Urgent Field Safety Notice
Contents
1. GCIOS 1 0 29564 1901 Restart Table 1 USB Flash Drive Software 16 If software fails to install an icon on the GCI will show next to the failed application see figure 9 on page 5 Figure 9 Software Failure to Install fet Home Progressa Dec 4 2013 12 00 PM Software Package 179 Nov 11 2013 os al Currently Installed To Install ae Upper Control App 1 16 0 0 1 16 0 0 X SideCom App 1 6 0 0 1 6 0 0 wT Air Control App 12800 1 32 0 0 e OIML Scale App Pneumatic Control App 1 6 0 0 1 6 0 0 wi Failure GCI App 15 0 0 15 0 0 WH GCIOS 10 29664 1901 Restart History March 20 2014 184589 REV 1 Page 5 of 7 17 If the software failed to update press Update to start again If the software fails to install a second time contact Hill Rom Technical Support 18 Disconnect the bed from AC power 19 Remove the flash drive 20 Install the USB connector cover B and screw A see figure 1 on page 1 21 Connect the bed to AC power 22 Ifyou did step 11 set switch 1 on dip switch SW4 to OFF and calibrate the scale See Scale Calibration EN45501 Class Scale in the service manual 23 Do the Function Checks in the service manual Page 6 of 7 184589 REV 1 March 20 2014 NOTES March 20 2014 184589 REV 1 Page 7 of 72. file missing or invalid Could not determine frame type Restart History Restart Configuration Error Frame Type Error Page 2 of 7 184589 REV March 20 2014 9 Press the Home Screen button see figure 4 on page 3 Figure 4 Update Home Screen fet Home Progressa Dec 4 2013 11 54 AM Software Package 179 Nov 11 2013 Currently Installed To Install E N Upper Control App 11600 11600 Af SideCom App 1 6 0 0 1 6 0 0 va Air Control App 1 28 0 0 1 32 0 0 w OIML Scale App J J ate Pneumatic Control App 15 0 0 16 0 0 ne Gap 1500 1500 wW GCIOS 1 0 29564 1901 1 0 29564 1901 w Restart History 10 The screen will show the software that needs updated see figure 5 on page 3 Figure 5 Software Update Indentification Firmware software update not required Firmware software update required Firmware software update required Hardware switch disables the updates Firmware software update required P C board in bootloader mode P C board was not located on the CAN network Firmware software for the P C board is missing on the USB device Firmware software on USB device s not compatible with the P C board Firmware software installation for the P C board failed 11 If the OIML Scale App is being updated get access to the scale board and set switch 1 on dip switch SW4 to the ON position See Scale Board NAWI Compliant EN 45501 in the service manual March 20 2014 184589 REV 1 Pa
3. show on the top end 21 Install four NEW snaps to replace the ones that were removed earlier 22 Attach the cushion to the substrate 23 Make sure the straps are properly aligned over each side of the top bladders March 20 2014 181397 REV 1 Page 3 of 4 24 At the GCI do as follows Disable Seat Deflate In Normal mode run the Turn Assist function for both sides and verify that they operate correctly C While each side is inflated go into the Service menu select Surface Service Bladder Pressure and monitor the pressure to check for leaks 25 After you are sure everything is working as designed replace the fire barrier ticking and topper 26 Atthe head end of the mattress find the serial number tag Use a permanent marker to write 1220 on the tag This will verify that the mod has been completed for future ref erence Page 4 of 4 181397 REV 1 March 20 2014 Progressa Bed Software Upgrade Instructions Tools T15 Torx screwdriver Parts required 1 184607 REV 1 USB flash drive with software Reference Documents Progressa T Bed Service Manual 171748 NOTE Updating the GCI application will reset all patient data on the bed Raise the bed to the full up position Make sure the brakes are set Make sure the patient is not on the bed Make sure the bed is connected to AC power Make sure the GCI 1s active oe a oe te A and USB connector cover B see figure 1 on page 1
4. the corrective action Hill Rom confirms that the relevant Competent Authorities have been informed of this Field Safety Corrective Action Contact reference person If you have any questions concerning this Urgent Field Safety Notice please contact Hill Rom Technical Support your Distributor or your Hill Rom Representative Regards Hill Rom Technical Support Attachment Customer Response Form Receipt QS10051 REV 5 181396 REV 1 GD QS06386 Customer Response Form Receipt Subject Progressa Bed Mattress CLRT and Turn Assist Correction Mod 1220 It is imperative that you return this form receipt for our records Please complete and return this form receipt within 30 days See specific instructions at bottom of page Thank you Hill Rom account number Name of the facility Address of the facility City State Zip Facility Authorized Name Please print legibly Signature Date 7 Title Phone Email Fax Check applicable box es 1 We acknowledge receipt of this notification and it has been forwarded to all users C Other Return this form to QS10051 REV 5 181396 REV 1 GD QS06386 Subject Progressa Bed Turn Assist Bladder Replacement Instructions Tools required Window cleaner Side cutters Rags Parts required 1 185440 Service Kit TA Bladder Assembly kit contains 4 0010080019 Rivet snap female 4 0010080021 Rivet snap male 1 170004 Seat turn ass st bladder ass
