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PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04

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Standards Compliance

EN 60601-1: 1990/A1:1993
IEC 60601-1: 1988/A1:1991/A2:1995

Medical Electrical Equipment, Part 1: General
Requirements for Safety

EN 60601-1-2—2001/A1:2006
IEC 60601-1-2:2001/A1:2004

Medical Electrical Equipment, Part 1-2: General
Requirements for Safety - Collateral Standard:
Electromagnetic Compatibility—Requirements
and Tests

EN 60601-2-21: 1994/A1—1996
IEC 60601-2-21:1994/A1—1996

Medical Electrical Equipment, Part 2: Particular
Requirements for the Safety of Radiant Warmers

CAN/CSA C22.2 No. 601.1—M90
CAN/CSA C22.2 No. 601.1.21-98

Medical Electrical Equipment, Safety Require-
ments for Medical Electrical Systems

EN 50419

Directive 2002/96/EC of the European Parliament
and of the Council of 2003-01-27 on Waste Elec-
trical and Electronic Equipment (WEEE) Annex
IV

EN794-1:1997

Lung ventilators, Part 1: Particular requirements
for critical care ventilators, including Amendment
1: 2000

NOTE:

Does not apply to the Resuscitaire Wall Mounted
Radiant Warmer (WMRW82) only because it is not
equipped with resuscitation or suction equipment.

EN10079-3:1999

Medical suction equipment - Part 3: Suction equip-
ment powered from a vacuum or pressure source

NOTE:

Does not apply to the Resuscitaire Wall Mounted
Radiant Warmer (WMRW82) only because it is not
equipped with resuscitation or suction equipment.

EN12342: 1998

Breathing tubes intended for use with anesthetic
apparatus and ventilators

NOTE:

Does not apply to the Resuscitaire Wall Mounted
Radiant Warmer (WMRW82) only because it is not
equipped with resuscitation or suction equipment.

ISO14971: 2007

Medical devices, Application of risk management
to medical devices

ISO 10651-5: 2006

Lung ventilators for medical use: Particular
requirements for basic safety and essential perfor-
mance — Part 5:Gas-powered emergency resusci-
tators

Содержание RW82

Страница 1: ...WARNING To properly use this medical device read and comply with these instructions for use Radiant Warmer Products Models WBR82 RW82 and WMRW82 Instructions for Use Resuscitaire ...

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Страница 3: ...rex Research Corporation Critter Covers is a registered trademark of Draeger Medical Systems Inc Nylok is a registered trademark of Nylok LLC Delaware Resuscitaire is a registered trademark of Draeger Medical Systems Inc SoftBed is a trademark of Dräger Medical GmbH Vari tilt is a trademark of Draeger Medical Systems Inc VentStar is a trademark of Dräger Medical GmbH ...

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Страница 5: ... with 15 mm Fitting with Internal Pressure Manometer MU25175 MU25180 2 3 Resuscitation Module with 15 mm Fitting with External Pressure Manometer MU25176 2 5 Resuscitation Module with AutoBreath Infant Resuscitator MU25178 MU25179 2 7 Suction 2 9 Suction Line Filter 2 10 Gas Supply Module Optional 2 10 Apgar Timer 2 10 Weigh Scale 2 10 Alarms 2 11 High Temperature 2 11 Check Patient 2 11 Probe 2 1...

Страница 6: ...gnetic Compatibility EMC Guidance and Manufacturer Declarations 2 27 Section 3 Precautions and Safety Tips Precautions 3 1 Electrical Precautions 3 4 Explosion Precautions 3 4 Oxygen Precautions 3 5 Low Flow Microblender Precautions 3 6 Resuscitation Precautions Common to All Modules 3 7 Resuscitation Precautions Precautions MU25175 MU25180 and AutoBreath Infant Resuscitator 3 10 Resuscitation Pre...

Страница 7: ... Pre Warm Mode 5 12 Manual Mode 5 12 Baby Mode 5 14 Examination Light 5 16 Cart and Bassinet 5 17 End and Side Panels 5 17 Bassinet Tilt Control 5 17 Vari tilt Control 5 18 Docking and Undocking Resuscitaire Birthing Room Warmer WBR82 only 5 18 X Ray Tray Accessory Optional 5 19 Universal Cylinder Bracket 5 20 Section 6 Cleaning Maintenance Replacement Parts and Storage and Handling Cleaning 6 1 G...

Страница 8: ...IAL DRAFT 5 Feb 04 iv Disassembly for Cleaning 6 5 Assembly After Cleaning 6 7 Maintenance 6 8 Calibration 6 9 Repair 6 9 Pneumatic System 6 10 Replacement Parts 6 11 Disposal 6 12 Section 7 Troubleshooting Troubleshooting 7 1 ...

Страница 9: ... information or important instruction clarification This symbol highlights a WARNING Warning A WARNING identifies situations or actions that affect patient or user safety Disregarding a warning could result in patient or user injury This symbol highlights a CAUTION Caution A CAUTION points out special procedures or precautions that personnel must follow to avoid equipment damage This symbol highli...

Страница 10: ...disposable suction bottle Disposable Suction Bottle This symbol indicates a reusable suction bottle with suction line filter Reusable Suction Bottle This symbol indicates a patient Patient This symbol indicates the Suction Line Filter Suction Line Filter This symbol indicates the Power On Off key Power On Off Key This symbol indicates the Celsius Fahrenheit Selection key Celsius Fahrenheit Selecti...

