Resuscitaire Models WBR82, RW82 and WMRW82 Instructions for Use Edition 9 Nov 2010

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Trademarks AutoBreath™ is a trademark of Draeger Medical Systems, Inc. Care-For-Me™ is a trademark of Draeger Medical Systems, Inc. Critter Covers® is a registered trademark of Draeger Medical Systems, Inc. Nylok® is a registered trademark of Nylok Fastener Corporation. Resuscitaire® is a registered trademark of Draeger Medical Systems, Inc. VentStar™ is a trademark of Draeger Medical Systems, Inc.

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PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Table of Contents Section 1: Symbol Definition and Intended Use Symbol Definition... 1-1 Dictionary of Common Terms... 1-4 Intended Use... 1-6 Section 2: Introduction, Features, and Specifications Introduction... 2-1 Warmer Module... 2-1 Cart/Bassinet (Resuscitaire Birthing Room Warmer (WBR82) and Cart only)... 2-1 Bassinet (Resuscitaire Radiant Warmer (RW82) only)... 2-1 Controller... 2-1 Blender Module (Optional)... 2-2 Resuscitation Module (Optional)... 2-2 Resuscitation Module without Autobreath™ Infant Resuscitator... 2-3 Resuscitation Module with AutoBreath™ Infant Resuscitator... 2-5 Suction... 2-7 Suction Line Filter... 2-8 Gas Supply Module (Optional)... 2-8 Apgar Timer... 2-8 Weigh Scale... 2-8 Alarms... 2-9 High Temperature... 2-9 Check Patient... 2-9 Probe... 2-9 Baby Temperature... 2-9 Power Failure... 2-9 System Failure... 2-9 Blender Differential Bypass (Optional)... 2-10 Features of the Resuscitaire Birthing Room Warmer (WBR82)... 2-11 Features of the Resuscitaire Radiant Warmer (RW82)... 2-12 Features of the Resuscitaire Wall Mounted Radiant Warmer (WMRW82)... 2-13 Standard Features... 2-13 Bassinet (Resuscitaire Birthing Room Warmer (WBR82) and Resuscitaire Radiant Warmer (RW82) only)... 2-13 Warmer Module... 2-13 Controller... 2-13 Optional Features (Resuscitaire Birthing Room Warmer (WBR82) and Resuscitaire Radiant Warmer (RW82) only)... 2-14 i

PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Accessories... 2-14 Specifications... 2-16 Standard Features... 2-16 Optional Features (Resuscitaire Birthing Room Warmer (WBR82) and Resuscitaire Radiant Warmer (RW82) only)... 2-18 Accessories (WBR82 and RW82 only)... 2-20 Alarms... 2-20 Regulations, Standards, and Codes... 2-21 Device Classification (EN60601 Medical Electrical Equipment Part I: General Requirements for Safety)... 2-21 Electromagnetic Compatibility (EMC) Guidance and Manufacturer’s Declarations... 2-22 Section 3: Precautions and Safety Tips Precautions... 3-1 Electrical Precautions... 3-4 Explosion Precautions... 3-4 Oxygen Precautions... 3-4 Low-Flow Microblender Precautions... 3-6 Resuscitation Precautions... 3-7 AutoBreath™ Infant Resuscitator Precautions... 3-9 Suction Precautions... 3-11 System Precautions... 3-11 Electromagnetic Compatibility Precautions... 3-12 Safety Tips... 3-13 Warning Labels... 3-16 Section 4: Installation and Assembly Installation... 4-1 Assembly of the Resuscitaire Birthing Room Warmer (WBR82)... 4-2 Warmer... 4-2 Cart and Bassinet... 4-5 Assembly of the Resuscitaire Radiant Warmer (RW82)... 4-6 Warmer... 4-6 Assembly of the Resuscitaire Wall Mounted Radiant Warmer (WMRW82)... 4-10 Mounting of the Resuscitaire Wall Mounted Radiant Warmer (WMRW82)... 4-12 Operational Checkout Procedure... 4-14 Controller... 4-14 Mechanical Operation... 4-16 Resuscitation Equipment (Optional)... 4-19 Resuscitation Module (Optional)... 4-22 ii

PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Resuscitation Module with AutoBreath™ Infant Resuscitator (Optional)... 4-24 Blended Gas Supply (Optional)... 4-25 Section 5: Instructions for Use Instructions for Use... 5-1 Controls, Indicators, and Connectors (Resuscitaire Birthing Room Warmer (WBR82) shown)... 5-1 Resuscitation Module... 5-12 Controller... 5-13 Pre-Warm Mode... 5-13 Manual Mode... 5-13 Baby Mode... 5-15 Examination Light... 5-17 Cart and Bassinet... 5-18 End and Side Panels... 5-18 Bassinet Tilt Control... 5-18 Vari-tilt Control... 5-19 Docking and Undocking (Resuscitaire Birthing Room Warmer (WBR82) only)... 5-19 X-Ray Cassette Tray Accessory (optional)... 5-20 Universal Cylinder Bracket (Optional)... 5-20 Section 6: Cleaning, Maintenance, Replacement Parts, and Storage and Handling Cleaning... 6-1 General Cleaning... 6-2 Cleaning Agents... 6-2 Steam Cleaning... 6-2 Cleaning Difficult to Access Areas... 6-2 Cleaning Painted Surfaces... 6-2 Cleaning Clear Plastic and Acrylic Surfaces... 6-2 Cleaning Metal Surfaces... 6-3 Cleaning Wood Surfaces... 6-3 Cleaning the Reusable Skin Temperature Probe... 6-3 Cleaning the Reusable Suction Bottle... 6-3 Cold or Gas (Ethylene Oxide) Sterilization... 6-4 Disassembly for Cleaning... 6-4 Assembly After Cleaning... 6-6 Maintenance... 6-7 Calibration... 6-7 Pneumatic System... 6-7 Replacement Parts... 6-8 iii

PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Storage and Handling... 6-10 Storage... 6-10 Transport... 6-10 Operation... 6-10 Disposal... 6-10 Section 7: Troubleshooting Troubleshooting... 7-1 System Fail Error Codes... 7-3

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PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 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 an ELECTRICAL SHOCK HAZARD WARNING: Electrical Shock Hazard Warning

• The symbol below indicates Attention: Consult accompanying documents: Attention: Consult Accompanying Documents

This product contains different icons designed to increase understanding. Note the following examples: • The symbol below indicates Type B equipment with an F-type isolated (floating) applied part: Type B Equipment with an F-Type Isolated (Floating) Applied Part

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PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 • The symbol below indicates a disposable suction bottle: Disposable Suction Bottle

• The symbol below indicates a reusable suction bottle with suction line filter: Reusable Suction Bottle

• The symbol below indicates a patient: Patient

• The symbol below indicates the Suction Line Filter: Suction Line Filter

• The symbol below indicates the Power On/Off key: Power On/Off Key

• The symbol below indicates the Celsius/Fahrenheit Selection key: Celsius/Fahrenheit Selection Key

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

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

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PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 • The symbol below indicates the Apgar Timer keys: Apgar Timer Keys

• The symbol below indicates the Procedural Silence indicator: Procedural Silence Indicator

