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1. Replacement of the sensor should only be performed by a trained qualified individual Page 4 of 8 COVIDIEN 11c 15 HAMPSHIRE STREET 508 261 8000 T MANSFIELD MA 02048 URGENT FIELD SAFETY NOTICE Attachment Ill Oxygen Sensor Replacement for the PB840 Ventilators There are 2 configurations of the PBPB840 Ventilator that influence the method required to change the Oxygen Sensor One configuration has an access port located along the top right edge of the breath delivery unit BDU cabinet that allows for direct access to the oxygen sensor Please refer to the pictures below to identify which configuration s your facility may have PB840 Ventilator with O2 access port PB840 Ventilator without O2 sensor access port Instructions for accessing Oxygen Sensor for the PB840 Ventilator with O2 Access Port j_imstructions rene vice Manual Service Manual Locate the flexible oxygen sensor access cover on the top edge of the cabinet Firmly push the center of the lower flap of the access cover until the lower flap is dislodged from the cabinet Pinch the bottom and top flaps of the access cover firmly together and pull the access cover away from the cabinet to remove the oxygen sensor Page 5 of 8 COVIDIEN 11c 15 HAMPSHIRE STREET 508 261 8000 T MANSFIELD MA 02048 URGENT FIELD SAFETY NOTICE Instructions for accessing the Oxygen Sensor for the PB840 Ventilator without O2 sensor2. HAMPSHIRE STREET 508 261 8000 T MANSFIELD MA 02048 URGENT FIELD SAFETY NOTICE WHEN YOU SEE IT MEANS THIS MESSAGE HIGH PRIORITY ALARM Measured oxygen percentage more than 10 percentage points below setting for at least 30 seconds Auto reset when measured 02 is within 10 percentage points of setting The ventilator may have been calibrated at a high altitude then moved to a lower altitude O2 LOW NO DIAGNOSTIC CODE LOGGED HIGH PRIORITY ALARM Technical Alert Oxygen Sensor missing or reading out of range REPLACE O02 Alarm does not auto reset you must SENSOR press alarm reset key DIAGNOSTIC CODE 6022 COVIDIEN 11c 15 HAMPSHIRE STREET 508 261 8000 T r MANSFIELD MA 02048 DO THIS Replacement of the sensor should only be performed by a trained qualified individual Perform FlO2 calibration check Replace Pressure Solenoid PCB Replacement of the solenoid should only be performed by a trained qualified individual Check patient Check oxygen supply Verify than an oxygen sensor is installed Check remaining sensor life via service summary and replace sensor if required Replacement of the sensor should only be performed by a trained qualified individual Perform FlO2 calibration check Perform these calibrations O2 Pressure Calib than if applicable Reg Altitude Calib Replace Pressure Solenoid PCB Replacement of the solenoid should only be p
3. 4 installed or used in a Ventilator after this date O2 Sensor The nominal life of the O2 sensor is 1 For this date code format MM YY the Life year from date of manufacture Install by 08 14 means that the sensor must be installed in a Ventilator before August 2014 It has one year of operational life if installed before the date on the label Customer Ensure that maintenance logs for the ventilator contain information identifying when Maintenance the sensor needs to be replaced to ensure it is not used on a patient where the Information useful life may expire while in use Factors Sensor life depends on operating environment operation at higher temperature or affecting O2 high O2 levels can shorten the sensor life sensor Life Page 3 of 8 COVIDIEN 11c 15 HAMPSHIRE STREET 508 261 8000 T MANSFIELD MA 02048 URGENT FIELD SAFETY NOTICE Attachment Il Oxygen Sensor Maintenance and Alarms for PB840 Ventilator Puritan Bennett 800 Series Ventilator System Operator s and Technical Reference Manual Operator preventive maintenance procedures and frequency Pages OP 7 11 OP 7 12 PREVENTIVE MAINTENANCE PREVENTIVE MAINTANCE REFERENCE SCHEDULE PART MAINTENANCE SOURCE FREQUENCY Daily or as necessary Oxygen Sensor Press the 100 O2 CAL 2 MIN key Puritan Bennett 800 Series or INCREASE O2 2min key to calibrate the oxygen Ventilator System sensor Refer to Appendix D in this manual to tes