Страница 11: ...edural Silence indicator Procedural Silence Indicator This symbol indicates the Silence Reset key Silence Reset Key This symbol indicates the Mode Select key Mode Select Key This symbol indicates the Keypad Lock key Keypad Lock Key This symbol indicates the Examination Light key Examination Light Key This symbol indicates Phthalate present Phthalate Present This symbol indicates Do not reuse Do No...

Страница 12: ...es Steering Castor Steering Castor This symbol indicates Electrostatic discharge ESD sensitive part Electrostatics Discharge ESD Sensitive Part This symbol indicates Electromagnetic interference Electromagnetic Interference This symbol indicates Protective earth ground Protective Earth Ground This symbol indicates Fuse Fuse This symbol indicates Weight limit Weight Limit ...

Страница 13: ...ured by a flow meter Foot Candle measurement of light and the relative illumination of a surface GMDN Global Medical Device Nomenclature Hyperthermia patient is too hot hyper too much thermia heat Hypothermia patient is too cold hypo not enough thermia heat I E Inspiratory Expiratory Manual Mode warmer temperature control mode where clinicians determine the heater output to the infant manually Not...

Страница 14: ...ured 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 Trendelenburg elevating one end of the mattress UMDNS Universal Medical Device Nomenclature System ...

Страница 15: ...ghing up to a maximum of 10 kg It is not intended for home use Environment of Use Resuscitaire is designed for use anywhere labor and delivery may occur within a health care facility Indications Contraindications 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 t...

Страница 16: ...PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 1 8 This page intentionally left blank ...

Страница 17: ...ing 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 Fold the side and front panels down to gain access to the ...

Страница 18: ...st is completed Refer it to qualified service personnel Failure to do so could result in patient injury or equipment damage WARNING Do not place the device into use if any indicator fails to light or any segments of the digital display fails to light or any audible tone fails to sound Refer it to qualified service personnel Failure to do so could result in patient injury or equipment damage Blende...

Страница 19: ...the Patient Outlet connection This valve opens when pressure in the hose delivering the gas to the patient falls below 0 4 kPa 0 06 psi NOTE Adjust flow rate to between 5 LPM and 15 LPM Blender The optional blender supplies blended gas to the Patient Outlets in the Resuscitation Module During operation an alarm indicates if either oxygen or air pressures are low Patient Outlet 2 Patient Outlet 2 s...

Страница 20: ...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 are inaccurate Patient injury could occur Patient breathing and supply circuits Use the disposable breathing circuit MP00310 on the Resuscitation Module NOTE VentStar Resuscitaire disposable...

Страница 21: ...valve opens when pressure in the hose delivering the gas to the patient falls below 0 4 kPa 0 06 psi NOTE Adjust flow rate to between 5 LPM and 15 LPM Airway Pressure The airway pressure gauge monitors the airway pressure when externally connected to patient circuits Blender The optional blender supplies blended gas only to the Patient Outlets in the Resuscitation Module During operation the resus...

Страница 22: ...ay 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 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 are inaccurate Pati...

Страница 23: ...tient 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 cmH2O mbar The valve also allows the patient to...

Страница 24: ...PM to 15 LPM 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 ...

Страница 25: ... the maximum suction pressure to 150 mmHg 80 cm H2O mbar This suction module contains an On Off switch and a suction control knob The suction control knob provides suction adjustment between 0 to 19 99 kPa 0 to 2 90 psi minimum of 16 LPM at maximum NOTE The disposable suction bottle has a built in filter Disposable suction bottle 800 mL MU10918 and the associated filter MU10915 WBR82 only Reusable...

Страница 26: ...h the highest pressure Check cylinder gauges to determine gas source On units equipped with the blender module oxygen and air pressure gauges are provided NOTE The Blender Module option changes the Resuscitation Module to add the air pipeline and the cylinder connections It also adds an air gauge to the Gas Supply Module APGAR Timer When the APGAR Timer is activated the APGAR Timer display shows e...

Страница 27: ...ed to the controller the Probe indicator flashes and a ramping alarm sounds Additionally the word Lo displays in the baby temperature display due to the baby skin probe reading 18 C ambient temperature After correcting the cause of the alarm the alarm automatically resets Baby Temperature When the temperature sensed by the skin probe is 1 C above or below the Set Temperature display setting in Bab...

Страница 28: ...nder continues to supply whichever gas has the higher pressure either 100 air or 100 oxygen This alarm is an acoustic alarm signal only there are no visual indicators If a blender is present both sources of air and oxygen must be connected turned on and present to prevent the Differential Bypass alarm from activating NOTE Because this alarm is pneumatically powered either O2 or air must be present...

Страница 29: ...PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 2 13 Features of the Resuscitaire Birthing Room Warmer WBR82 NOTE Suction bottle not shown It is on the lower right side of the warmer column ...

Страница 30: ...suscitaire 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 ...

Страница 31: ...he lower left side of the warmer column Warmer head Examination light Controller Blender Suction Resuscitation module Gas supply module Bassinet mattress and panels X ray tray Pass thru drawer Cylinder mounting bracket Vari Tilt mechanism Handle Steering Castor Height adjustment foot pedals Instrument tray Castor Castor lock Steering lock ...

Страница 32: ...rough drawer It also includes two 38 mm accessory poles and two instrument trays one for each side of the bassinet RW82 only Warmer Module The warmer module houses a heating element and an examination light for special procedures Controller The controller provides pre warm manual heat control and automatic skin temperature servo control It also contains an APGAR Timer skin temperature display heat...

