette® Infant Incubator are provided. All specifications are subject to change without notice. Opening access doors or panels, or using infant seats, head hoods, or other equipment or supplies within the incubator, which can alter the air flow pattern, may affect temperature uniformity, temperature variability, the correlation of the incubator temperature reading to center mattress temperature, and infant skin temperature.

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DRAFT 19 May 2005 Standard Features Feature Power requirements

Chassis leakage current Air Mode temperature control range Baby Mode temperature control range (Model C450 QT® Isolette® Infant Incubator only) Temperature rise time Temperature variation Temperature overshoot Temperature uniformity Correlation of indicated air temperature to actual incubator temperature (after steady temperature condition is reached) Correlation of indicated air temperature to set temperature (Air Mode) Correlation of indicated air temperature to set temperature (Baby Mode) (Model C450 QT® Isolette® Infant Incubator only) Oxygen concentration range Humidity (with no supplemental oxygen, set temperature > 32°C, and ambient temperature at 20°C to 30°C) Height from floor (mounted on cabinet stand) Depth (mounted on cabinet stand) Width (mounted on cabinet stand) Weight with guard rail and no accessories (mounted on cabinet stand) Mattress dimensions Mattress tilt Trendelenburg/Reverse Trendelenburg

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Dimension 120V ± 10%, 50/60 Hz, 500 W maximum 230V ± 10%, 50/60 Hz, 500 W maximum 100V ± 10%, 50/60 Hz, 500 W maximum less than 500 uA (220V to 240V units) less than 100 uA (120V units) 20°C (68°F) to 37°C (99°F) (37°C (99°F) to 38.5°C (101.3°F) in Temperature Override Mode) 34°C (93°F) to 37°C (99°F) (37°C (99°F) to 37.9°C (100.2°F) in Temperature Override Mode) < 50 min 1.5°C 0.5°C maximum 1.0°C 0.8°C (IEC/CE units) ± 1.0°C

± 0.8°C (IEC/CE units) ± 0.5°C ± 0.3°C

21% to 65% or greater Typically between 50% and 60% with water in the humidity reservoir 137 cm (53.75") 140 cm (55") (IEC/CE units) 53 cm (21") without guard rail, 56 cm (22") with guard rail 94 cm (37") without guard rail, 115 cm (45") with guard rail 76 kg (168 lb) 63 cm (24.8") x 34.8 cm (13.7") 0° to 9° ± 1°, continuously variable

DRAFT 19 May 2005 Feature Ambient operating temperature range Non-condensing operating humidity range Ambient storage temperature range Non-condensing storage humidity range Noise level within the hood environment

Air velocity over mattress Carbon dioxide (CO2) within the hood

Warm-up time, as specified by sub-clause 50.108 of EN 60601-2-19

Dimension 20°C (68°F) to 30°C (86°F) 5% to 95% relative humidity -30°C (-22°F) to 70°C (158°F) 0% to 99% relative humidity 60 dBA or less, 10 cm (4") above center mattress in surroundings of 39 dBA or less 80 dBA or less with an alarm sounding Does not exceed 25 cm/s (11"/s) within the Control Zone < 0.5% when a 4% mixture of CO2 in the air is delivered at 740 ml/min at a point 10 cm (4") above the center of the mattress 35 minutes

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