• The symbol below indicates the Silence/Reset key: Silence/Reset Key

• The symbol below indicates the Mode Select key: Mode Select Key

• The symbol below indicates the Keypad Lock key: Keypad Lock Key

• The symbol below indicates the Examination Light key: Examination Light Key

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PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Dictionary of Common Terms This manual contains some terms that could be confused or can be used interchangeably. This section is designed to increase understanding of its content. Note the following examples: Alarm: may require user intervention, usually includes an audible beep or series of beeps Alert: system information update, may consist of a text message on the display or an audible beep AAP: American Academy of Pediatrics Absolute humidity: pressure exerted by water pressure in the air, measured in mmHG (millimeters of mercury) like blood pressure, independent of air temperature ACOG: American College of Obstetrics and Gynecology Apgar: named for Dr. Virginia Apgar. After birth, the infant is rated and assessed according to Appearance, Pulse, Grimace, Airway, and Respiration Apnea: cessation of breathing. Central apnea means the infant stops breathing. Obstructive apnea means that something is preventing the infant from breathing Average Db: decibel measurements smoothed to represent consistent sound measurement in the acoustic environment (averaged over 1 minute) Baby Mode: warmer temperature control mode whereby heater output is determined by baby temperature via a skin temperature sensor attached to the baby's skin NOTE: Baby Mode, Skin Mode, and Servo Mode can be used interchangeably Conduction: heat transfer between a surface colder or hotter than itself by direct contact Convection: heat transfer due to warm or cold air currents Core temperature: infant’s internal temperature Decibel (Db): numerical expression of the relative loudness of a sound ELBW: Extremely Low Birth Weight, micro-preemie Evaporation: conversion of a liquid to a vapor which causes thermal dissipation when body heat is consumed by the process Flow Rate and Flow Rate (LPM): flow meter, LPM = liters per minute as measured by a flow meter Foot Candle: measurement of light and the relative illumination of a surface Hyperthermia: patient is too hot (hyper = too much; thermia = heat) Hypothermia: patient is too cold (hypo = not enough; thermia = heat) Hypoxia: lack of oxygen IR: infrared, primary method of heat gain from warmer heating elements Keratin: component of epidermal skin layer in mature skin. Premature skin has lower levels of keratin in the epidermal (outer) skin layer, which is why premature babies have higher evaporative heat losses. This layer normally develops about 2 weeks after birth. LBW: Low Birth Weight (term for premature babies) Lux: measurement of light and illumination of a surface 1-4

PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Manual Mode: warmer temperature control mode where users determine the heater output to the infant manually Non-shivering Thermogenesis: Premature infants do not shiver. Term infants do, however, have rich mitochondrial areas in brown adipose tissue called "brown fat" which creates heat for the infant metabolically when required. The "brown fat" is used up in the process. Peak Decibel: decibel measurements showing continual, meaning maximum, sound level measurement, more reflective of subtle changes to acoustic environment Preemie: premature infant, born <37 weeks gestation Pre-Warm mode: Pre-Warm mode is typically associated with radiant warmers. The system will enable the overhead heaters at 100% for 3 min, then reduces to 60% for 12 min, and then reduces again to 30%. Thus, when the patient is admitted to the bed, it is already warm and the heating elements can respond quickly to user or patient requirements. Relative Humidity: amount of water vapor present in the air, expressed as a percentage and temperature dependent RT: Respiratory Therapist, someone who provides ventilator, resuscitation, and other pulmonary support for patients Radiation: heat transfer to a warm or cold surface NOT in contact Servo Mode: closed loop systems that automatically maintain set levels based on feedback to a source. For example, Baby mode temperature control is a servo system that controls heat processes to the patient based on that infant's temperature. NOTE: Baby Mode, Skin Mode, and Servo Mode can be used interchangeably Skin temperature: evaluation of patient temperature as measured on the skin. All of our probes are skin measurement probes, and are attached to the skin via probe covers. Typically, there is a difference of approximately 0.5 C between skin temperature and core temperature. 0

Thermoneutral Zone: temperature at which an infant's temperature is regulated such that metabolic processes are minimized, oxygen consumption is optimized, and temperature losses are minimized Thermoregulation: ability to control and balance heat processes (convection, conduction, radiation, and evaporation) to minimize infants’ heat losses and encourage growth Trendelenburg: elevating one end of the mattress UV: ultraviolet light, a component of the normal spectrum of white light VLBW: Very Low Birth Weight baby

