Datasets:
thearod5
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InfusionPump

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R5.8.0(4)
drug label. All filled prescriptions (liquid narcotic pain-killer dispensed by the hospital pharmacy) must be labeled at least visibly with a. Patient name b. Drug Code c. Name of Drug d. Concentration e. Initial volume of drug f. Basal flow rate g. VTBI h. Minimum time between bolus i. Date prescription filled j. Prescribing physician's name k. Pharmacist name. Labels may show additional information. Labels should be difficult to counterfeit or modify without detection only created and attached to filled prescriptions by a pharmacist in the hospital pharmacy.
Requirement
R5.8.0(5)
enter prescription. Prior to or coincident with loading the drug reservoir must also enter prescription on the drug container's label using the scanner.
Requirement
R5.8.0(6)
prescription confirmation. An authorized clinician must personally confirm the prescription is authentic and meant for the patient to be infused. The routine procedures by which clinicians load the drug reservoir must ensure that the prescription lled by an authorized pharmacist at the hospital pharmacy is meant for the patient (to be) connected to the PCA pump.
Requirement
R5.8.0(8)
drug in library. The drug loaded into the reservoir must also be found in the PCA pump's drug in library. The drug code of the prescription must match the drug code of a drug library entry. The drug library must pass authenticity and integrity checks.
Requirement
R5.8.0(9)
low-reservoir warning. If the drug volume in the reservoir measures less than Vlra = 1 ml and an infusion is in progress a low-reservoir warning shall be issued.
Requirement
R5.9.0(1)
drug library. The drug library can be thought of as a lookup table that given a drug name and a location provides typical and safe limits of di erent infusion parameters. The drug library shall be determined by an authorized and authenticated hospital pharmacist and loaded into the PCA pump via its communication port after verifying its authenticity and integrity.
Requirement
R5.9.0(2)
drug library entry. For each drug that may be infused with a PCA pump the drug library entry for that drug shall have data elements listed in Table 6.
Requirement
R5.9.0(3)
drug library checking. After the clinician presses the start button but before commencing infusion the values of VTBI and Fbasal are checked against the drug library entry of the drug to be infused
Requirement
R5.9.0(4)
unknown drug. If the drug loaded into the drug reservoir is not present in the drug library or the library does not pass authentication and integrity checks that the drug is unknown or drug library error has occurred is indicated by the user interface and recorded in the Fault Log. Pump remains stopped.
Requirement
R5.9.0(5)
hard limit. If a drug library's hard limit is violated by the proposed settings the limit violated is indicated by the user interface and recorded in the Fault Log. Pump remains stopped.
Requirement
R5.9.0(6)
soft limit . If a drug library's soft limit is violated by the proposed settings but not a hard limit a warning is shown to the clinician by the user interface and a distinctive irritating sound made and recorded in the Event Log. If the clinician again confirms proposed settings then pump operation shall commence using them otherwise typical values from the Drug Library.
Requirement
R6.1.0(1)
safety architecture. The PCA pump shall implement a safety architecture that separates normal operation from fault detection and response.
Requirement
R6.2.0(1)
complete pump stroke. When the stop button is pressed the current pump stroke shall be completed prior to stopping the pump.
Requirement
R6.2.0(2)
continuous reverse delivery. During normal use and/or single fault condition of the equipment continuous reverse delivery shall not be possible (from IEC 601-2-24).
Requirement
R6.2.0(3)
air-in-line alarm. An air-in-line alarm shall be triggered by the pump if detectable air bubbles are infused into the patient.
Requirement
R6.2.0(4)
upstream occlusion alarm. An upstream occlusion alarm shall be triggered when the pump senses an upstream (drug reservoir side) occlusion exceeding Puo = 1 psi.
Requirement
R6.2.0(5)
downstream occlusion alarm. A downstream occlusion alarm shall be triggered if the pump senses a downstream (patient side) occlusion exceeding Pdo = 10 psi.
Requirement
R6.2.0(6)
occlusion alarm. When an occlusion alarm occurs the pump shall be stopped immediately without completing the current pump stroke.
Requirement
R6.2.0(7)
empty-reservoir alarm. When an empty-reservoir alarm occurs the current pump stroke shall be completed prior to stopping the pump.
Requirement
R6.2.0(8)
open door alarm. A open door alarm shall be triggered when the reservoir door is opened while the pump is not stopped.
Requirement
R6.3.0(1)
battery backup. The PCA pump shall continue to infuse for 10 minutes during interruption of mains electricity supply using battery backup either continuously or spread over an hour. (Five minutes to recharge per minute using battery.)