5. 520A25 P7520A28 P7520A29 P7520A30 e P7520A32 P7520A33 P7520A35 P7520A37 P7520A41 P7520A43 P7520A45 The following guidelines are to be used for identifying units to be modified e For bladder replacement units production dates up to and including 06 Feb 2014 or serial numbers up to and including PO37 MW5939 e For software upgrade units production dates up to and including 11 Nov 2013 or serial numbers up to and including 0315MWxxxx NOTE If the serial number in the database is missing or erroneous you will have to refer to the date of manufacture on the mattress tag Timing e For the software correction the parts are available at this time e For the bladder replacement supply is limited and will be limited until July 31 2014 You may receive fewer units than are needed in the beginning to allow us to supply multiple regions with parts Please coordinate the orders and shipment of parts with your Hill Rom Representative Contact reference person If you have any questions concerning this request or the procedure as outlined please contact your local retrofit coordinator Regards Hill Rom Technical Support Attachment 181396 REV 1 or applicable translation 181397 REV 1 184589 REV 1 QS10051 REV 5 186268 REV 1 GD QS06386 Urgent Field Safety Notice Subject Progressa Bed Mattress CLRT and Turn Assist Correction FCA identifier Mod 1220 Type of action Device Modification Date T
6. Figure 1 USB Connector n 7 Insert the flash drive in to the USB port On the patient right side of the bed next to the pendant connector remove the screw e After approximately 1 minute the Hill Rom logo screen will show see figure 2 on page 2 After approximately 2 minutes the Update screen will show 1 Torx is a registered trademark of Acument Intellectual Properties LLC 2 Progressa is a trademark of Hill Rom Services Inc 2013 by Hill Rom Services Inc ALL RIGHTS RESERVED No part of this text shall be reproduced without written permission from Hill Rom Services Inc March 20 2014 184589 REV 1 Page 1 of 7 Hill Rom Figure 2 Logo and Update Screen fet Home Progressa Dec 4 2013 12 47 PM Software Package 179 Nov 11 2013 Currently Installed To Install Upper Control App 1 16 0 0 J 1 16 0 0 WT SideCom App 1 6 0 0 J wT Air Control App 1 32 00 OIML Scale App B Pneumatic Control App 16 0 0 J i GCIApp 1500 J GCIOS 1 0 29564 1901 1 0 29564 1901 JENS Hill Rom Production Version 1 0 29564 1901 Wed Jun 26 2013 01 42 PM Base Ver 3 Jan 4 2013 Display 1 Ver 2 Jan 4 2013 Display 2 Ver 2 Jan 4 2013 Restart History 8 If an error shows on the GCI press the Restart button see figure 3 on page 2 Figure 3 Error Screens _ fet Home Unknown Frame Dec 4 2013 12 41 PM fet Home Unknown Frame Dec 4 2013 12 32 PM Platform configuration
7. Urgent Field Safety Notice Subject Progressa Bed Mattress CLRT and Turn Assist Correction FCA identifier Mod 1220 Type of action Device Modification Date To Hill Rom Authorized Distributor Affected Devices Progressa Bed Mattress Models Affected P7520A3 P7520A7 P7520A11 P7520A15 P7520A19 P7520A21 P7520A22S P7520A23 P7520A24S P7520A31 P7520A39 P7520A47 Models NOT Affected P7520A1 P7520A2S P7520A4S P7520A5 P7520A6 P7520A8 P7520A9 P7520A13 P7520A17 P7520A18 P7520A20 P7520A22 P7520A24 P7520A25 P7520A28 P7520A29 P7520A30 P7520A32 P7520A33 P7520A35 P7520A37 P7520A41 P7520A43 P7520A45 Production Dates prior to February 7 2014 Background Hill Rom has become aware that some models of Progressa bed mattresses have a potential to not operate according to design specifications therefore we are issuing a field corrective action to be taken on units in the field Action to be taken Please forward the applicable language translation of the English version customer letter 181396 attached to your accounts that have affected product Other languages are available from Hill Rom Please contact your Hill Rom representative to receive the required translated copy of the customer letter Note that the customer letter indicates that Hill Rom will visit the customer s facility to modify their units We are expecting you to take on that role according to the terms of your contract Plea