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PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Intended Use This manual provides instructions for installation, use, operator maintenance, and troubleshooting of the Resuscitaire® Birthing Room Warmer (WBR82), the Resuscitaire Radiant Warmer (RW82), and the Resuscitaire Wall Mounted Radiant Warmer (WMRW82). Dräger Medical cannot be responsible for the performance of the equipment if the user does not operate the equipment in accordance with the instructions, fails to follow the maintenance recommendations, or makes repairs with unauthorized components. Only qualified service personnel should calibrate or repair the unit as indicated in the service manual. Service manuals are available from technical support. The Resuscitaire Birthing Room Warmer (WBR82) is designed especially for labor and delivery use. It consists of a detachable cart and bassinet and a freestanding warmer that provides heat control and monitors skin temperature and includes an Apgar timer. The Resuscitaire Birthing Room Warmer also includes an optional resuscitation package with suction and oxygen delivery. Other options include a reserve gas supply and blender. The Resuscitaire Radiant Warmer (RW82) is designed for use during labor and delivery. The Resuscitaire Radiant Warmer consists of a bassinet, warmer, and a controller module that provides heat control, monitoring of the skin temperature, and Apgar timing. The Variable Height (VHA) Resuscitaire Radiant Warmer provides an adjustable mattress height. The Resuscitaire Radiant Warmer also includes the same optional resuscitation package with suction and oxygen delivery that is available with the Resuscitaire Birthing Room Warmer. The Resuscitaire Wall Mounted Radiant Warmer (WMRW82) is designed specifically for labor, delivery, and birthing room use. The Resuscitaire Wall Mounted Radiant Warmer consists of a warmer and a controller module that provide heat control, monitoring of the skin temperature, and an Apgar timer. The Resuscitaire Wall Mounted Radiant Warmer is installed permanently and, therefore, is not portable. There are no resuscitation options available with this product. All personnel who work with the equipment should read, thoroughly understand, and have ready access to this user manual. When not in use, store the manual with the equipment. If there is anything you do not understand, please contact your technical support representative for further information.

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Section 2 Introduction, Features, and Specifications

Introduction There are three versions of the Resuscitaire Radiant Warmer product: the Resuscitaire Birthing Room Warmer (WBR82), the Resuscitaire Radiant Warmer (RW82), and the Resuscitaire Wall Mounted Radiant Warmer (WMRW82).

Warmer Module A controller provides Pre-Warm Mode, Manual Mode, or Baby Mode (servo skin temperature control) to control the warmer. An examination light provides additional illumination of the mattress area. A warmer head pivot allows the warmer to be pivoted to either side for x-ray procedures. Additionally, when the warmer is pivoted, it continues to provide heat.

Cart/Bassinet (Resuscitaire Birthing Room Warmer (WBR82) and Cart only) The bassinet is designed to provide maximum function and utility to aid in the care of the newborn. It is detachable so you can transport the infant to the NICU, the general nursery, or another area of the hospital. The side and front panels fold down to permit access to the infant. The mattress tilts at a 0°, 5°, or 10° angle. Openings are provided on each side of the bassinet for the insertion of the accessory x-ray cassette tray. A writing surface is available; when the writing surface is closed, it is not visible. Each cart has a pass-through drawer and a locking front access drawer. The cart locks in place when used with a warmer.

Bassinet (Resuscitaire Radiant Warmer (RW82) only) The bassinet is designed to provide maximum function and utility to aid in the care of the newborn. You may fold the side and front panels down to gain access to the infant. The mattress tilts at a 0°, 5°, or 10° angle. Openings are provided on each side of the bassinet for the insertion of the accessory x-ray cassette tray. A push-through drawer is supplied standard on every unit.

