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C.VEN-01

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HTMC PM Procedure No. C.VEN–01 rev 2 .……........…………….CRITICAL CARE VENTILATOR

(This document was last revised on 7-13-18)

Scope: This procedure is to be used for .... Time required: 0.X man-hrs.

Test equipment and supplies required: ......

Special precautions: If there is evidence of blood or body fluid contamination make sure the device is cleaned and decontaminated before attempting to work on it.

_____________________________________________________________________________________________________
This is considered to be a potentially PM Priority 1 device because if has one or more device restoration tasks that could cause the device to fail while in use, with potentially high severity/ life-threatening consequences, if they are not performed in a timely manner) and also because it has the potential to develop one or more hidden, but discoverable, performance or safety deficiencies that could have high severity/ life-threatening consequences if not corrected in a timely manner.
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1. Verify that the device appears to be working. If it is not, check the box on the right, at the end of this line, and open a repair work order [ ]

Visual Inspection (VI) tasks) – predictive maintenance to detect any indications that components are beginning to fail.

[ ] VI1. With power off inspect the entire system for signs of damage, especially any moving parts, including any user-accessible areas that are under covers. Clean as needed. Adjust or replace any loose or damaged parts. Lubricate (if applicable) as required. Rate your finding for this task using the PHYSICAL CONDITION Finding scale described below and enter your rating (1, 5 or 9) here: __

[ ] VI2. Confirm that all markings and labeling are legible. Clean or replace, as required. Enter task rating (1, 5 or 9) here __

[ ] VI3. Check that the physical condition of the power cord and cap, including the strain relief, is OK. Check the auxiliary receptacles (if applicable). Check the circuit breaker/ fuse. Enter task rating (1, 5 or 9) here __

[ ] VI4. Inspect all cables, electrodes and transducers to confirm integrity and proper function. Enter task rating (1, 5 or 9) here __ (Serious failure [task rating = 9] here is potentially life-threatening)

[ ] VI5 Verify the integrity of the patient circuit. Inspect/ clean all gas filters, as required. Inspect/ adjust all other elements in the gas supply chain, as required. Enter task rating (1, 5 or 9) here __ (If major cleaning or adjustment required enter 9) (Serious failure [task rating = 9] here is potentially life-threatening)

[ ] VI6. Review the on-board error log/ event history for any unusual indications. Enter task rating (1, 5 or 9) here __

Device Restoration (DR) tasks – reconditioning or replacement of the device’s non-durable parts. (For specific "how to" instructions, refer to the manufacturer's PM procedure)

[ ] DR1. Check the battery, or replace it if so scheduled. Enter your rating for this task here: __ (If battery replaced per schedule, enter 1; if not scheduled and battery found to be OK enter 5; if not OK enter 9)

  • If battery replacement was not scheduled and it was no longer holding a charge [task rating = 9] this could have resulted in a high severity, life-threatening outcome

[ ] DR2. Recondition or replace any specific non-durable parts identified in the manufacturer's PM procedure. Enter task rating (1, 5 or 9) here: __ (Serious failure [task rating = F] is potentially life-threatening)

Safety Verification (SV) tasks – to detect and correct any hidden performance/ safety degradations. (For specific "how to" instructions, refer to the manufacturer's PM procedure)

[ ] SV1. If there is exposed metal that could conceivably become energized, check the continuity to ground. (< 0.5 ohm). Note your finding from this task (A, B or F), here:__ (Serious failure [task rating = F] is potentially life-threatening)

[ ] SV2. Verify that the battery charging system is operating within specifications. Note your finding from this task (A, B or F), here:__

[ ] SV3. Verify that the time/ date indication (if applicable) is correct. Note your finding from this task (A, B or F), here:__

[ ] SV4. Verify the functional performance of all controls, switches, latches, clamps, soft touch keys, etc. Note your finding from this task (A, B or F), here:__ (Serious failure [task rating = F] is potentially life-threatening)

[ ] SV5. Verify proper performance of all indicators and displays, in all modes. Note your finding from this task (A, B or F), here:__ (Serious failure [task rating = F] is potentially life-threatening)

[ ] SV6. Verify that the output gas concentrations are within spec. Note your finding from this task (A, B or F), here:__ (Serious failure [task rating = F] is potentially life-threatening)

[ ] SV7. Verify that all alarms and any interlocks operate correctly, in all modes. Note your finding from this task (A, B or F), here:__ (Serious failure [task rating = F] is potentially life-threatening)

[ ] SV8. Perform a leak test. Note your rating for the finding from this task (1, 5 or 9), here:__ (Serious failure [task rating = F] is potentially life-threatening)

FINDINGS-----------------------------------------------------------------------------------------------------------------------------------------------------

Rate the device's PHYSICAL CONDITION by giving the finding for each DR task a numerical code (1, 5 or 9), where 1 = Still good/ better than expected; 5 = About as expected; and 9 = Worn out/ serious physical deterioration.

Write in the numbers of any DR tasks with a possible high severity outcome where an out-of-spec (OOS) "9" condition was found: ____________ and provide details in the Note field below

Rate the PERFORMANCE/ SAFETY of the device by coding the finding for each SV task as an A, B or F . Where A= Passed; B= Minor OOS condition(s) was found; F= Failed

Write in the numbers of any SV tasks with a possible high severity outcome where an out-of-spec (OOS) B or F condition was found:____________ and provide details in the Note field below.

Note . __________________________________________________________________________________________________

PM FINDINGS REPORT-------------------------------------------------------------------------------------------------------------------------------------------------

[ ] Device PASSED PM (all PM Tasks with a possible high severity outcome are rated 1, 5, A or B)

When done, attach a new PM sticker indicating the next PM due date. PM interval: ___months.
Make sure all controls are set at normal positions and place a CAUTION tag in a prominent position asking the next user to verify the control settings and proper device set up before its next use.

[ ] Device FAILED PM (one or more PM Tasks with a possible high severity outcome are rated 9 or F)

This is considered to be a potentially PM Priority 1 device and if it DID NOT PASS it should be removed from service immediately.

[ ] Check here if all DR Tasks were coded 1 (This is an indicator that the PM interval may be TOO SHORT)
[ ] Check here if any DR Tasks were coded 9 (This is an indicator that the PM interval may be TOO LONG)
[ ] Check here if any ST Tasks were coded B (This is an indicator that these tasks should be considered for a future WATCH LIST)


HTMC PM Procedure No. C.VEN – 01 rev 2 ............................................... Date: _________ Initials: ________
_________________________________________________________________________________________________________
Disclaimer: This PM procedure may not reference all of the maintenance tasks specified by the manufacturer's technical or user manual. In many instances the manufacturer suggests a number of user-level tasks, such as cleaning or replacing consumables, which need to be completed. These are considered to be outside the scope of this technician-level procedure.


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