BEAR CUB™750 vs INFANT VENTILATOR MAINTENANCE MANUAL 50000-12178 Ee, Bear Medical Systems, Ine, 1100 id Cerca Divo Pai Springs, CA 2262 USA Phone (70) 7781200 (00 S57 380 ax ONTITIT Copyright © 1997 ; 2119 Allied Healtheare Products, Inc. Serial #PREFACE PROPRIETARY INFORMATION INFORMATION CONTAINED WITHIN THIS MAINTENANCE MANUAL IS PROPRIETARY TO ALLIED HEALTHCARE PRODUCTS, INC., AND MAY BE USED ONLY FOR THE PURPOSE OF PROVIDING MAINTENANCE. THE PURCHASE, RECEIPT OR POSSESSION OF THIS MAINTENANCE MANUAL DOES NOT CONFER, TRANSFER, OR LICENSE ANY OTHER RIGHTS IN THIS INFORMATION. ANY OTHER USE OR DISCLOSURE AND/OR REPRODUCTION (by any method) OF THE INFORMATION CONTAINED HEREIN 1S PROHIBITED UNLESS EXPRESSLY PERMITTED HEREIN. INTRODUCTION ‘The BEAR CUB™ 750vs Infant Ventilator Maintenance Manual contains electrical and mechanical verification, calibration, troubleshooting and replacement instructions prepared to assist a qualified biomedical technician in the maintenance of the ventilator. ‘The Maintenance Manual is specifically intended for use by an authorized service person. Any adjustments or procediures that exceed the scope of this manual should be referred to a Bear Medical Systems Factory Service Center. For specific operating instructions and clinical theory of operation, refer to the BEAR CUB™ 750vs Infant Ventilator Instruction Manual (51-10641-00). Maintenance personnel should become thoroughly familiar with the Operating and Repair techniques before servicing this equipment. Page Numbering — The page numbering system used. throughout this manual is as follows: = June 1996 ‘The month/year indicates the revision level of the individual page. When a page(s) has been revised, the month and year will be updated. Where no change has occurred, the month and year will remain unchanged even though the page may have been reprinted in the revision process. 50000-12178 This indicates the part number of the base manual or component section. NOTE Sections 3 and 9 have different part numbers, as they were prepared as individual documents. They do interrelate to the base maintenance manual. ALLIED HEAITHCARE PRODUCTS, INC STANDARD WARRANTY ‘Allied Healthcare Proiducts, Inc. standard warranty is extended to the original buyer purchasing the equiprfent directly from Allied Healthcare Products, Inc, or through its authorized dealers, All warranty periods, where applicable, commence on the date of first purchase but not more than six months after shipment from Allied Healtheare Products, Inc, Allied Healthcare Products’ sole obligation and liability under this warranty is limited to (at Allied Healthcare Products option) the repair or replacement by Allied Healthcare Products authorized personnel of any parts or assemblies which, upon test and examination by Allied Healthcare Products prove to be defective. This equipment may be returned prepaid to Allied Healthcare Products after prior notification has been given and approval obtained for the return. ‘This warranty does not cover normal maintenance such as cleaning, adjustment, or lubrication and updating of ‘equipment or parts thereof. This warranty shall be void and not apply if the equipment, including any of its paris, is modified without Allied Healthcare Products’ authorization; is attempted to be repaired by personnel not authorized by Allied Healthcare Products; is not ‘maintained in accordance with the prescribed schedul is used with accessories or parts not authorized; or is damaged due to misuse, mishandling, abuse, negligence, accident, fire, or inadequate packaging by ‘owner for shipment. Allied Healthcare Products makes zo guarantee of clinical results. ‘THE WARRANTY STATED ABOVE (INCLUDING ITS LIMITATIONS) IS THE ONLY WARRANTY MADE BY ALLIED HEALTHCARE PRODUCTS AND IS IN LIEU OF ALL OTHER WARRANTIES, WHETHER EXPRESSED OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. ALLIED HEALTHCARE PRODUCTS SHALL NOT BE LIABLE FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES OF ANY KIND. Warranty period is one year with the following exceptions: Preventive maintenance (9U day) warranty on all parts and labor is included in all procedures. Page I + OCTOBER 1997 "50000-12178WARNING. Do not release this medical device if any alarmlalert function is inoperative. To do so could result in a malfunetion without waming, possibly resulting in personal injury up to including, death or property damage. Refer the unit to a Allied Healthcare Products Authorized Service ‘Technician or an Allied Healthcare Products