Dräger Resuscitaire WBR82 Instructions For Use Manual
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Dräger Resuscitaire WBR82 Instructions For Use Manual

Radiant warmer product
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Instructions for Use
Resuscitaire
WARNING
To properly use this medical device, read and
comply with these instructions for use.
Radiant Warmer Products
Models WBR82, RW82, and WMRW82

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Summary of Contents for Dräger Resuscitaire WBR82

  • Page 1 Instructions for Use Resuscitaire Radiant Warmer Products WARNING To properly use this medical device, read and Models WBR82, RW82, and WMRW82 comply with these instructions for use.
  • Page 2 This page intentionally left blank.
  • Page 3 Trademarks AutoBreath™ is a trademark of Draeger Medical Systems, Inc. Care-For-Me™ is a trademark of Draeger Medical Systems, Inc. CaviCide® is a registered trademark of Metrex Research Corporation. Critter Covers® is a registered trademark of Draeger Medical Systems, Inc. Nylok® is a registered trademark of Nylok LLC Delaware. Resuscitaire®...
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  • Page 5: Table Of Contents

    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 .
  • Page 6 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Standard Features ............2-16 Bassinet (Resuscitaire Birthing Room Warmer (WBR82) and Resuscitaire Radiant Warmer (RW82) only) .
  • Page 7 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Mounting of the Resuscitaire Wall Mounted Radiant Warmer (WMRW82)....4-13 Installing Accessories on 38-mm Poles ......... . 4-14 Operational Checkout Procedure .
  • Page 8 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Disassembly for Cleaning ............6-5 Assembly After Cleaning .

  • Page 9: Section 1: Symbol Definition And Intended Use

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Section 1 Symbol Definition and Intended Use Symbol Definition This manual contains different typefaces and symbols designed to improve readability and increase understanding of its content. Note the following examples: • Standard text—used for regular information. •...
  • Page 10 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 This product contains different symbols designed to increase understanding. Note the following examples: • This symbol indicates degree of protection against electric shock: Type BF: Degree of protection against electric shock: Type BF •...
  • Page 11 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 • This symbol indicates the Set Temperature keys: Set Temperature Keys • This symbol indicates the APGAR Timer keys: APGAR Timer Keys • This symbol indicates the Procedural Silence indicator: Procedural Silence Indicator •...
  • Page 12 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 • This symbol indicates “Castor locked.” Castor Locked • This symbol indicates “Castor unlocked.” Castor Unlocked • This symbol indicates “Steering Castor.” Steering Castor • This symbol indicates “Electrostatic discharge (ESD) sensitive part:” Electrostatics Discharge (ESD) Sensitive Part •...

  • Page 13: Dictionary Of Common Terms

    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: requires user intervention, usually includes an audible beep or series of beeps APGAR: named for Dr.
  • Page 14 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 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.

  • Page 15: Intended Use

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Intended Use Intended Use The Resuscitaire® Radiant Warmer is intended for thermoregulation, skin temperature monitoring, APGAR timing and resuscitation of newly born infants up to 10 kg. It is not intended for long term resuscitation or home use.
  • Page 16 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 This page intentionally left blank. 1 - 8...

  • Page 17: Section 2: Introduction, Features, And Specifications

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Section 2 Introduction, Features, and Specifications Introduction There are 3 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).

  • Page 18: Blender Module (Optional)

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 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 the alarm for 10 min, verify the infant temperature, and press the Silence/Reset key.
  • Page 19 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Resuscitation Module with Internal Pressure Manometer with 15 mm Fitting • Patient Outlet (Resuscitation Module with Internal Pressure Manometer and 15 mm Fitting only)—Use the Patient Outlet to provide continuous gas flow to the patient.
  • Page 20 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.
  • Page 21 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Resuscitation Module with External Pressure Manometer and 15 mm Fitting • Patient Outlet (Resuscitation Module with External Pressure Manometer and 15 mm Fitting only)—Use the Patient Outlet to provide continuous gas flow to the patient.
  • Page 22 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.

  • Page 23: Resuscitation Module With Autobreath™ Infant Resuscitator (Mu25178/Mu25179)

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Resuscitation Module with AutoBreath™ Infant Resuscitator WARNING: Do not leave the patient unattended when using the AutoBreath resuscitation module. Patient injury could occur. NOTE: The AutoBreath resuscitation feature provides resuscitation within the minimum patient weight/gestational age recommendations of the AAP guidelines (minimum weight >400 g or gestational age >23 weeks).
  • Page 24 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 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: At elevations above sea level, the respiratory rate decreases.

  • Page 25: Suction

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Suction A gas-powered, venturi-generated vacuum drives the suction circuit, which provides a negative pressure for suctioning the patient airway. This suction device is specifically intended for removal of mucus from neonates post delivery. The suction negative pressure is indicated on the suction gauge.