Страница 33: ...esuscitation Modules have an adjustable airway pressure relief Precision blender standard in the US with Autobreath Resuscitation Modules Oxygen pipeline and cylinder gas supply module included on all variants Oxygen Air pipeline and cylinder gas supply module included on blender variants only Anti static castors WBR82 only CAUTION Castors do not control all the Electro Static Discharge ESD charac...

Страница 34: ...e of 10 Micro volume suction bottle package of 10 Reusable suction bottle 600 mL RW82 only Disposable suction bottle 800 mL each filter included in lid WBR82 only Filter for reusable suction bottle package of 25 Reusable probes skin probe Disposable breathing circuit 15 mm without exhalation valve for use with breathing bag pack age of 25 Disposable breathing circuit 15 mm with exhalation valve pa...

Страница 35: ...Display Range 0 00 to 59 59 min sec APGAR Timer Display Accuracy 0 1 s APGAR Timer Display Resolution 1 s MANUAL HEAT CONTROL Adjustable in 10 increments from zero to full power 100 Heater Element Life Expectancy 1000 hours of operation IRRADIANCE Pre Warm Mode 30 Heater Power Radiant Energy Output 10 mW cm2 maximum 60 Heater Power Radiant Energy Output 30 mW cm2 maximum 100 Heater Power Radiant E...

Страница 36: ...oles 2 each RW82 only 38 mm diameter x 600 mm Accessory Pole Weight Limit 6 kg 13 2 lb each or combined weight of 12 kg 26 5 lb Instrument Tray Dimensions 33 0 cm 13 x 22 8 cm x 9 0 Instrument Tray Weight Limit 2 2 kg 5 lb CYLINDERS NOTE To determine proper cylinder length fully lower the VHA and measure from the center line of the gas inlet to the floor Cylinder Diameter 10 cm 4 minimum 12 cm 5 m...

Страница 37: ...ge 5 RH to 95 RH non condensing Storage Transport Altitude Range up to12 km up to 40000 ACOUSTICS Measuring device located 3 m 9 8 in front of device and 1 5 m 70 9 above device Acoustical Level no alarms on 60 dBa maximum Acoustical Level all alarms on 75 dBa maximum Acoustical Level measuring device on the mattress 80 dBa maximum DEVICE CLASSIFICATION Protection Class IEC60601 1 Class I type BF ...

Страница 38: ...th Infant Resuscitator Feature factory installed option I E Ratio Fixed internally at 1 2 nominal non adjustable Adjustable PEEP at 10 LPM Minimum PEEP 0 4 kPa 4 cmΗ2Ο at 15 LPM Maximum PEEP 1 4 kPa 14 cmH2O Adjustable Respiratory Rate Range 18 BPM to 60 BPM 10 of setting Adjustable Airway Pressure Relief range of working pressure 0 cmH2O 0 kPa to 50 cmH2O 4 9 kPa 5 cmH2O 0 5 kPa Fixed Maximum Pre...

Страница 39: ...ubing 6 mm 0 25 inner diameter by 1 5 m 5 with sure grip female molded connector Total Flow Resistance without attachments subassemblies or components added to the breathing system 2 cmH2O 15 LPM Total Flow Resistance with attachments sub assemblies or components added to the breath ing system 6 cmH2O 5 LPM Blender Module Oxygen Concentration Adjustable 21 O2 100 O2 Feature Dimension ...

Страница 40: ...cm 12 0 X ray Tray Weight Limit 2 2 kg 4 5 lb maximum X ray Tray Dimensions 36 8 cm 14 5 x 27 9 cm 11 0 x 1 9 cm 0 75 I V Pole Weight Limit WBR82 only 2 2 kg 5 lb maximum Basket Assembly Weight Limit WBR82 only 2 2 kg 5 lb maximum Adjustable Utility Shelf Weight Limit RW82 only 3 kg 6 6 lb Drawer Dimensions inside RW82 only 31 5 cm 12 4 x 47 7 cm 18 78 x 19 cm 7 5 deep all dimensions have a tolera...

Страница 41: ...e 1 min 5 min and 10 min APGAR timer inter vals Power Fail Activates when there is a loss of power Stays activated for 10 min Probe Fail Activates if the skin probe fails open or short System Fail Indicates a system failure Refer the unit to service immediately Baby Temperature Activates if the baby temperature fluctuates 1 C above or below the setpoint Electrical Module Audio Ramping Alarms 80 dB...

Страница 42: ...t WEEE Annex IV EN794 1 1997 Lung ventilators Part 1 Particular requirements for critical care ventilators including Amendment 1 2000 NOTE Does not apply to the Resuscitaire Wall Mounted Radiant Warmer WMRW82 only because it is not equipped with resuscitation or suction equipment EN10079 3 1999 Medical suction equipment Part 3 Suction equip ment powered from a vacuum or pressure source NOTE Does n...

Страница 43: ...Environment Guidance Radio frequency RF emissions CISPR 11 Group 1 The Resuscitaire Radiant Warmers use RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause interference with nearby electronic equipment RF emissions CISPR 11 Class A The Resuscitaire Radiant Warmers are suitable for use in all establishments other than domestic and those direc...

Страница 44: ...this product Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycles 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95...

Страница 45: ...aration Distance Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz out side ISM bands 3 Vrms 10 Vrms 150 kHz to 80 MHz in ISM bands 10 Vrms Radiated RF IEC 61000 4 3 10 V m 10 V m 26 MHz to 800 MHz 26 MHz to 2 5 GHz 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in ...