Trained Hospital Service Technician. When a GAS SUPPLY FAILURE alarm occurs, the Blender will use the remaining gas supply. ‘This means that the oxygen concentration delivered to the patient may differ from the linician-selected 02 setting. CAUTION If any procedures cannot be verified as outlined in this document, disconnect the ventilator and refer it to Allied Healticare, or an Alliod Healthcare Authorized Service Facility, or an Allied Healtitcare Trained Hospital Service Technician. Do not sterilize the ventilator. The internal materials are not compatible with sterilization techniques. Do not use Methyl Ethy! Ketone (MEK) or Trichlovoetinylene, as damage to surface may result. Do not allow ‘any liquid to spill or drip into the ventilator. Circuit boards are subject to damage by static electricity. Do not touch components, circuit, or connector {fingers with hands. Hane ony by edges. Before using any test equipment (electronic or prieumatc) for ealitration procedures (other than Operational Verification), the accuracy ofthe instruments must be cerlfied by a testing laboratory, ‘The laboratory master test instruments must be lracenble to the U.S. Bureau of Standards or Equivalent. When riances exist Detween the indicated and actual values, the calibration curves (provided foreach instrument by the testing Inboratory) must be used to establish the actual correct oalues. This certification should be performed at lenst ‘once every six months. More frequent certification muy be required based on usage and environment Page Mil + OCTOBER 1997 SUUAEIZISection! BEAR CUB™ 750vs Infant Ventilator Specifications Controls .. Alarms. Monitors.. Preset Values.. Tolerances.. Emissions/Susceptibility Outputs... Inputs . Physical Dimension and Shipping Information... Environmental Specifications. Cleaning of External Surfaces Sterilization .... 60000-12178 + OCTOBER 1997SPECIFICATIONS EE eee | The BEAR CUB™ 750vs Infant Ventilator Performance Characteristics and Specificatians Controls Inspiratory Time Modes Range: (0.10t030seconds “NIC Resolution: 0.01 from 0.10 to 0.50 seconds In the Assist/Control position, a mechanical 0.02 from 0.50 to 1.70 seconds breath is delivered with each inepiratary effort, 0.05 from 1.70 to 3.00 seconds provided the patient satisfies the assist sensitivity ‘Accuracy: £0.02 seconds from 0.19 to 0.50 Criteria. I the patient does not meet the assist eae Sensitivity criteria, the ventilator astomatically- Spe esas aes geo caol Gelivers breaths accozding to the Ventilator Rate cae control. Mechanical breaths may then be either patient initiated (assisted) or ventilator initiated Inspiratory Flow (controle). Range: 140 30LPM + SIMV/IMV Resolution: 0.5LPM from 1 to 10LPM In the SIMV/IMV position, a combination of Nite ton wtssoLPd mechanical and spontaneous breath types is available. Mechanical breaths, either assisted or controlled, are delivered at the set ventilator rate Accuracy: Pressures to 60 cinHgO: +05 LPM or #: 10% of setting, whichev- while all other breaths are spontaneous. fee Disabling the assist sensitivity mechanism. or Pressure 60 10 72 emHzO: +05 removing the flow senor from the ventilator, LPM or + 10%/- 15% of setting, will cause the equivalent of IMV mode of ventila~ whichever is greater tion to exist. : a Baseline Flow In the CPAP position, the Base Flow control Range: 1 t030LPM establishes the continuous flow available for Resolution: 0.5 LPM from 1 to 10 LPM spontaneous breathing. 1.0 LPM from 10 to 30 LPM + STANDBY Accuracy: Prossures 0 to 60 cmmHz0: +08 ‘The STANDBY position discontinues all electrical LPM or # 10% of setting, whichev- controls and functions with the exception of the cer is greater. charging system for the internal battery. Pressure 60 to 72 cmH,0: £05 NOTE LPM or + 10%/- 15% of setting. If the ventilator is connected to air and O2 Whichever is greater sources, blended gas will circulate while ventila~ Hie or is in the STANDRY position, making gas Volume Limit available from the Auxiliary Gas Outlet. The Range: 5 to 300 ML amount of gas flow circulating is determined by Resolution: 1ML from to $0 ML the Base Flow setting, 2ML from 50 to 150 ML hae 5 ML from 150 to 300 ML Range: 110 1508°M Accuracy: £2MLor# 10% of setting, whichever is greater Resolution: 1 from 1 to 100BPM 2 from 100 to 150 BPM PEEP Tolerance: Greater of 1 BPM or 0.02 seconds Range: (0 t0 30 cmH applied to the Breath Interval Resolution: 1amFO Repeatability: 1 emHIzO or + 5%, whichever is. greater “US. Potent No.5, 540,220 50000-12178 + OCTOBER 1997