  • Page 26: Suction Line Filter

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Suction Line Filter The Suction Line Filter is a hydrophobic bacterial filter with extension tubing. It is connected in line with the supply connection to the suction bottle. The extension tubing connects to the suction bottle outlet port. Gas Supply Module (Optional) The gas supply module includes an On/Off switch that controls the pipeline and cylinder gas supply to the...

  • Page 27: Alarms

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Alarms All alarm indicators are displayed in the upper right corner of the controller panel and illuminate when activated. High Temperature When the skin probe is attached to the infant and the skin temperature exceeds 39 °C (102 °F), the heater automatically turns off, the High Temp indicator flashes, and the alarm sounds continuously.

  • Page 28: Blender Differential Bypass (Optional)

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Blender Differential Bypass (Optional) The factory-installed, optional, blender module alarms whenever the pressure differential between the oxygen and Air supplies exceed 207 kPa (30 psi) ± 14 kPa (2 psi). When this condition occurs, the blender continues to supply whichever gas has the higher pressure: either 100% air or 100% oxygen.

  • Page 29: Features Of The Resuscitaire Birthing Room Warmer (Wbr82)

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Features of the Resuscitaire Birthing Room Warmer (WBR82) NOTE: Suction bottle not shown. It is on the lower right side of the warmer column. 2 - 13...

  • Page 30: Features Of The Resuscitaire Birthing Room Warmer Without The Cart

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Features of the Resuscitaire Birthing Room Warmer without the Cart WARNING: For patient safety, the distances identified on the warmer column must be maintained to prevent underheating or overheating the infant. NOTE: Bassinet, mattress, panels, and optional equipment not shown on illustration. 2 - 14...

  • Page 31: Features Of The Resuscitaire Radiant Warmer (Rw82)

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Features of the Resuscitaire Radiant Warmer (RW82) Warmer head Controller Examination light Blender Suction Resuscitation module Gas supply module Bassinet, mattress and panels X-ray tray Handle Instrument tray Cylinder mounting Vari-Tilt bracket mechanism Pass-thru drawer Castor lock...

  • Page 32: Features Of The Resuscitaire Wall Mounted Radiant Warmer (Wmrw82)

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Features of the Resuscitaire Wall Mounted Radiant Warmer (WMRW82) Standard Features Bassinet (Resuscitaire Birthing Room Warmer (WBR82) and Resuscitaire Radiant Warmer (RW82) only) The bassinet provides maximum visibility and access to the infant. The bassinet tilts up in the rear to 5 ° and 10 °...
  • Page 33 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Optional Features (Resuscitaire Birthing Room Warmer (WBR82) and Resuscitaire Radiant Warmer (RW82) only) The following factory-installed options are available: Resuscitation module contains connections for: suction, patient (blended air/oxygen or oxygen), secondary gas delivery, and airway pressure gauge. Three variations of resuscitation modules exist: Resuscitation Module with Internal Pressure Manometer and 15 mm Fitting, Resuscitation Module with External Pressure Manometer, and Resuscitation Module with AutoBreath™.

  • Page 34: Accessories

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Accessories The following field-installed accessories are available (refer to Perinatal Care Accessories for additional parts): Description Organizer tray for pass-through drawer X-ray tray Shelf, fits either side (WBR82 only) I.V. pole fits either side (WBR82 only) I.V.

  • Page 35: Specifications

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Specifications Standard Features Feature Dimension POWER REQUIREMENTS 120 V Models 120 V, 50/60 Hz, 750 W (non-VHA), 1300 W (VHA) 230 V Models 230 V, 50/60 Hz, 750 W (non-VHA), 1300 W (VHA) OVERLOAD PROTECTION 120 V Models 10 A (non-VHA), 10 A (VHA)
  • Page 36 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Feature Dimension Height (RW82) 190.5 cm (75") Height w/VHA including Vari-tilt (RW82) maximum of 201 cm (maximum of 79") Bassinet Width (side-to-side) (RW82) 57.1 cm (22.5") Bassinet Depth (front-to-back) (RW82) 71.1 cm (28") Width (side-to-side) (WBR82) 71.1 cm (28") ≤...
  • Page 37 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Feature Dimension GAS USAGE EFFICIENCY Duration of Gas Supply Time per liter of cylinder volume × psi cylinderfactor --------------------------------------------------- - -------- - hours Example for E cylinder × 2200 0.28 123.2 ---------------------------- ------------ - 2hours5min Typical Cylinder Pressure 2200 psi nominal...

