Module Name
LifeCare PCA™ Infusion Pump
Validation Dates
12/15/2020
Caveat
When operated in FIPS mode
Security Level Exceptions
- Cryptographic Module Specification: Level 3
- Roles, Services, and Authentication: Level 3
- Mitigation of Other Attacks: N/A
Embodiment
Multi-Chip Stand Alone
Description
LifeCare PCA™ is a Patient-Controlled Analgesia Infusion System with Full IV-EHR Interoperability.With the ICU Medical LifeCare PCA patient-controlled analgesia infusion system, you can be confident you are safely delivering the right drug at the right dose to the right patient in the right concentration. As the first and only PCA system with an integrated barcode reader and full IV-EHR interoperability, LifeCare PCA offers streamlined programming.
FIPS Algorithms
| AES |
Cert. #5766 |
| CKG |
vendor affirmed |
| CVL |
Certs. #2088, #2089 and #2090 |
| DRBG |
Cert. #2361 |
| ECDSA |
Cert. #1550 |
| HMAC |
Cert. #3814 |
| KAS |
SP 800-56Arev2 with CVL Certs. #2088 and #2089, vendor affirmed |
| KTS |
AES Cert. #5766 and HMAC Cert. #3814; key establishment methodology provides 128 or 256 bits of encryption strength |
| KTS |
AES Cert. #5766; key establishment methodology provides 128 or 256 bits of encryption strength |
| RSA |
Cert. #3069 |
| SHS |
Cert. #4588 |
Allowed Algorithms
MD5; NDRNG; RSA (CVL Cert. #2090, key wrapping; key establishment methodology provides 112 bits of encryption strength)
Hardware Versions
P/Ns 20837-04-03 and 20837-04-04 with components 810-04505-039 and 810-11438-018
Firmware Versions
CE v1.90.0.8 and MCU v7.4.0.5
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