Страница 46: ...3 8 m 7 3 m 100 W 12 m 12 m 12 m 23 m For transmitters rated at a maximum output not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter man ufacturer NOTE At 80 MHz and 800 MHz the higher frequency rang...

Страница 47: ...condary reflector directly under the warmer heater element for particles If particles are present replace the heater element Failure to do so could result in patient injury or equipment damage WARNING Do not use the bassinet ends or the side panels to push or pull the Resuscitaire Radiant Warmer Patient injury personal injury or equipment damage could occur WARNING When the front and side panels a...

Страница 48: ... warmer Remove anything such as blankets clothing or equipment that interfere with the radiation from the warmer from between the radiant warmer and the infant Failure to do so could result in patient injury or equipment damage WARNING Sunlight and some accessories such as phototherapy or heated mattresses can increase patient temperature to dangerous levels Monitor the temperature of the patient ...

Страница 49: ...ment damage could occur WARNING Do not remove the back cover a high pressure source is inside Refer servicing to qualified personnel Personal injury or equipment damage could occur WARNING The heater assembly may be hot enough to cause burns Before cleaning or touching the warmer head allow 30 min for the unit to cool sufficiently after removing power from the unit Failure to do so could result in...

Страница 50: ...ust service the unit Failure to do so could result in patient injury personal injury or equipment damage SHOCK HAZARD Plug the power cable only into a properly grounded wall receptacle approved for hospital use and of the correct voltage Do not use extension cords or an AC receptacle box for this device Personal injury or equipment damage could occur SHOCK HAZARD Use only the power cables supplied...

Страница 51: ...tions Measure oxygen concentrations with a calibrated oxygen analyzer at intervals directed by the attending physician Failure to do so could result in patient injury WARNING Keep matches lit cigarettes and all other sources of ignition out of the room in which the equipment is located Textiles oil and other combustibles are easily ignited and burn with great intensity in air enriched with oxygen ...

Страница 52: ...to its maximum height and install remove the cylinder Failure to do so could result in personal injury or equipment damage WARNING Ensure that oxygen cylinders are securely mounted and connected before use Failure to do so could result in equipment damage or personal injury WARNING Maintain Patient Outlet 2 gas pressure at or below 15 7 kPa 160 1 cmH2O The Patient Outlet 2 gas has a separate press...

Страница 53: ...ft If knobs come loose qualified service personnel must calibrate the unit Failure to do so could result in patient injury or equipment damage Resuscitation Precautions Common to All Modules WARNING Only qualified clinical personnel must use the optional resuscitation module Before using the equipment read the instructions Failure to do so could result in patient injury WARNING Always operate the ...

Страница 54: ... fittings Failure to do so could result in patient injury or equipment damage WARNING Require wall gas supplies at 276 kPa 40 psi to 517 kPa 75 psi Failure to operate at this range could result in patient injury or equipment damage WARNING Do not place flow restrictions in the supply line Patient injury or equipment damage could occur WARNING If a compressor is used as the air source take steps to...

Страница 55: ...t injury WARNING Periodically measure blood gases to ensure proper levels of ventilation Failure to do so could result in personal injury WARNING Before use confirm that the oxygen air blender control of the blended gas supply module is correctly set Failure to do so could result in patient injury WARNING Ensure that the breathing circuit connections are secure and free of obstructions Failure to ...

Страница 56: ...tient injury WARNING For MU25180 MU25176 and MU25179 the Patient Outlet 2 does not provide adjustable pressure limiting If the blender option is installed it delivers blended gas Otherwise it delivers 100 oxygen Pressure is internally limited to 15 7 kPa 160 1 cmH2O Always use a patient resuscitation circuit that includes appropriate pressure release Failure to do so could result in personal injur...

Страница 57: ...inical personnel only These instructions must be read before using the equipment Failure to do so could result in patient injury or equipment damage WARNING When setting the PEEP control always start with the knob fully counterclockwise to avoid setting the PEEP above the maximum pressure limit Failure to do so could result in patient injury WARNING Do not leave the patient unattended when using t...

Страница 58: ... accordance with the EMC information provided on page 2 27 Portable and mobile RF communications equipment can affect medical electrical equipment WARNING This product has been validated with the accessories and options listed in this manual It is found to comply with all relevant safety and performance requirements applicable to the device It is therefore the responsibility of that person or orga...

Страница 59: ...y restrict the gas flow This restriction could cause the indication of the gas flow and the adjustable airway pressure relief to be inaccurate Patient injury could occur WARNING Inspect the infant skin for reddened areas which result from heating of materials such as plastic diapers or pins in contact with the skin or from removing a layer of skin when removing the probe cover Failure to do so cou...

Страница 60: ...for additional information Preventive maintenance or troubleshooting performed by unauthorized personnel could result in personal injury or equipment damage SHOCK HAZARD The potential for electrical shock exists with electrical equipment Establish policies and procedures to educate your staff on the risks associated with electrical equipment SHOCK HAZARD If the controller or other parts of the equ...

Страница 61: ...aged when installing a disposable suction bottle position the outlet port parallel to the plate Make sure that the tubing is not kinked CAUTION When using AC power secure the line cord to the back cover to prevent it being removed from the controller chassis Failure to do so could result in equipment damage CAUTION Do not use harsh cleansers detergents such as scouring pads and heavy duty grease r...