  • Page 38: Optional Features (Resuscitaire Birthing Room Warmer (Wbr82) And Resuscitaire Radiant

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Optional Features (Resuscitaire Birthing Room Warmer (WBR82) and Resuscitaire Radiant Warmer (RW82) only) Feature Dimension RESUSCITATION Wall Supply Pressure 40 psi (276 kPa) to 75 psi (517 kPa) Cylinder Pressure 3000 psi (20 684 kPa) maximum Infant Resuscitator Feature Patient Gas Supply Airway Pressure Limit, 0 cmH...
  • Page 39 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Feature Dimension NOTE: A 20 psi regulated 100% O source drives suction. Tubing 6 mm (0.25") inner diameter by 1.5 m (5') with sure-grip female molded connector ≤ 2 cmH Total Flow Resistance (without attachments, O @ 15 LPM subassemblies, or components added to the breathing system)

  • Page 40: Accessories (Wbr82 And Rw82 Only)

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Accessories (WBR82 and RW82 only) Feature Dimension Infusion Support Weight Capacity (RW82 3 kg (6.6 lb) maximum only) Shelf Weight Limit (WBR82 only) 4.5 kg (10 lb) maximum Shelf Dimensions (WBR82 only) 35.6 cm (14.0") x 30.5 cm (12.0") X-ray Tray Weight Limit 2.2 kg (4.5 lb) maximum X-ray Tray Dimensions...

  • Page 41: Alarms

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Alarms Feature Specification High Temperature Activates if the skin probe is attached and the skin probe reaches 39.0°C ±0.2°C (102.2°F). Resets at 38.5°C (101.3°F). Check Patient Activates in Manual Mode after 10 min. Remains on with acoustic alarm signal every 30 s for 5 min for a total of 15 min.

  • Page 42: Standards Compliance

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Standards Compliance EN 60601-1: 1990/A1:1993 Medical Electrical Equipment, Part 1: General IEC 60601-1: 1988/A1:1991/A2:1995 Requirements for Safety EN 60601-1-2—2001/A1:2006 Medical Electrical Equipment, Part 1-2: General IEC 60601-1-2:2001/A1:2004 Requirements for Safety - Collateral Standard: Electromagnetic Compatibility—Requirements and Tests EN 60601-2-21: 1994/A1—1996...

  • Page 43: Electromagnetic Compatibility (Emc) Guidance And Manufacturer Declarations

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Electromagnetic Compatibility (EMC) Guidance and Manufacturer Declarations Guidance and Manufacturer Declaration—Electromagnetic Emissions The Resuscitaire Radiant Warmers are 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 Electromagnetic Environment—Guidance...
  • Page 44 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Guidance and Manufacturer Declaration—Electromagnetic Immunity The Resuscitaire Radiant Warmers are 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. IEC 60601 Test Electromagnetic Environment—...
  • Page 45 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Guidance and Manufacturer Declaration—Electromagnetic Immunity Resuscitaire Radiant Warmers are intended for use in the electromagnetic environment specified below. The cus- tomer or user of the unit should ensure that the unit is used in such an environment. Immunity IEC 60601 Compliance...
  • Page 46 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Resuscitaire Radiant Warmers The Resuscitaire Radiant Warmers are intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the unit can help prevent electromagnetic interference (EMI) by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the unit as recommended, according to the maximum output power of the communications equipment.

  • Page 47: Section 3: Precautions And Safety Tips

    PROPRIETARY AND CONFIDENTIAL DRAFT 8 Jan 04 Section 3 Precautions and Safety Tips Precautions Latex may cause an allergic reaction in some patients and caregivers. CAUTION: Federal Law (U.S.) restricts this device to sale by or on the order of a physician. WARNING: Only properly trained personnel, as directed by an appropriately qualified physician aware of currently known risks, should use infant radiant warmers.
  • Page 48 PROPRIETARY AND CONFIDENTIAL DRAFT 8 Jan 04 WARNING: For effective heating, ensure that the warmer module is centered above the patient. Failure to do so could result in personal injury. WARNING: The radiant warmer cannot sense the correct temperature of the patient when the skin probe is disconnected from the patient skin.
  • Page 49 PROPRIETARY AND CONFIDENTIAL DRAFT 8 Jan 04 WARNING: Do not place objects between the infant and the warmer module that block heat transfer and absorb heat. The heater will heat the objects instead of the patient. Patient injury could occur. WARNING: Air currents across the bassinet area affect patient thermal balance.

  • Page 50: Electrical Precautions

    PROPRIETARY AND CONFIDENTIAL DRAFT 8 Jan 04 WARNING: When raising or lowering the upper post of the variable height warmer, ensure that any attached cables, tubing, or hoses are not compromised. Patient or personal injury, or equipment damage could occur. WARNING: Risk of equipment damage and risk of injury.