Controller At power-up, the microprocessor within the controller performs a series of diagnostic tests to confirm the proper operation of the system. During this time, all display and indicators light, except for Power Fail, and a tone sounds. When powered-up, the system initializes in Pre-Warm Mode, the controller starts the heater at 100% power and maintains that setting for 3 min, reduces to 60% for 12 min, and then reduces the heater power to 30%. During the low heat setting, the unit continues to provide heat with no low limit alarms enabled. When operating the controller in Manual Mode, you can adjust the heater power from 0% to full power in 10% increments. After 10 min of operation in Manual Mode, the Check Patient alarm occurs. To silence 2-1

PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 the alarm for 10 minutes, verify the infant’s temperature, and press the Silence/Reset key. Failure to acknowledge the Check Patient alarm by pressing the Silence/Reset key within the next 5 min causes the heater to shut down, and an alarm occurs. When operated in Baby Mode, the controller uses a skin temperature probe, connected between the controller input and the infant, to automatically adjust the heater output of the warmer module to maintain a selected set temperature. The Apgar Timer displays the elapsed time and sounds an alert tone at 1, 5, and 10 minutes. The Keypad Lock key, when pressed, enables or disables the Up/Down arrows, the Select Mode key, and the >37°C key. A procedural silence timer blocks out Low Baby Temp audible alarms for 5 minutes during routine procedures.

Blender Module (Optional) The blender module provides blended gas from 21% to 100% to the patient outlet on the resuscitation module.

Resuscitation Module (Optional) The resuscitation module contains pneumatic outlets necessary for infant resuscitation. Controls and displays for the module are located above the bassinet on the warmer column. Two variations of resuscitation modules exist: Resuscitation Module without Autobreath™ Infant Resuscitator and Resuscitation Module with Autobreath™. The Resuscitation Module has an adjustable airway pressure relief. NOTE: When pressure in the hose delivering gas to the patient falls below -0.4 kPa (-4 cm H2O), the one-way valve installed at the Patient Outlet connection opens. In the unlikely failure of the gas supply, the oneway valve allows patient to inspire room air. The resuscitation modules consist of the factory-installed components discussed on the following pages.

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PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Resuscitation Module without Autobreath™ Infant Resuscitator • Patient Outlet (Resuscitation Module only)-Use the Patient Outlet to provide continuous gas flow to the patient. Controls are provided for Airway Pressure Relief (maximum pressure) and Flow Rate (circuit flow delivering 100% oxygen or blended gas). The adjustable Airway Pressure Relief control is always operative when used with the 15 mm tubing provided. Pressure relief is adjustable and ranges from 0 to 4.9 kPa (0 to 50 cm H2O/mbar). The fixed internal safety relief valve is always operable and provides redundant maximum pressure relief at 5.9 kPa (60 cm H2O/mbar) ± 20% and allows the patient to inspire room air in the event of gas supply failure. The fixed internal safety relief valve provides a maximum pressure relief at 4.9 kPa (50 cm H2O/mbar) ± 20%. • Airway Pressure-The airway pressure gauge monitors the airway pressure when externally connected to patient circuits. (UK and other local variants are connected internally and may not have this fitting.) • Blender-The optional blender supplies blended gas only to the Patient Outlet in the Resuscitation Module. During operation, the resuscitation module alarms if both oxygen or air pressures are low. • Auxiliary Outlet-The Auxiliary Outlet supplies 100% oxygen through the Auxiliary Flow control to the auxiliary outlet connector. It is intended for oxygen enrichment of a manual bag resuscitator, for supplemental delivery to the patient, mother, or a second neonate, such as a twin. The Auxiliary Flow control adjusts the flow rate from 0 LPM to 15 LPM. An internal pre-set relief valve limits the auxiliary outlet pressure to 15.7 kPa (160.1 cm H2O/mbar). For the UK only: This internal pre-set relief valve limits the Aux Outlet pressure to 3.9 kPa (40 cm H2O/mbar). NOTE: The Auxiliary Outlet oxygen percentage is not adjustable. It always supplies 100% oxygen.