Страница 62: ...metal surfaces with products containing bleach type cleaners which are corrosive to metal surfaces Failure to do so could result in equipment damage 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 CAUTION Do not overload the optional shelf WBR82 only The maximum weig...

Страница 63: ...ories ordered The Resuscitaire Radiant Warmer RW82 is shipped in one carton that contains the following assemblies Bassinet Cart Upper post Warmer module assembly User installed accessories The Resuscitaire Wall Mounted Radiant Warmer WMRW82 is shipped in one carton that contains the following assemblies Modified post assembly Warmer module assembly CAUTION When removing the equipment from the car...

Страница 64: ...s of sufficient strength to lift the upper post Failure to do so could result in personal injury or equipment damage 4 Using two persons of sufficient strength lift the upper post D and rest it on top of the opening of the base weldment E 5 Fully extend the suction hoses F from the upper post and the base weldment and then connect them to each other 6 Carefully feed excess hose into the upper post...

Страница 65: ...port plate C 14 Tighten the two 10 32 x 3 8 Nylok screws H installed in step 11 to secure the warmer I to the upper post D 15 Remove and discard the two 10 32 x 3 8 Nylok screws K from the lower corners of the head support plate 16 Thread the power cable L out through the opening in the front of the upper post 17 At the controller B connect the power cable to connector J4 on the power and control ...

Страница 66: ...e two 10 lockwashers the rear handle T and the two spacers to secure the rear handle to the lower rear cover 24 Connect the line cord to the power connector U on the rear of the controller CAUTION To prevent removal of the controller chassis with the AC power switched on secure the line cord to the back cover Failure to do so could result in equipment damage 25 Install the 8 32 x 3 8 screw and the...

Страница 67: ...orm the Operational Checkout Procedure on page 4 15 Cart and Bassinet 1 Install the rear and side panels on the bassinet 2 Raise the front panel from its storage slot and lock it in place 3 Engage the cart and bassinet to the warmer a Push the cart and bassinet straight onto the warmer until it latches b Pull on the cart and bassinet to ensure that it is latched properly 4 To disengage the cart an...

Страница 68: ...ler B to the head support plate C Retain the two 8 32 x screws 2 Slide the controller B out through the front of the upper post D WARNING Use two persons of sufficient strength to lift the upper post Failure to do so could result in personal injury or equipment damage 3 Using two persons of sufficient strength lift the upper post D and rest it on top of the opening in the column E of the bassinet ...

Страница 69: ...t malfunction could occur 5 Feed the suction hose G from the upper post through the hole at the bottom H so that it is available for the suction bottle when installed 6 Install the two 10 32 x 3 4 screws and lock washers I provided through the bottom of the base of the column 7 Install the four 10 32 x 3 8 Nylok screws J provided to secure the upper post to the bassinet cart assembly D E G G H I I...

Страница 70: ...port plate C 11 Tighten the two 10 32 x 3 8 Nylok screws K installed in step 7 to secure the warmer to the upper post 12 Remove and discard the two 10 32 x 3 8 Nylok screws P from the lower corners of the head support plate 13 Thread the power cable Q out through the opening in the front of the upper post 14 At the controller connect the power cable Q to connector J4 on the power and control P C b...

Страница 71: ...hed on secure the line cord to the back cover Failure to do so could result in equipment damage 20 Install the power cables a Connect the line cord to the power connector W on the lower rear of the bassinet cart assembly F b Connect the power cable between the power receptacle X on the center rear of the bassinet cart assembly F and the power connector Y on the controller c Using the cable clamps ...

Страница 72: ...into their slots on the bassinet 24 Install the 38 mm poles a Set the 38 mm pole EE into the circular opening on the bassinet cart assembly b Install the short hex head screw FF through the bottom of the bassinet cart assembly and into the 38 mm pole c Install the long hex head screw GG through the 38 mm pole EE and the spacer HH into the side of the upper post d Repeat to install the other 38 mm ...

Страница 73: ...e or personal or patient injury NOTE Due to space constraints the Resuscitaire Wall Mounted Radiant Warmer must be fully assembled except the wall mount cover plate before it is mounted on the wall 1 Remove the back cover A from the modified post B by removing the two screws C 2 Remove the controller D by removing the four screws E 3 Mount the modified post B on the wall mount bracket F using the ...

Страница 74: ...oles on the inside of the modified post 6 Install the four 10 32 x 3 8 Nylok screws M to secure the pivot bracket N to the head support plate O 7 Tighten the two 10 32 x 3 8 Nylok screws J installed in step 4 to secure the warmer to the modified post 8 Remove and discard the two 10 32 x 3 8 Nylok screws M from the lower corners of the head support plate 9 Thread the warmer power cable P out throug...

Страница 75: ...ull out force specification Failure to do so can result in an unsafe installation that could cause equipment damage or personal or patient injury WARNING Consult a structural design professional to determine the specific construction and installation details to meet the installation specifications Failure to do so can result in an unsafe installation that could cause equipment damage or personal o...

Страница 76: ...eded when tilted at 10 WARNING Observe the maximum load of 38 mm poles and accessories attached to 38 mm poles Danger of overturning the unit if poles or accessories are overloaded Patient injury could occur Maximum load of each pole 38 mm 6 kg 13 2 lbs Maximum load of both poles combined 12 kg 26 5 lbs NOTE Any equipment mounted on the accessories must not collide with the unit when adjusting the...