8. away from the foot section to view the lower bladders see figure l on page 2 NOTE The area shown in the photo below is aligned approximately at the foot end of the interme diate siderail 11 Remove and DISCARD the four snaps 2 on outer sides 2 upper and lower middle that attach the turn assist bladder to the substrate 12 Slide the turn assist bladder out from under the support cushion flip it over and onto the foot section see figure 2 on page 3 13 Disconnect the two fill hoses and two smaller sense lines from the couplers 14 Remove and DISCARD the turn assist bladder 15 Place the new turn assist bladder marked Rev 4 from the kit onto the foot section in the same orientation NOTE For the following steps to assist installation use window cleaner to moisten the couplers Page 2 of 4 181397 REV 1 March 20 2014 Hill Rom 16 Install two 3 8 to 3 8 couplers onto the center ports 17 Install two 1 4 to 1 8 couplers onto the outer ports Figure 2 From Foot End New Bladder Turned over onto Foot Section 18 Lightly spray the ends of the fittings with window cleaner 19 Attach the fill and sense hoses to the couplers GREEN patient right YELLOW patient left 20 Flip the new bladder over and reposition it under the support cushion as before Make sure the sense hoses run under the bottom NOTE When the new bladder is replaced under the support cush ion the REV 4 marking should
9. entering mode of the CLRT approximately a 10 second window the software may begin to inflate and deflate the left Turn Assist bladder every two to three minutes There is no indication that the bed mattress is not functioning properly other than the left Turn Assist bladder continues to inflate and deflate every two to three minutes Hill Rom has evaluated the above two issues and has determined that it is not likely for either issue to cause an adverse health consequence Action to be taken You may continue to use your bed mattress until Hill Rom or a designee visits your facility to update your affected bed mattress with either a software update a mattress repair or both depending upon the model of integrated surface you have installed The software update will require approximately 15 minutes per bed mattress and the mattress repair requires approximately 35 minutes per unit The bed must be unoccupied for the mattress repair QS10051 REV 5 181396 REV 1 GD QS06386 If you encounter the 31C9 error readjust the patient on the mattress surface and then cycle the power of the bed to reset the system by unplugging and plugging in the power cord If you notice that the Left Turn Assist is unintentionally inflating and deflating every two to three minutes the Caregiver can select another therapy mode other than normal or cycle the power to the bed by unplugging and plugging in the power cord Please complete and return the attached Cust
10. ge 3 of 7 Hill Rom 12 Press the Update button the screen shows the progress of the update see figure 6 on page 4 e Figure 6 Software Update In Process fet Home Progressa Dec 4 2013 12 24 PM Software Package 179 Nov 11 2013 Currently Installed To Install Upper Control App 1 16 0 0 1 16 0 0 SideCom App 1 6 0 0 J 1 6 0 0 J Air Control App 1 28 0 0 1 32 0 0 OIML Scale App J B gt Pneumatic Control App 1500 J 16 0 0 J 36 0 GCI App 15 0 0 J 15 0 0 J Ww GCIOS 1 0 29564 1901 J _ 1 0 29564 1901 v Updating Q Restart History NOTE e It may take up to 10 minutes to update the software and any bed restarts 13 After the updates are finished the screen will show the software that was updated see figure 7 on page 4 Figure 7 Installation Results Software Package Installation Results CYCLE AC POWER TO COMPLETE SOFTWARE INSTALLATION Air Control App Application update successful Pneumatic Control App Application update successful 14 Press the Close button to exit the screen 15 Make sure the software version shown on the GCI matches the software version on the USB flash drive see figure 8 on page 5 Page 4 of 7 184589 REV 1 March 20 2014 Hill Rom Figure 8 Software Version Software Package 179 Nov 11 2013 Currently Installed Upper Control App 1 16 0 0 SideCom App 1 6 0 0 Air Control App 1 32 0 0 OIML Scale App 1 6 0 0 Pneumatic Control App 1 5 0 0 GCI App 1 5 0 0
11. o Chief Executive Facility Risk Manager Facility Administrator Facility Engineer Vigilance Manager Biomedical Engineering Medical Device Liaison Officer Affected Devices Progressa Bed Mattress Models Affected P7520A3 P7520A 7 P7520A11 P7520A15 P7520A19 P7520A21 P7520A22S P7520A23 P7520A24S P7520A31 P7520A39 P7520A47 Models NOT Affected P7520A1 P7520A2S P7520A4S P7520A5 P7520A6 P7520A8 P7520A9 P7520A13 P7520A17 P7520A18 P7520A20 P7520A22 P7520A24 P7520A25 P7520A28 P7520A29 P7520A30 P7520A32 P7520A33 P7520A35 P7520A37 P7520A41 P7520A43 P7520A45 Production Dates prior to February 7 2014 Background Hill Rom has become aware that certain Progressa bed mattresses may have potential for an error to occur during Turn Assist mode An error code 31C9 may be displayed on the graphical user interface and the wrench light will turn on indicating service required The 31C9 error means the Turn Assist bladder is unable to hold the required pressure to operate as intended This seems to occur more frequently with higher weight patients 136 kg 300 Ib who are very immobile and when the head section of the bed is set at 30 degrees or higher These conditions can cause air to be trapped in a sense line within the mattress causing the error Another potential issue can occur when exiting Continuous Lateral Rotation Therapy CLRT If the caregiver selects the stop therapies function during the c