4. N 066009A 09 02 e For the Puritan Bennett 740 amp 760 ONLY Please add this new information to your current Operator s Manual and Service Manual e Please ensure all O2 Sensors in use or in inventory conform to the instructions in this notification Page 1 of 8 COVIDIEN 11c 15 HAMPSHIRE STREET 508 261 8000 T MANSFIELD MA 02048 URGENT FIELD SAFETY NOTICE e Should a sensor become non functional during use and cannot be recalibrated an external oxygen monitoring device may be required to monitor the supplied level of oxygen to the ventilator o A non functional O2 sensor does not affect the concentration of oxygen delivered to the ventilator nor control the flow of gases e f a sensor becomes non functional and facility protocol requires transfer of a patient to an alternate ventilator patient conditions must be evaluated to determine the best time for transfer to reduce risk to the patient e Ventilators are not intended to be a comprehensive monitoring device An alternative source of ventilation should always be available when using a critical care ventilator e Using the ventilator s selectable alarm volume range be sure to select an alarm volume level that can be discerned above background noise levels This notification is being issued with the knowledge of the add local Competent Authority Should you have any questions regarding this letter or need to report any issues with the Puritan Ben
5. URGENT FIELD SAFETY NOTICE E COVIDIEN DAY MONTH 2014 FSCA Reference Oxygen Sensor instructions for PBPB840 amp 700 Series Ventilators XX 13 Dear Covidien Customer Covidien is conducting a voluntary field safety notification with updated labeling to clarify the operational life of the oxygen sensor O2 sensor PN 4 072214 00 used in the Puritan Bennett PB840 ventilator system and PN G 061143 00 used in Puritan Bennett 740 amp 760 ventilator systems The ventilators oxygen sensor has a nominal life of one year from date of manufacture depending on the operating conditions Previously conflicting information may have been provided to PBPB840 customers concerning the operational life of the oxygen sensor in a labeling Addendum for the PBPB840 The PBPB840 Operator s Manual states the sensor has a nominal life of one year from the date of manufacture while a PBPB840 Addendum incorrectly stated to replace the sensor every two 2 years The 740 and 760 Operator s Manual and Service Manual also states 2 years To determine the correct expiration date of the oxygen sensor the expiration date label on the sensor package identifies when the sensor may no longer be used The enclosed labeling update Attachment I provides detailed information related to sensor life and usage with your PB840 or 740 760 ventilators The enclosed update supplements the information in the current Operator s Manual of your PB840 system and replaces informat
6. access port Reference PB840 Ventilator System Service Manual If your BDU unit does not have an access port on the top right edge of the housing use the following instructions to replace the oxygen sensor 1 Remove the inspiratory module 2 Disconnect oxygen sensor harness from the sensor Be sure to press the wire retainer tab inside the recess of the oxygen sensor to release the connector 3 Unscrew oxygen sensor from PSOL manifold Please refer to your Service Manual for detailed instructions related to oxygen sensor replacement Page 6 of 8 COVIDIEN 11c 15 HAMPSHIRE STREET 508 261 8000 T MANSFIELD MA 02048 URGENT FIELD SAFETY NOTICE Attachment IV Oxygen Sensor Maintenance and Alarms for PB700 Series Ventilators Specific information related to the O2 sensor maintenance and alarms for the PB700 Series ventilators is described below for reference Please refer to precautions and warnings in the operator s manuals for proper use of the ventilators 700 SERIES VENTILATOR OPERATORS MANUAL PREVENTIVE MAINTENANCE PREVENTIVE MAINTANCE SCHEDULE PART MAINTENANCE FREQUENCY Oxygen Sensor Perform a calibration by selecting Calibrate O2 Sensor from the MENU aa ee key s Oxygen Sensor function g Ooo OAY Calibrate OF Sense nNous you w parton O2 Sensor Allows you to perform a two point calibration of the oxygen sensor Only available before normal ventilation begins patient must not be connec
7. erformed by a trained qualitied individual Make sure an oxygen sensor is installed and securely connected to ventilator head harness Perform FlO2 calibration check Replace Oxygen Sensor Replacement of the sensor should only be performed by a trained qualified individual Page 8 of 8
8. ion in the aforementioned PB840 Addendum or Operator s Manual and Service Manual of the PB700 Series Ventilator Systems See Attachment I Covidien has validated another oxygen sensor PN 10097599 in addition to the existing O2 sensor PN 4 07221 4 00 to provide additional sensor supply options The enclosed update provides information related to both sensors and how to understand the operational life of the sensors The enclosed update also includes information related to addressing O2 sensor alarms and managing situations where the sensor may become non functional while the ventilator is being used on a patient See the excerpted information in Attachment II Attachment III and Attachment IV for additional information related to maintenance and alarms As always please ensure you are familiar with the instructions for operating your ventilator and are aware of all precautions and warnings associated with its proper use Actions to be performed in relation to this field safety notice e Read and understand the enclosed information and communicate this information to those who need to be aware of this labeling update Following this information will ensure optimal operation is achieved when using your ventilator e For the Puritan Bennett PB840 ONLY If you have Addendum PN 066009A 09 02 remove and replace with this new information Otherwise please add this new information to your current operators manual Please dispose of the Addendum P