Страница 77: ...ent injury personal injury or equipment damage 1 Plug the AC line cord into the power connector on the rear panel SHOCK HAZARD Plug the power cable only into a properly grounded wall receptacle approved for hospital use and of the correct voltage Do not use extension cords or an AC receptacle box for this device Personal injury or equipment damage could occur 2 Plug the power cable into an appropr...

Страница 78: ...ower indicators go off An alarm sounds continuously and ramps up in volume k Press the Silence Reset key The Chk Patient indicator and the alarm go off and the heater comes back on along with the Heater Power indicators 7 Check the Keypad Lock key a Press the Keypad Lock key The Keypad Lock key lights and the Mode Select key and the Up and Down arrow keys are inoperable b Press the Keypad Lock key...

Страница 79: ...s the Examination Light key The examination light goes off 13 Check the Power Failure alarm NOTE The unit must be connected to the AC line for at least 8 min before the power failure circuitry becomes active a Switch off the circuit breaker on the rear panel b Switch on the On Off switch on the front panel c The Power Fail indicator comes on and the alarm sounds d Switch off the On Off switch and ...

Страница 80: ...om 0 to 10 c Return the bassinet to the level position 3 Check the bassinet side panels Resuscitaire Birthing Room Warmer shown a Raise each side panel and pivot it to hang straight down b Return each side panel to its original position c Check that each side panel is positively engaged to confine the infant 4 Check the bassinet front panel a Raise the front panel and slide it under the mattress b...

Страница 81: ... touch under the warmer module Personal injury could occur a Push the sides of the warmer module and rotate it 90 to the left or right of center Do not touch under the warmer module WARNING For effective heating ensure that the warmer module is centered above the patient Failure to do so could result in personal injury b Return the warmer module to its center position 7 Check the operation of the ...

Страница 82: ...ssinet Resuscitaire Radiant Warmer only WARNING For optimum stability always lower the Variable Height Resuscitaire Radiant Warmer to its lowest position before transport If installed ensure that items placed on the shelves are properly secured Failure to do so could result in patient injury personal injury or equipment damage 11 Check the Variable Height VHA stand Resuscitaire Radiant Warmer only...

Страница 83: ...m the source with the highest pressure Check cylinder gauges to determine gas source Blended Gas Supply Optional WARNING If either the air or oxygen gas source pressure is reduced creating a pressure differential of 207 kPa 30 psi the microblender alarm sounds This condition can alter the FiO2 and flow output from the microblender Patient injury could occur WARNING Always operate the system with m...

Страница 84: ... the suction bottle outlet port Then secure the free end of the extension tubing in either tubing retaining slot provided on the front and rear panels of the bassinet 4 Switch on the Suction On Off switch An initial reading of up to 30 mmHg 16 cmH2O appears on the suction gauge This reading is due to flow resistance of the hydrophobic filter and the suction tubing NOTE The filter and tubing resist...

Страница 85: ...it is necessary to administer oxygen notify the attending physician immediately Failure to do so could result in patient injury 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 alway...

Страница 86: ...epth of the compression affect the flow rate through the valve When the adjustable airway pressure relief valve is set under a constant flow condition and the breathing bag is squeezed the peak airway pressure may exceed that setting To ensure that the peak inspiratory pressure is set under more realistic conditions before use on an infant adjust the airway pressure relief while simulating normal ...

Страница 87: ...ly Failure to do so could result in patient injury 1 Before use ensure that all sources of gas are switched off 2 Before patient use switch OFF the AutoBreath Infant Resuscitator using the On Off switch on the module 3 Connect the Automatic Patient Circuit to the Patient Outlet connector 4 Connect the exhalation valve control line tubing to the Exh Valve connector 5 Switch on the gas supply at the...

Страница 88: ...ounds This condition can alter the FiO2 and flow output from the microblender Patient injury could occur WARNING Always operate the low flow microblender with medical grade gases Failure to do so could result in personal injury 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 ...

Страница 89: ...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 If the skin probe is disconnected from the controller the display is blank in Manual and Baby Mode When in Pre Warm Mode for software versions 1 08 or greater the dis play indicates PrE regardless of whether the probe i...

Страница 90: ... arrow key to lower the set temperature from 37 0 C 98 6 F to 34 0 C 93 2 F Press once to lower the set temperature in 0 1 increments Press and hold to lower the set temperature rapidly In Temperature Override Mode press the Up arrow key to raise the set temperature from 37 0 C 98 6 F to 38 0 C 100 4 F Press the Down arrow key to lower the set temperature from 38 0 C 100 4 F to 37 0 C 98 6 F When ...

Страница 91: ...he Silence Reset key within 5 min If at the end of 5 min 15 min total the Silence Reset key has not been pressed the heater shuts down and a three level alarm sounds continuously System Fail alarm indicator When an internal malfunction or operator error is detected the indicator illuminates and the alarm sounds continuously In addi tion an error code such as Er01 to Er023 appears in the Baby Tempe...

Страница 92: ... is operating in Baby Mode Mode Select key Press to select Pre Warm Manual or Baby Mode of operation NOTE Defaults to Pre Warm upon power up Skin probe connector Accepts the skin probe for monitoring the infant skin temperature When connected the Baby Temperature display indicates the temperature sensed by the probe when in Manual or Baby Modes When in Pre Warm Mode for software version 1 08 or gr...

Страница 93: ...en 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 Name Description Power inlet Accepts the AC power cable On Off switch Switches the device on and off Fuse Turns the actuator RW82 VHA only off when the presence of excessive current is detected Press to reset the actuator ...