12. omer Response Form Receipt within 30 days NOTE When our technicians visit they will have information to help determine which specific units are affected at your facility so you do not need to search for them However if needed the mattress date of manufacture model and serial number are on the tags attached to the head end of the mattress TTS WIS LUNDUINET Ne faz Son au con ivraison This article contains NEW MATERIA ONLY k Cet arti i Manufactured by AON ILL ROM INC MATERIAUX NEUFS os STATE ROUTE 46 BAST R SEULEMENT BATESVILLE IN 47006 U I This label is affixed in comp oo with Provincial Law 2108 DATE OF MANUFACTURE Cette tiquette est appos e 03 Jun 2013 ___gonform ment la loi de la province ODEL PR eee y p7520A21 utactured ae HILL ROM INC 4 Per Pee u NTESVILLE IN 47006 USA 08T 0106902 N de permis OTOTYPE ID n p7520A24S Important The Customer Response Form Receipt provides Hill Rom with the means to monitor the progress of Field Corrective Actions It is imperative that you return this form receipt for our records Transmission of this Field Safety Notice Please pass this notice on to all those who need to be aware within your organization and or to any organization where the affected devices have been transferred Please maintain awareness of this notice and resulting action for an appropriate period to ensure effectiveness of
13. se work with your retrofit coordinator as needed during this correction Parts will be sent to you as they are available and we expect all parts to be shipped by the end of July Please be aware that the instructions needed for completing the field correction have also been translated and can be ordered If required indicate the languages needed for the instruction sets The English versions of the instructions are attached here Due to some data missing from the database the following should be used to help you determine which units models will need to have which correction QS10051 REV 5 186268 REV 1 GD QS06386 The following mattress models will only need the bladder replacement Use the Progressa Bed Turn Assist Bladder Replacement Instructions for the bladder sense line issue e P7520A3 e P7520A e P7520A11 e P7520A15 The following mattress models will only need the software upgrade Use the Progressa Bed Software Upgrade Instructions to upgrade affected beds software e P7520A21 e P7520A22S The following mattress models may need both the bladder replacement and software upgrade if they fall in the applicable date range as defined below e P7520A19 e P7520A23 e P7520A24S e P7520A31 e P7520A39 e P7520A47 The following mattress models do not need either modification P7520A1 P7520A2S e P7520A4S P7520A5 P7520A6 P7520A8 P7520A9 P7520A13 P7520A17 P7520A18 P7520A20 P7520A22 P7520A24 e P7
14. y 2 185425 Coupler barbed reducer 6 35 3 18 2 66262 Fitting 375 x 375 barbed Reference Documents Progressa Bed System Service Manual 171748 Removal amp Replacement A WARNING Failure to set the brakes could cause injury or equipment damage A CAUTION Use care when you disconnect the hose from the fittings Excessive force can damage the fitting In these procedures you will need to disconnect hoses from the bladder fittings Use care when you do this For easier disconnection put the wire cutters between the fittings and hose then wiggle the wire cutters back and forth to loosen the hose enough for easy removal Make sure there is no patient on the bed Set the brakes Raise the bed to a comfortable working height Remove linens from the mattress Unzip the MCM topper to disconnect the two hoses at the foot end to the topper Remove the MCM topper Unzip and remove the top ticking Pull the fire barrier down to the seat foot section to expose the seat section Se ot es ee eS E Use the GCI to activate Seat Deflate NOTE The seat will remain deflated for 30 minutes 1 Progressa is a trademark and MCM a registered trademark of Hill Rom Services Inc 2014 by Hill Rom Services Inc ALL RIGHTS RESERVED No part of this text shall be reproduced without written permission from Hill Rom Services Inc March 20 2014 181397 REV 1 Page of 4 Hill Rom 10 Pull the seat section
Download Pdf Manuals
Related Search