  • Page 51: Oxygen Precautions

    PROPRIETARY AND CONFIDENTIAL DRAFT 8 Jan 04 Oxygen Precautions WARNING: Improper use of supplemental oxygen is associated with serious side effects, including blindness, brain damage, and death. The risks vary with each infant. The attending physician must prescribe all clinical practices regarding oxygen administration. WARNING: Compressed gas cylinders, such as oxygen cylinders, can become hazardous projectiles if the gas is released rapidly.

  • Page 52: Low-Flow Microblender Precautions

    PROPRIETARY AND CONFIDENTIAL DRAFT 8 Jan 04 WARNING: On high-pressure oxygen cylinders, use only pressure regulators or reducing valves approved for oxygen service. Do not use oxygen pressure regulators or reducing valves for air or gases other than oxygen as they may be hazardous. Operate such devices in strict accordance with the manufacturer recommendations.

  • Page 53: Resuscitation Precautions (Common To All Modules)

    PROPRIETARY AND CONFIDENTIAL DRAFT 8 Jan 04 WARNING: Use air inlet water filters with the low-flow microblender. Replace them in accordance with the manufacturer recommendation. Failure to do so could result in patient injury or equipment damage. WARNING: Monitor the concentration of oxygen provided and the partial pressure of oxygen in the patient blood (PaO ).
  • Page 54 PROPRIETARY AND CONFIDENTIAL DRAFT 8 Jan 04 WARNING: When using the Patient Outlet, use the 10-mm tubing offered by the manufacturer, or use infant resuscitation bags with built-in pressure release during infant resuscitation. Failure to do so could result in patient 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...
  • Page 55 PROPRIETARY AND CONFIDENTIAL DRAFT 8 Jan 04 WARNING: During a gas failure, the patient only gets room air from the two-way relief valve on the Patient Supply Resuscitation Module. Breathing room air through the two-way relief valve requires extra effort. If this condition occurs, correct the gas failure as soon as possible. Failure to do so could result in patient injury.

  • Page 56: Resuscitation Precautions Precautions (Mu25175, Mu25180, And Autobreath™ Infant Resuscitator)

    PROPRIETARY AND CONFIDENTIAL DRAFT 8 Jan 04 WARNING: Risk of patient injury. Do not add attachments to the breathing system. Adding attachments may change module performance. WARNING: If the resuscitation module is used at altitudes significantly above sea level, ensure that all resuscitation controls are properly calibrated.

  • Page 57: Resuscitation Precautions (Autobreath™ Infant Resuscitator)

    PROPRIETARY AND CONFIDENTIAL DRAFT 8 Jan 04 Resuscitation Precautions (AutoBreath™ Infant Resuscitator) NOTE: Read ALL resuscitation precautions before operating the AutoBreath Infant Resuscitator. WARNING: For MU11372, Patient Outlet 2 Gas Supply Pressure is internally limited to 3.9 kPa (40 cmH O).

  • Page 58: System Precautions

    PROPRIETARY AND CONFIDENTIAL DRAFT 8 Jan 04 System Precautions Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards (e.g. IEC950 for data processing equipment and IEC60601-1 for medical equipment). Furthermore, all configurations must comply with the systems standard IEC60601-1-1.

  • Page 59: Safety Tips

    PROPRIETARY AND CONFIDENTIAL DRAFT 8 Jan 04 CAUTION: Castors do not control all the Electro Static Discharge (ESD) characteristics of the device on which they are mounted. They do, however, help prevent the build-up of charge on the castors from friction during motion. ESD is a product of the environment and only the user/owner can control the ESD in that environment by maintaining a conductive floor, equipping employees with ESD clothing and control devices, etc.
  • Page 60 PROPRIETARY AND CONFIDENTIAL DRAFT 8 Jan 04 WARNING: Protect the infant eyes from strong light from the examination lamp. Failure to do so could result in patient injury. WARNING: All panels must be erect and secure during transport. Failure to do so could result in patient injury.
  • Page 61 PROPRIETARY AND CONFIDENTIAL DRAFT 8 Jan 04 WARNING: Changing the mattress level from horizontal to Trendelenburg or reverse Trendelenburg can affect performance of the radiant warmer. Monitor the temperature of the patient. Failure to do so could result in patient injury. WARNING: When placing a patient on the warmer mattress, immediately change from Pre-Warm Mode to either Manual Mode or Baby Mode.
  • Page 62 PROPRIETARY AND CONFIDENTIAL DRAFT 8 Jan 04 CAUTION: This product is designed to comply with Electromagnetic Compatibility requirements. However, potential electromagnetic or other interference may exist. If interference is observed, move the equipment or identify the source of the interference and take appropriate action. Failure to do so could result in equipment damage.

