UBA_Performance_Spec_Questions_as_of_08142018_Q_A.pdf

UBA Performance Spec Q&A

Questions as of 08/14/2018 (4 Total)

1. In the BASE table Item id #1. Please confirm that this is for REDACTED. Please confirm that the evaluation period is 04/01/2019 - 03/31/2020. On the Option 1 table item id#1. Please confirm the certification period is the same as the evaluation period and that consumables needs to be costed for this period. On the Option 2 table item id#1. Please confirm the certification period is the same as the evaluation period and that technical support needs to be costed for this period.

ANSWER 1:

1.

a. In the BASE table Item id #1. Please confirm that this is for REDACTED.

(CLIN 0001 is for 7 UBAs)

b. Please confirm that the evaluation period is 04/01/2019 - 03/31/2020.

(Yes)

c. On the Option 1 table item id#1. Please confirm the certification period is the same as the evaluation period and that consumables needs to be costed for this period.

(No. The certification testing will begin following the evaluation period. CLIN 4 and 5 apply)

d. On the Option 2 table item id#1. Please confirm the certification period is the same as the evaluation period and that technical support needs to be costed for this period.

(No. The certification period is not the same as the evaluation period. Note that there is no requirement for on-site technical support during the entire period, but communication with OEM may be required.)

2. For the T&E units do we need to have Berry compliant soft parts (harness etc.)?

ANSWER 2:

2. For the T&E units do we need to have Berry compliant soft parts (harness etc.)?

Yes

3. Please explain where the IAW document can be found ( IAW paragraph 4.2.1.1). Example;

3.2.1.1. Operational Duration: The UBA must provide the prescribed breathing loop characteristics for 30 minutes at a breathing rate of 36 Respiratory Minute Volume (RMV) and an additional 240 minutes at a breathing rate of 22.5 RMV when tested IAW paragraph 4.2.1.1.

(ANSWER NOT REQUIRED FOR THIS QUESTION; VENDOR SUBMITTED BELOW)

ANSWER 3:

No response required.

4. Previous question. What is IAW document is now understood. Thank you. 1. Definition 3.1 in Attachment A document defines a CO2 injection rate of 1.6l/min. This relates to an approximate ventilation (Ve) of 40m/min. Definition 3.2.1.5 defines a Ve of 90l/min which is in excess of 1.6l/min CO2. Please confirm 1.6l CO2 is the correct injection rate. 2. Definition 3.2.1.10. please define the requirement for individual components testing. The UBA comes as a complete system with no 'removable components'. The UBA will be tested complete. Please confirm. 3. Definition

3.4.2. There is no IAW 4.5 in the document.

ANSWER 4:

4.

a. 1. Definition 3.1 in Attachment A document defines a CO2 injection rate of 1.6l/min.

This relates to an approximate ventilation (Ve) of 40l/min. Definition 3.2.1.5 defines a Ve of 90l/min which is in excess of 1.6l/min CO2. Please confirm 1.6l CO2 is the correct injection rate.

(Para 3.2.1.5 is concerned only with oxygen addition to maintain ppO2 IAW Para 3.1.)

b. 2. Definition 3.2.1.10. please define the requirement for individual components testing.

The UBA comes as a complete system with no 'removable components'. The UBA will be tested complete. Please confirm.

(The UBA will be tested as a complete assembly and major components/sub-assemblies will be tested as components to allow for replacing such components/sub-assemblies.)

c. 3. Definition 3.4.2. There is no IAW 4.5 in the document.

(There is a typo in Para 3.4.2. In Para 3.4.2, “4.5” should read “4.4.2”.)

END OF QUESTIONS