Страница 94: ...r Controls for the VHA Stand RW82 Name Description Power outlet Outlet is used to connect the AC power cable from the lower post to the controller 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 A ...

Страница 95: ...ygen control Blends the air and oxygen mixture from 21 to 100 oxygen to the primary patient outlet Name Description Air cylinder gauge Provides an indication of the Air cylinder supply pressure from 0 kPa 0 psi to 27 579 kPa 4000 psi Oxygen cylinder gauge Provides an indication of the oxygen cylinder supply pressure from 0 kPa 0 psi to 27 579 kPa 4000 psi Gas supply On Off switch Activates the gas...

Страница 96: ...is installed it delivers blended gas Otherwise it delivers 100 oxygen Flow Rate LPM control Adjusts the patient gas flow from 0 LPM to 15 LPM Airway Pressure port if equipped Provides a connection for the airway pressure gauge to the breath ing circuit Airway Pressure gauge only works with Primary Flow Displays the airway pressure from 1 kPa 10 cmH2O to 8 kPa 80 cmH2O Patient Outlet 2 Connection f...

Страница 97: ...sts breath frequency from 18 to 60 breaths per minute PEEP control AutoBreath Infant Resuscitator Option Adjusts positive end expiratory pressure On Off switch AutoBreath Infant Resuscitator Option Turns AutoBreath Infant Resuscitator on and off including PEEP Exhalation valve AutoBreath Infant Resuscitator Option Accepts exhaust valve line of patient circuit for expiratory valve control Airway Pr...

Страница 98: ...pressure port Connects the airway pressure gauge to the patient breathing circuit Patient Outlet 2 Connection for the gas delivery line at the hose barb connection on the front panel If the blender option is installed it delivers blended gas Otherwise it delivers 100 oxygen Use tubing with an inner diameter of 0 25 0 64 cm Flow Rate 2 LPM control Adjusts the patient gas flow from 0 LPM to 15 LPM f...

Страница 99: ...re are potential hazards associated with the delivery of supplemental oxygen If it is necessary to administer oxygen notify the attending physician immediately Failure to do so could result in patient injury WARNING Always monitor the airway pressure and set appropriate pressure relief during infant resuscitation Failure to do so could result in patient injury WARNING For prolonged resuscitation u...

Страница 100: ...on the front panel 4 Observe the functional test Pre Warm Mode NOTE During Pre Warm Mode the alarms are deactivated NOTE Selecting Manual or Baby Mode and then returning to Pre Warm Mode during the 3 min of 100 power or the 12 min of 60 power automatically reduces the power to 30 NOTE The patient end of the skin probe must be attached or a probe alarm occurs This alarm indicates a difference of 0 ...

Страница 101: ...from removing a layer of skin when removing the probe cover Failure to do so could result in patient injury WARNING A change in the heater power output does not result in an immediate change in the infant temperature Large changes in the heater power output cause a more rapid change in the infant temperature Wait for results Failure to do so could result in personal injury 5 Check the infant tempe...

Страница 102: ... the hazards of overheating or underheating do not leave the infant unattended WARNING Only properly trained personnel directed by an appropriately qualified physician aware of the currently known hazards and benefits must use infant radiant warmers Otherwise personal injury could occur WARNING Inspect the infant skin for reddened areas which may result from heating of materials such as plastic di...

Страница 103: ... of the infant skin temperature Failure to maintain direct skin contact could result in overheating and possible burning WARNING Check the infant condition at least every 15 min for correct sensor attachment and for signs of overheating Failure to do so could result in personal injury WARNING To prevent false temperature indications place the skin probe at least 3 8 cm 1 from any transcutaneous mo...

Страница 104: ...ant or the skin probe not being in direct contact with the skin 5 Verify that the Baby Temperature display reading stabilizes within 0 2 C of the Set Temperature display 6 To silence any Baby Temperature alarms for 10 min press the Silence Reset key NOTE If nursing personnel are in constant attendance and a Probe alarm occurs use Manual Mode temporarily if the skin probe must be disconnected until...

Страница 105: ...ise a front panel pull it out from under the mattress rotate it until it is vertical and let it lower into place Back Panel You can either remove the back panel or pivot it slightly 1 To remove the back panel raise it straight up and out of the corner bracket 2 To replace it securely hold it vertically slide the lower pins into the opening half way down the corner bracket and let it drop into plac...

Страница 106: ...ge from 0 to 10 Trendelenburg 2 Rotate the Vari tilt knob in the front of the bassinet counter clockwise through the entire range from 0 to 10 reverse Trendelenburg Docking and Undocking Resuscitaire Birthing Room Warmer WBR82 only WARNING For patient safety and effective heating properly dock and latch the cart to ensure correct bassinet positioning 1 To dock the cart and bassinet to the warmer p...

Страница 107: ... left or right bassinet side panel up c Slide the x ray tray out d Place the x ray cassette on the tray e Return the x ray tray to the bassinet f Align the x ray tray as desired with the markings on the x ray cassette and the relative markings on the inside of the bassinet walls 2 When the x ray is complete perform the following a Remove the x ray cassette b Return the x ray tray c Place the warme...

Страница 108: ...of the warmer and an outer bracket that mates with the cylinder There is also a strap to secure the cylinder to the outer bracket 1 Once the cylinder is properly installed on the RW82 wrap the cylinder strap A around the cylinder 2 Close the latch B 3 Pull on the strap until it is secure 1 Once the cylinder is properly installed on the WBR82 slide the outer bracket A away from the lower post until...