  • Page 63: Section 4: Installation And Assembly

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Section 4 Installation and Assembly Installation The Resuscitaire Birthing Room Warmer (WBR82) is shipped in two cartons. One carton contains the cart and bassinet. The other carton contains the following assemblies: • Upper post assembly •...

  • Page 64: Assembly Of The Resuscitaire Birthing Room Warmer (Wbr82)

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Assembly of the Resuscitaire Birthing Room Warmer (WBR82) CAUTION: When removing the equipment from the carton, use care not to scratch or otherwise damage unprotected surfaces. Warmer 1. If a monitor shelf is desired on the unit, install the weights provided with the monitor shelf in the bottom of the lower post.
  • Page 65 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 11. Install, but do not tighten, the two #10-32 x 3/8" Nylok screws (H) in the upper holes on the inside of the upper post (D). 12. Slowly lower the warmer (I) onto the upper post (D). Align the slots (J) of the warmer under the two #10-32 x 3/8"...
  • Page 66 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 21. Secure the lower rear cover (O) to the upper post using the six #10-32 x ¾" white screws (P). 22. Secure the upper rear cover (Q) to the upper post using the four #10-32 x ¾" white screws (R). 23.

  • Page 67: Cart And Bassinet

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 26. Secure the mounting blocks (W) to the sides of the column by installing the two #10-32 x 2.6" cross head screws through the two #10 lockwashers, the mounting holes (X) in the rear handle and the two mounting blocks.

  • Page 68: Assembly Of The Resuscitaire Radiant Warmer (Rw82)

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Assembly of the Resuscitaire Radiant Warmer (RW82) NOTE: The mounting hardware is stored in a bag in the pass-through drawer. Warmer 1. Remove the two #8-32 x ¾" screws (A) that secure the controller (B) to the head support plate (C).
  • Page 69 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 4. Lift the upper post (D) and slide it into the slot at the base of the column (E) on the bassinet/cart assembly. CAUTION: Do not kink the suction hoses. Equipment malfunction could occur. 5.
  • Page 70 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 8. Install and turn, but do not tighten, the two #10-32 x 3/8" Nylok screws (K) in the upper holes on the inside of the upper post (D). 9. Slowly lower the warmer (L) onto the upper post. Align the slots (M) of the warmer under the two #10- 32 x 3/8"...
  • Page 71 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 18. Secure the lower rear cover (S) to the upper post (D) and the bassinet/cart assembly using the ten #10-32 x 3/8" screws (T). 19. Secure the upper rear cover (U) to the upper post using the four #10-32 x 1/2"...
  • Page 72 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 21. Install the front-end panel: a. Slide the front-end panel (AA) into the front of the bassinet assembly until its release tabs (BB) catch. b. Raise the front-end panel to its fully raised position.

  • Page 73: Assembly Of The Resuscitaire Wall Mounted Radiant Warmer (Wmrw82)

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Assembly of the Resuscitaire Wall Mounted Radiant Warmer (WMRW82) WARNING: The wall mount bracket installation must be appropriately certified that it meets or exceeds the pull-out force before mounting the Resuscitaire Wall Mounted Radiant Warmer. Failure to do so can result in an unsafe installation that could cause equipment damage or personal or patient injury.
  • Page 74 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 NOTE: Ensure that the thick end of the wall mount plate is facing the top of the modified post. 4. Install, but do not tighten, the two #10-32 x 3/8" screws (J) in the upper holes on the inside of the modified post.

  • Page 75: Mounting Of The Resuscitaire Wall Mounted Radiant Warmer (Wmrw82)

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Mounting of the Resuscitaire Wall Mounted Radiant Warmer (WMRW82) WARNING: The wall mount bracket installation must be appropriately certified that it meets or exceeds the pull-out force before mounting the Resuscitaire Wall Mounted Radiant Warmer. Failure to do so can result in an unsafe installation that could cause equipment damage or personal or patient injury.

  • Page 76: Installing Accessories On 38-Mm Poles

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 2. Install the wall bracket mounting bolts in the wall leaving 1/2" of the mounting bolts exposed. NOTE: The recommended wall bracket mounting bolts are 5/16" diameter. Four bolts are required, but are not supplied with the equipment.

  • Page 77: Operational Checkout Procedure

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Operational Checkout Procedure Perform the operational checkout procedure before each use and after disassembly for cleaning, servicing, or maintenance. If the unit does not perform properly, do not use it and refer it to qualified service personnel.
  • Page 78 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 d. The Heater Power indicator reduces to three segments (30%). 6. Check Manual Mode: a. Select Manual Mode by pressing the Mode Select key. The Manual indicator lights. b. Press the Up arrow key until all of the Heater Power display segments light. c.