Requirement
R6.3.0(2)
remaining battery minutes. The user interface must show that the PCA pump is working on battery backup and an estimate of the number of minutes of battery-powered infusion remain.
Requirement
R6.3.0(3)
remaining battery accuracy. The estimate of remaining battery energy must be accurate to within Xbtty = 25%.
Requirement
R6.3.0(4)
low-battery warning. If the estimated battery life remaining is less than ?lba = 3 minutes the pump shall issue a low-battery warning.
Requirement
R6.3.0(5)
battery failure alarm. The PCA pump shall detect battery failure and issue a battery failure alarm.
Requirement
R6.4.0(1)
POST alarm. The PCA pump shall perform a power-on-self-test (POST) to assure system integrity after being turned on yet before any infusion begins. Failure of POST shall raise a POST alarm stop pump record it in the Fault Log and display the reason for failure on the user interface.
Requirement
R6.4.0(2)
self-test alarm. The PCA pump shall perform periodic self-tests to assure system integrity during long periods of use. Failure of a self-test shall raise a self-test alarm stop pump record it in the Fault Log and display the reason for failure on the user interface.
Requirement
R6.4.0(3)
continuous fault-detection. The PCA pump shall have continuous fault-detection and masking. Hardware monitors of thread heartbeat memory error correction codes are examples.
Requirement
R6.4.0(4)
single-event upsets. Occurrence of unavoidable single-event upsets caused by cosmic-ray-induced high- and thermal-energy neutrons must be either masked or detected to fail-stop.
Requirement
R6.4.0(5)
masked faults. Successfully masked faults shall be recorded in the Fault Log but raise an alarm.
Requirement
R6.4.0(6)
unmasked faults. Hardware faults detected but not masked shall raise a fault alarm stop pump record it in the Fault Log and display the reason for fault on the user interface.
Requirement
R6.4.0(7)
hardware fault indicator. Hardware faults that prevent operation of the Control Panel shall illuminate a hardware fault indicator (light-emitting diode).
Requirement
R6.5.0(1)
tamper-resistant door. Because the drugs used for analgesia are often narcotic requiring Drug Enforcement Agency (DEA) tracking if used in the United States the drug reservoir and means to change prescriptions during infusion must be inhibited with a locked tamper-resistant door.
Requirement
R6.5.0(2)
door key. Hospital procedures must endow the attending clinician access to the door key yet prevent other persons' access. Key-handling processes are beyond the scope of these requirements but much depends on the attending clinician: it's the right drug in the right patient with the right prescription from a physician authorized to prescribe narcotics for those suffering great pain. If the key is electronic some of this information may be automatically verified and authenticated.
Requirement
R6.5.0(3)
pump case. The PCA pump case must be at least difficult to breech as its tamper-resistant door. Breaking the case shall not be easier to access the drug reservoir than breeching the door.
Requirement
R6.5.0(4)
electronic tamper detection mechanisms. The PCA pump shall include electronic tamper detection mechanisms and shall record detected tampering attempts in the Fault Log and Event Log as well as issuing an authenticated ICE message.
Requirement
R6.6.0(1)
biocompatible. All materials that contact fluid shall be biocompatible.
Requirement
R6.6.0(2)
cleaned and disinfected. The PCA pump shall be cleaned and disinfected after use.
Requirement
R7.1.0(1)
clinician authentication. Clinicians authorization to operate the PCA pump must be authenticated.
Requirement
R7.1.0(2)
patient authentication. Patient's identity and admittance to the hospital must be authenticated.
Requirement
R7.1.0(3)
prescription authentication. Drug container must have a valid prescription filled by an authorized pharmacist for the particular patient to be infused by the PCA pump.
Requirement
R7.1.0(4)
drug library authentication. Drug library information shall be authenticated before it is accepted.
Requirement
R7.2.0(1)
confidentiality. Patient information must be restricted to those providing care for the patient and the patient.
Requirement
R7.3.0(1)
provisioning jack. Provisioning of initial security keys which form a root of trust must require physical connection to a jack distinct from normal operation.
Requirement
R7.3.0(2)
protected jack. The provisioning jack must be physically inaccessible except to authorized technical personnel. Jacks for test equipment must be similarly inaccessible.
Requirement
R7.3.0(3)
provisioning channel disjointness. Provisioning (or re-provisioning) shall not be possible through an ICE network.
Requirement
R7.3.0(4)
provisioning unitarily. Provisioning shall be a single unitary block-transfer.
Requirement