9. nett ventilators contact your local Covidien representative at or your Technical Support Department to ensure proper device reporting procedures are followed We apologize for any inconvenience this may cause and thank you for your prompt attention to this matter Sincerely Attachment Oxygen Sensor Operational Life Labeling Update for PB840 and PB 700 Series Ventilators Attachment II Oxygen Sensor Maintenance and Alarms for PB840 Ventilator Attachment III Oxygen Sensor Replacement for the PB840 Ventilators Attachment IV Oxygen Sensor Maintenance and Alarms for PB700 Series Ventilators Page 2 of 8 COVIDIEN 11c 15 HAMPSHIRE STREET 508 261 8000 T MANSFIELD MA 02048 URGENT FIELD SAFETY NOTICE Attachment Oxygen Sensor Operational Life Labeling Update for PB840 and PB 700 Series Ventilators Please note the following important operational life and installation information related to the O2 sensors and ensure that all usage and maintenance be performed by trained and qualified personnel Part Number PN 4 072214 00 PBPB840 PN 10097559 PBPB840 PB740 PB760 PN G 062010 00 PB740 PB760 Date Code For this date code format MM YY For this date code format MM YY the the Expiration Date 10 14 means Install by 08 14 means that the sensor that the sensor is no longer useable must be installed in a Ventilator before after October 2014 It should notbe August 201
10. t the oxygen sensor calibration Operator s and Technical Reference Manual Puritan Bennett 800 Series Ventilator System Operator s and Technical Reference Manual Alarm Summary Page TR 13 20 Urgency Analysis message Base message Remedy message Comments O2 SENSOR Ventilation O2 sensor out of Background checks unaffected calibration failure have detected a Press 100 O2 CAL problem Resets when or INCREASE 02 2 operator successfully i calibrates oxygen sensor or disables oxygen sensor Puritan Bennett 800 Series Ventilator System Operator s and Technical Reference Manual Alarm Messages Pages OP 5 13 OP5 15 Low Delivered The 02 measured during any phase Check the patient the air and oxygen O2 of breath cycle is 7 12 during the supplies the oxygen analyzer and the first hour of operation or more below the 02 parameter for at least 30 seconds Calibrate oxygen sensor press 100 O2 CAL The percentage window increases by 2 min key See page TR 15 6 for information 5 for four minutes after you on calibrating the oxygen sensor increase the set 02 value ventilator Use an external O2 monitor and disable the O2 sensor Background checks have detected a Press 100 O2 CAL or INCREASE O2 2 min to problem with the oxygen sensor recalibrate the oxygen sensor sensor failure or it is out of calibration Patient ventilation is Disable the oxygen sensor unaffected Replace the oxygen sensor
11. ted NOTE Covidien recommends calibrating the oxygen sensor once a week or with each new patient 10066984 Section 6 Oxygen Sensor O Alarm Info Allows you to enable or Table 6 1 Menu disable the oxygen sensor Functions Summary O Sensor Display Allows you to enable or disable displaying the oxygen sensor reading unless an alarm is active in the message window which is updated several times per second lf the calibration is not successful contact service To continue ventilating if indicated by your institution s protocol disable the oxygen sensor select O2 alarm info from the Oxygen Oxygen Sensor Sensor Menu function Covidien 10066984 Section 6 5 recommends using an external oxygen monitor whenever the ventilators oxygen sensor is disabled Please note the following important safety reminders should an O2 sensor alarms occur during use REFERENCE SOURCE 700 SERIES VENTILATOR SYSTEM SERVICE MANUAL ALARM MESSAGES THIS MESSAGE HIGH PRIORITY ALARM Measured Check air intake filter for oxygen percentage more than 10 occlusion Replace if percentage points above setting for at necessary least 30 seconds Check oxygen supply Verify that an oxygen Auto reset when measured O2 is sensor is installed within 10 percentage points of setting Check remaining sensor life via service summary and replace sensor if required Page 7 of 8 O2 HIGH NO DIAGNOSTIC CODE LOGGED COVIDIEN 11c 15
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