  • Page 79: Mechanical Operation

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 10. Check the Probe alarm: a. Disconnect the skin probe from the skin probe connector. The Baby Temperature display goes off, the Probe indicator flashes, and the alarm sounds. b. Connect the skin probe to the skin probe connector. 11.
  • Page 80 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 2. Check the Vari-tilt control (Resuscitaire Radiant Warmer only): a. Rotate the Vari-tilt knob in the front of the bassinet clockwise through the entire range from 0 ° to 10 °. b. Rotate the Vari-tilt knob in the front of the bassinet counter-clockwise through the entire range from 0 °...
  • Page 81 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 5. Check the pass-through drawer (Resuscitaire Birthing Room Warmer shown): a. Slide the pass-through drawer in and out on both sides of the cart and bassinet. b. Return the pass-through drawer to its center position.
  • Page 82 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 8. Check the writing surface (Resuscitaire Birthing Room Warmer only): a. Pull the writing surface out from under the bassinet. b. Return the writing surface to under the bassinet. 9. Check the cart and bassinet docking mechanism and castor locks (Resuscitaire Birthing Room Warmer only).

  • Page 83: Resuscitation Equipment (Optional)

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Resuscitation Equipment (Optional) Gas Source Pressure 1. Ensure that the oxygen and air pipelines are securely attached to the appropriate fittings on the rear of the unit. Also ensure that the gas supply present is 276 kPa (40 psi) to 517 kPa (75 psi). 2.
  • Page 84 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Suction CAUTION: To keep the suction tube from being blocked or damaged when installing a disposable suction bottle, position the outlet port parallel to the plate. Avoid kinking of tubing. Equipment damage could occur. 1.

  • Page 85: Resuscitation Module (Optional)

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Resuscitation Module (Optional) WARNING: For prolonged resuscitation, use a heat and moisture exchanger or heated humidification. Failure to do so could result in patient injury. Patient Supply with the 15 mm Outlet For manual resuscitation, use the 15 mm Patient Supply Circuit or the Infant Breathing Circuit.
  • Page 86 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 b. Insert a “T” fitting with an airway pressure monitor into the Patient Outlet port. Connect it to the Airway Pressure port to indicate the breathing circuit pressure. Adjust the Airway Pressure Relief control as necessary. NOTE: The ability of the adjustable airway pressure relief valve to limit pressure is dependent on the flow rate of gas.

  • Page 87: Resuscitation Module With Autobreath™ Infant Resuscitator (Optional)

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Resuscitation Module with AutoBreath™ Infant Resuscitator (Optional) WARNING: Always monitor the airway pressure, and set appropriate pressure relief during infant resuscitation. Failure to do so could result in patient injury. Automatic Patient Circuit with 15 mm Outlet For automatic resuscitation, use the Automatic Patient Circuit (10-mm tubing with exhalation valve and exhalation valve control line tubing).

  • Page 88: Blended Gas Supply (Optional)

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 14. The result should be the desired breaths per minute (bpm) ± 10%. To check inspiratory and expiratory resistance, measure flow and pressure at the patient connection port. Resistance must not exceed 0.6 kPa (6 cmH O) at 5 LPM.

  • Page 89: Section 5: Instructions For Use

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Section 5 Instructions for Use Instructions for Use Controls, Indicators, and Connectors Controller Front Panel Controls, Indicators, and Connectors Name Description Power key Press to switch on or off the controller and the warmer module. Baby Temperature display Digital display of the infant temperature in °C or °F, whether in Manual or Baby Mode.
  • Page 90 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Name Description °C/°F key Press to select °C or °F for the Baby Temperature and Set Tem- perature displays. >37 °C indicator Lights to indicate that the Temperature Override Mode is selected. >37 °C key Press to place the Set Temperature display in Temperature Override Mode.
  • Page 91 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Name Description High Temp alarm indicator When the skin probe is attached to the infant and the skin temper- ature exceeds 39.0°C (102.2°F), the indicator flashes, the alarm sounds continuously, and the heater turns off. To silence the alarm for 2 min, press the Silence/Reset key.
  • Page 92 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Name Description Silence/Reset key Has three functions: silences alarms, resets Manual Mode, and sets procedural silence. If an alarm sounds in Manual Mode, press to silence the High Temp alarm for 2 min, reset the Chk Patient alarm, and silence the Chk Patient alarm at any time after 10 min.
  • Page 93 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Controller Rear Panel Controls and Connectors Name Description Circuit breaker Turns the controller on and off when switched by the operator or when excessive system current exists. Power Accepts the AC power cable. Auxiliary port Data port for connection to a printer or host computer system.
  • Page 94 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Power Outlet to the Controller Name Description Power outlet Outlet is used to connect the AC power cable from the lower post to the controller. Controls for the VHA Stand (RW82) Name Description VHA height adjust pedals To adjust the height of the bed, press the up/down arrow (A) on the pedal of the VHA stand.
  • Page 95 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Blended Gas Supply Control Name Description Blender % Oxygen control Blends the air and oxygen mixture from 21% to 100% oxygen to the primary patient outlet. NOTE: The Blender Module option changes the Resuscitation Module to add the air pipeline, the cylinder connections.
  • Page 96 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Resuscitation Module Controls, Indicators, and Connectors The actual display may differ in appearance or configuration. Name Description Suction gauge Displays the suction level from 0 mmHg (0 cmH O) to 200 mmHg (107 cmH O) of vacuum.
  • Page 97 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Resuscitation Module with AutoBreath™ Infant Resuscitator Controls, Indicators, and Connectors Name Description Suction gauge Displays the suction level from 0 mmHg (0 cmH O/mbar) to 200 mmHg (107 cmH O/mbar) of vacuum. Suction control Adjusts the suction level from 0 mmHg (0 cmH O/mbar) to 150 mmHg (80 cmH...
  • Page 98 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Name Description Patient Outlet connector Accepts the patient circuit outlet line. Accepts the breathing circuits (MU10850/MU10841). If the blender option is incorporated, it delivers the blended gas. Airway pressure port Connects the airway pressure gauge to the patient breathing circuit.