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PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 WARNING: The internal adjustable airway pressure relief is not functional with a self-inflating bag because the patient supply is connected to the fresh gas reservoir on the self-inflating bag rather than directly to the patient airway. When using a self-inflating bag, always use a suitable external airway pressure relief valve connected to the patient airway. To obtain maximum flow, turn the adjustable airway pressure relief knob to the Max. position. Failure to do so could result in infant injury WARNING: Using a breathing circuit other than the one supplied may inadvertently restrict the gas flow such that the indication of the gas flow and the adjustable airway pressure relief may be inaccurate. Infant injury could occur. • Patient breathing and supply circuits-Use the disposable patient supply circuit (PN 81 001 27/ MU10900) for manual bagging on the Resuscitation Module.

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PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Resuscitation Module with AutoBreath™ Infant Resuscitator WARNING: Always use an airway pressure monitor if the AutoBreath™ Infant Resuscitator is to be used unattended. Failure to do so could result in patient injury. • AutoBreath™ Infant Resuscitator-Use the AutoBreath™ Infant Resuscitator in conjunction with the continuous gas flow provided by the Patient Supply submodule. The AutoBreath™ Infant Resuscitator circuit is a gas-powered, time-cycled, continuous flow, pressurelimited resuscitator. It has a Rate (BPM) control and a fixed I/E ratio of 1:2 nominal. An On/Off switch allows the timing circuit to be turned on and off as needed. A PEEP control adjusts the Positive End Expiratory Pressure in the patient circuit. • Patient Gas Supply-The patient gas supply circuit may be used with the AutoBreath™ Infant Resuscitator turned on or off to provide continuous gas flow to the patient. Controls are provided for Airway Pressure Relief (maximum pressure) and Flow Rate (LPM) (circuit flow delivering 100% oxygen or blended gas). The adjustable Airway Pressure Relief control is always operative. A fixed internal safety valve is also provided and is also always operable. This valve provides redundant maximum pressure relief at 4.9 ± 1.0 kPa (50 cm H2O/mbar) and also allows the patient to inspire room air in the event of gas supply failure. Negative pressure is not available in the expiratory phase. NOTE: Flow Rate (LPM) is equivalent to flow meter. • Auxiliary Outlet-The auxiliary outlet supplies 100% oxygen through the Auxiliary Flow control to the auxiliary outlet connector. It is intended for oxygen enrichment of a manual bag resuscitator, for supplemental delivery to the patient, mother or second neonate, such as a twin. The Auxiliary Flow control adjusts the flow rate from 0 LPM to 15 LPM. An internal pre-set relief valve limits the auxiliary outlet pressure to 15.7 kPa (160.1 cm H2O/mbar). This internal pre-set relief valve limits the Aux Outlet pressure to 3.9 kPa (40 cm H2O/mbar). NOTE: Increasing back pressure may develop as the length of oxygen circuit tubing increases and tubing diameter decreases. Install oxygen delivery tubing as intended in a clinical situation and verify through flow measurement that approximately 15 LPM (maximum) can be achieved. NOTE: The Auxiliary Outlet oxygen percentage is not adjustable. It always supplies 100% oxygen.

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PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 WARNING: The internal adjustable airway pressure relief is not functional with a self-inflating bag because the patient supply is connected to the fresh gas reservoir on the self-inflating bag rather than directly to the patient airway. When using a self-inflating bag, always use a suitable external airway pressure relief valve connected to the patient airway. To obtain maximum flow, turn the adjustable airway pressure relief knob to the Max. position. Failure to do so could result in infant injury. WARNING: Using a breathing circuit other than the AutoBreath™ Infant Resuscitator Breathing Circuit (PN 81 000 19/ MU10850) may inadvertently restrict the gas flow such that the indication of the gas flow and the adjustable airway pressure relief may be inaccurate. Infant injury could occur. • Patient Breathing Circuits-Use the patient breathing circuit (PN 81 000 19/ MU10850) in conjunction with the AutoBreath™ Infant Resuscitator. Additionally, a patient supply circuit for manual bagging, or blow-by, (PN 81 001 26/ MU10899) may be used.

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