Страница 109: ...o excessive moisture Personal injury or equipment damage could occur CAUTION Do not use harsh cleansers solvents or detergents Equipment damage could occur WARNING Cylinder heights vary When replacing a gas cylinder ensure that the cylinder does not exceed the maximum cylinder height specification Also before placing the cylinder confirm that there is sufficient clearance between the bottom of the...

Страница 110: ...fectant such as CaviCide Surface Disinfectant Decontaminant Cleaner or equivalent registered by the U S Environmental Protection Agency Disinfect only when the equipment is not in use and disassembled see Disassembly for Cleaning on page 6 5 When using any cleaning agent follow the manufacturer directions for use Clean and disinfect the device using disinfectants and protocols approved by your hos...

Страница 111: ...tly after removing power from the unit Failure to do so could result in personal injury CAUTION Avoid cleaning metal surfaces with products containing bleach type cleaners which are corrosive to metal surfaces Failure to do so could result in equipment damage Use an EPA registered disinfectant detergent such as cold sterilants and quarternary ammonium compound disinfectants to clean all surfaces t...

Страница 112: ...ace the filter and tubing after each patient use Cold or Gas Ethylene Oxide Sterilization 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 Before gas sterilization the entire unit must be thoroughly cleaned as described in the cleaning topics of this section Remov...

Страница 113: ...t 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 b Remove the bassinet back panel from the unit 3 Remove the bassinet front panel a Raise the bassinet front panel and then swivel it down b At the corners press up on the release buttons Release button ...

Страница 114: ...emove 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 NOTE For cleaning instructions for the SoftBed mattress refer to the Instructions for Use that accompanies the SoftBed mattress ...

Страница 115: ...aight down into their slots 5 Return the bassinet front panel to the unit a Slide the bassinet front panel into the front of the bassinet until the release tabs catch b Raise the bassinet front panel into position 6 If a reusable suction bottle is in use install a new suction filter 7 If a disposable suction bottle is in use replace it 8 After cleaning and assembly perform a complete operational c...

Страница 116: ...orized personnel could result in personal injury or equipment damage Only facility authorized service personnel must perform preventive maintenance on the Resuscitaire Radiant Warmer products WARNING Risk of patient injury or equipment damage Loose particles from the heater element could cause patient injury or equipment damage During maintenance inspect the secondary reflector directly under the ...

Страница 117: ...ears Every Six Years Personnel Responsible Replaceable parts Mattress X Users and service personnel Skin probes X X Users and service personnel Probe covers X X Users and service personnel Suction bottle X X Users and service personnel Maintenance Device servicing and main tenance X Service personnel Replace Oxygen hose wall or cylinder to Resuscitaire X X Users and service personnel Replace Air h...

Страница 118: ...PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 6 10 Pneumatic System Pneumatic System Block Diagram ...

Страница 119: ... and instructions MU10923 Replacement filters and tubing for reusable suction bottle box of 25 MU10915 Replacement filters 40 cc micro volume suction bottle box of 10 MU10917 Replacement filter 40 cc micro volume suction bottle 1 each MU09577 Mattress assembly 20 50 x 25 75 MP01402 SoftBed mattress MU11225 Probe 3 skin temperature reusable MU11228 Probe 3 skin temperature dual disposable box of 10...

Страница 120: ...r Medical organization Alternatively further information can be obtained from our national Draeger Medical organization All potential biohazards used with this device must be disposed of per local requirements Safe disposal of the Resuscitaire Radiant Warmer at the end of its lifecycle must be conducted per local requirements MU11873 I V pole WBR82 only MU10637 I V pole adapter WBR82 only MU21277 ...

Страница 121: ...arm activates The circuit breaker on the con troller is tripped Reset the circuit breaker The power cable is unplugged Plug the power cable into the POWER connector on power input The power cable is damaged Replace the power cable The System Fail alarm activates An error code appears There is an internal malfunction Refer the unit to service The System Fail alarm activates No error code appears Th...

Страница 122: ...ng hose is bent or tan gled Replace the hose Hose is leaking between the reg ulator and the bottle Replace the hose Pressure or suction gauge is not measuring correctly Refer the unit to service Blender O2 concentration setting does not match the blender set ting Blender knob is loose Refer the unit to service Do not attempt to tighten the knob as this voids unit calibration Blender has failed Rep...

Страница 123: ...FT 5 Feb 04 7 3 The Inspiratory Expiratory I E Ratio is Greater Than 1 2 4 and Less Than 1 6 1 1 1 Resuscitation Module has failed Replace the resuscitation mod ule or refer the unit to service Symptom Possible Cause Corrective Action ...

Страница 124: ...PROPRIETARY AND CONFIDENTIAL DRAFT 5 Feb 04 7 4 This page intentionally left blank ...

Страница 125: ...This page intentionally left blank ...

Страница 126: ... Medical Systems Inc 3135 Quarry Road Telford PA 18969 U S A 215 721 5400 800 4DRAGER 800 437 2437 FAX 215 723 5935 http www draeger com Distributed in US by Draeger Medical Inc 3135 Quarry Road Telford PA 18969 U S A 215 721 5400 800 4DRAGER 800 437 2437 FAX 215 723 5935 http www draeger com In Europe Canada Middle East Africa Latin America Asia Pacific distributed by Dräger Medical GmbH Moisling...

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