  • Page 99: Resuscitation Module

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Resuscitation Module 1. To use the Suction feature, turn it on using the On/Off switch. NOTE: The gas supply must be turned on. 2. To adjust suction from 0 kPa to -19.99 kPa, use the Suction control knob.

  • Page 100: Controller

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Controller SHOCK HAZARD: Plug the power cable only into a properly grounded wall receptacle that is approved for hospital use and of the correct voltage. Do not use extension cords or an AC receptacle box for this device.
  • Page 101 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 NOTE: Use Manual Mode only for short-term warming with nursing personnel in constant attendance. NOTE: The patient end of the skin probe must be attached or a probe alarm occurs. This alarm indicates a difference of 0.4°C between the two thermistors in the skin probe.

  • Page 102: Baby Mode

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Baby Mode Use Baby Mode for long-term warming. In the Baby Mode, a skin probe placed on the infant abdomen measures the infant skin temperature. The radiant warmer in Baby Mode operates in servo control, or closed loop control.
  • Page 103 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 WARNING: Use only the skin probes with reflective probe covers supplied by the manufacturer. Failure to do so could result in patient injury or equipment damage. WARNING: Do not place objects between the infant and the warmer module that block heat transfer and absorb heat.

  • Page 104: Examination Light

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 NOTE: To minimize the effect of direct radiation on the skin probe and to obtain a more accurate baby temperature measurement, cover the sensor with a cover. Appropriate covers include Critter Covers Probe Cover, Care-For-Me™ Cover, or equivalent insulating foam or gel covers with a reflective surface facing the warmer module.

  • Page 105: Cart And Bassinet

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Cart and Bassinet End and Side Panels CAUTION: Do not attempt to move the cart and bassinet by using the acrylic end and side panels as a handle. Use the rear handle when moving the equipment. Equipment damage could occur. WARNING: When the panels are down, do not leave the infant unattended.

  • Page 106: Vari-Tilt Control

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 2. Place the bassinet in the 5 ° or 10 ° Trendelenburg position. WARNING: When transporting the infant in the cart and bassinet, place the mattress in the horizontal position rather than tilted. Failure to do so could result in personal injury. 3.

  • Page 107: X-Ray Tray Accessory (Optional)

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 X-Ray Tray Accessory (Optional) 1. To install an x-ray cassette, perform the following: a. Swing the warmer module to the right or left of center as required to position the x-ray device. b. Lift the left or right bassinet side panel up. c.

  • Page 108: Universal Cylinder Bracket

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Universal Cylinder Bracket CAUTION: When installing the cylinder, ensure that the universal cylinder bracket aligns the outlet of the cylinder with the gas inlet on the back of the unit. Injury or equipment damage could occur. The universal cylinder bracket can be adjusted to secure the cylinder in the proper position.

  • Page 109: Section 6: Cleaning, Maintenance, Replacement Parts, And Storage And Handling

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Section 6 Cleaning, Maintenance, Replacement Parts, and Storage and Handling Cleaning WARNING: Follow the product manufacturer instructions. Failure to do so could result in patient injury, personal injury, or equipment damage. WARNING: If oxygen is in use, ensure that the oxygen supply to the equipment is switched off and disconnected from the oxygen supply during cleaning and maintenance procedures.

  • Page 110: General Cleaning

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 General Cleaning At a minimum, thoroughly clean and disinfect the radiant warmer upon discharge of an infant. However, depending upon individual facility policy, perform this procedure as often as daily, if desired. To most effectively clean the unit, disassemble the unit and then group the parts in categories according to the method of cleaning required (see “Disassembly for Cleaning”...

  • Page 111: Cleaning Clear Plastic And Acrylic Surfaces

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Cleaning Clear Plastic and Acrylic Surfaces CAUTION: Do not use alcohol, acetone, or any organic solvents for cleaning. Alcohol can cause crazing of plastic and acrylic. CAUTION: Do not expose plastic and acrylic to direct radiation from germicidal lamps. Ultraviolet radiation from these sources can cause cracking and crazing of clear plastic and acrylic.

  • Page 112: Cleaning The Reusable Suction Bottle

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Cleaning the Reusable Suction Bottle CAUTION: Do not flash autoclave the glass bottle. Equipment damage could occur. 1. Discard the filter and tubing. 2. Use an EPA-registered disinfectant-detergent, such as cold sterilants and quarternary ammonium compound disinfectants to soak the bottle and cap assembly.

  • Page 113: Disassembly For Cleaning

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Disassembly for Cleaning 1. Pull both bassinet side panels straight up, and remove them from the unit. 2. Remove the bassinet back panel: a. Raise the bassinet back panel straight up until the bottom pins are next to the slots in the corner brackets.
  • Page 114 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 c. Pull the bassinet front panel straight out, and remove it from the unit. 4. Remove the mattress from the bassinet. 5. Remove the x-ray tray. 6. Open the door (if installed) and remove the suction bottle and filter from the left side of the column or from the front of the bassinet.

  • Page 115: Assembly After Cleaning

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Assembly After Cleaning 1. Return the mattress to the bassinet. 2. Return the x-ray tray. 3. Insert the pins of the bassinet back panel in the corner brackets, and return it to the unit. 4.

  • Page 116: Maintenance

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Maintenance WARNING: Risk of electric shock. Service personnel could be injured by electric shock. Before servicing work is carried out, disconnect all electrical and gas connections from voltage and gas supply systems. WARNING: Risk of injury or equipment damage.

  • Page 117: Calibration

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Maintenance Intervals Replaceable parts: Mattress Users and service personnel Skin probes Users and service personnel Probe covers Users and service personnel Suction bottle Users and service personnel Maintenance: Device servicing and main- Service personnel tenance Replace Oxygen hose (wall Users and service personnel...

  • Page 118: Pneumatic System

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Pneumatic System Pneumatic System Block Diagram 6 - 10...

  • Page 119: Replacement Parts

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Replacement Parts For a list of parts that a user can replace, refer to the table on page 6-9. Refer to Perinatal Care Accessories Catalog for additional parts. Service personnel must replace parts not listed. Part Number Description MU20503...

  • Page 120: Disposal

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Part Number Description MU11873 I.V. pole (WBR82 only) MU10637 I.V. pole adapter (WBR82 only) MU21277 Kit, Cylinder bracket assembly (WBR82 only) MU12085 Basket assembly (WBR82 only) 2M21514 Infusion support (RW82 only) 2M21186 Adjustable utility shelf (RW82 only) MU21260 Scale MU01732...

  • Page 121: Section 7: Troubleshooting

    PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Section 7 Troubleshooting Troubleshooting WARNING: Only facility-authorized personnel must troubleshoot the Resuscitaire Radiant Warmer products. Troubleshooting by unauthorized personnel could result in personal injury or equipment damage. For troubleshooting of the equipment, refer to the table on page 7-1. If you cannot localize the fault, remove the unit from use, and refer it to factory-trained or other qualified service personnel.
  • Page 122 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Symptom Possible Cause Corrective Action Oxygen or air pressures are low. Adjust oxygen or air pressure to correct setting. Both cylinders may not be Check cylinder gauge. opened. Pressure differential between the Adjust oxygen or air pressure to oxygen and Air supplies exceed correct setting.
  • Page 123 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 Symptom Possible Cause Corrective Action The Inspiratory/Expiratory (I/E) Resuscitation Module has failed. Replace the resuscitation mod- Ratio is Greater Than 1:2.4 and ule or refer the unit to service. Less Than 1.6:1, 1:1. 7 - 3...
  • Page 124 PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 This page intentionally left blank. 7 - 4...
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  • Page 126 These Instructions for Use only apply to Resuscitaire Radiant Warmer Products Models RW82, WBR82 and WMRW82 with the Serial No.: Without Serial No. filled in by Dräger, these instructions for use are provided for general information only and do not apply to a specific medical device.

This manual is also suitable for:

Resuscitaire rw82Resuscitaire wmrw82

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