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10.1 | ICE Bus Adaptor translates events and data into bus transactions | Component |
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10.2.1 | Power Subsystem: Battery Provides reserve energy to operate the PCA Pump when mains power fails. | Component |
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10.2.2 | Power Subsystem: Power Control Switches between battery-backup and mains supply and detects anomalies like voltage out-of-range. | Component |
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10.3.1 | Operation Subsystem: Control Panel The control panel combines a touch panel with a speaker by which a clinician can enter and confirm configuration and see and hear alarms and warnings. is used by an authorized clinician to start and stop infusion displays the prescription read from the drug container by the scanner for confirmation or rejection. displays the PCA pump's status. allows request of a bolus by a clinician. allows entry of the clinician requested bolus duration displays alarm and warning indications sounds alerts for alarm and warning indications allows alarm inactivation displays if and how alarms are currently inactivated | Component |
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10.3.3 | Operation Subsystem: Operation Thread The operation thread performs primary pump operation control. | Component |
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10.3.4 | Operational Subsystem: Drug Library Thread The drug library thread stores the drug library provided by the hospital pharmacy and retrieves the drug record corresponding to the drug loaded into the reservoir. | Component |
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10.3.5 | Operational Subsystem: Event Logger Thread The event logger thread records all actions or events for later review or audit. | Component |
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10.3.6 | Operational Subsystem: Scanner The scanner reads an optical or RFID code on the patient clinician and the drug container that is loaded into the reservoir. | Component |
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10.4 | Security Subsystem The security subsystem performs authentication calculations of patient wrist bands clinician badges prescription labels drug libraries and messages with ICE. It will also encrypt patient data to be sent to an electronic health record system. Within the security subsystem a crypto process holds a crypto thread which controls a trusted platform module (TPM). A personal presence button must be pressed by a person for certain TPM initializations. | Component |
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10.5 | Fluid Subsystem The fluid subsystem moves drug from the reservoir to the line to the patient and is depicted in Figure 9. The drug flows from the reservoir through the upstream monitor to the pump then through the downstream monitor to the tube to the patient. | Component |
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10.5.1 | Fluid Subsystem: Pump The pump moves fluid at specified rate primes itself announces if priming fails indicates when it's too hot and halts pumping when commanded. | Component |
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10.5.2 | Fluid Subsystem: Upstream Monitor The upstream monitor measures drug flow into the pump and detects upstream occlusion. | Component |
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10.5.3 | Fluid Subsystem: Drug Reservoir The drug reservoir holds liquid drug until infused. | Component |
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10.5.5 | Fluid Subsystem: Patient Button The patient button allows the patient to request an extra bolus of drug on demand. It may be connected by wire or RF to the PCA pump so that it is conveniently located for the patient. | Component |
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10.6 | Safety Subsystem The safety subsystem works with but is distinct from the operation subsystem. The safety subsystem detects faults that may harm the patient signals an alarm or warning and stop infusion or reduces infusion to a keep vein open rate depending on the fault(s) detected. The components in the safety system are listed in Table 10 and depicted in Figure 10. | Component |
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10.6.1 | Safety Subsystem: Failure LED Hardware faults that prevent execution of thread cause the failure LED to illuminate. | Component |
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10.6.2 | Safety Subsystem: Alarm Thread The alarm thread (within the alarm process) evaluates fault signals to determine whether the infusion rate should be changed issues alarm and warning signals to be sounded and displayed by the control panel and creates fault entries to be stored in the fault log. | Component |
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10.6.3 | Safety Subsystem: Pump Fault Manager The pump fault manager determines if the measured upstream and downstream flow rates are within tolerance of the speci ed rate and aggregates other pump fault indications into a combined pump fault indication. | Component |
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10.6.4 | Safety Subsystem: Error Detector The error detector detects conditions that prevent threads from operating thus could not be detected by the alarm thread | Component |
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10.6.5 | Safety Subsystem: Fault Logger The fault logger records all errors that are detected. As such it is pure hardware that does not depend on thread execution. It also maintains a hardware real-time clock used for timestamps by | Component |
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10.7 | Functional Safety Architecture The functional safety architecture separates operation from error/fault detection with a few exceptions. This allows safety requirements to be more easily achieved and verified. Components comprising the functional safety architecture are: Upstream Monitor Downstream Monitor Pump Fault Manager Alarm Thread Error Detector Fault Logger Failure LED Power Control | Component |
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R2.4.0(1) | temperature range. The PCA pump should be able to operate within a temperature range of Tlo =10C to Thi =50C | Requirement |
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R2.4.0(2) | atmospheric pressure. The pump should be able to operate under atmospheric pressure ranging from Pmin =20 Hg tp Pmax = 35 Hg | Requirement |
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R2.4.0(3) | relative humidity. The (external) pump should be able to operate at relative humidity ranging from Hmin = 0% to Hmax =100% (non-condensing) | Requirement |
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R2.4.0(4) | splashing. The PCA pump should be able to withstand splashing (but not immersion) with water or bodily fluids | Requirement |
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R4.1.0(1) | basal flow rate. The basal flow rate Fbasal is prescribed by a physician and entered into the PCA pump by scanning the prescription from the drug container label as it is loaded into the reservoir | Requirement |
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R4.1.0(2) | basal infusion flow range. The pump shall be able to deliver basal infusion at flows throughout the basal infusion flow range of Fbasal min = 1 to Fbasal max = 10 ml/hr | Requirement |
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R4.1.0(3) | basal infusion flow tolerance. The pump shall deliver basal infusion at the prescribed basal rate within a basal infusion flow tolerance of Fbasal tol = 0.5 ml/hr of the prescribed basal rate. | Requirement |
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R4.1.0(5) | minimum KVO flow rate. The pump shall maintain a minimum KVO flow rate of FKVO = 1/ml at all times during infusion even during alarms unless the alarm also stops flow. Table 4 defines which alarms also stop drug flow completely. | Requirement |
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R4.2.0(2) | patient-requested bolus. A patient-requested bolus shall be delivered at its prescribed rate Fbolus in addition to the prescribed basal flow rate Fbasal but no more than the maximim flow rate for the pump Fmax. | Requirement |
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R4.2.0(5) | max dose warning. Patient-requested bolus shall not be delivered if infusing prescribed VTBI will exceed hard limits retrieved from the drug library for the volume of drug infused over a period of time. Pump rate shall be reduced to KVO and a max dose warning be issued. | Requirement |
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R4.3.0(2) | clinician-requested bolus. A clinician-requested bolus shall be delivered at the rate Fccb of VTBI divided by the duration chosen by the clinician ?ccb in addition to the prescribed basal flow rate Fbasal but no more than the maximum flow rate for the pump Fmax. | Requirement |
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R4.3.0(7) | max dose warning. Clinician commanded bolus shall be halted when continuinh to infuse prescribed VTBI will exceed hard limits retrieved from the drug library for the volume of drug infused over a period of time. Pump rate shall be reduced to KVO and a max dose warning be issued. | Requirement |
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R5.1.0(1) | measure drug flow. The PCA pump shall measure drug flow within a tolerance of Fmdf tol = 0.1 ml/hr. | Requirement |
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R5.1.0(2) | detect downstream occlusion. The PCA pump shall detect downstream occlusion | Requirement |
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R5.1.0(3) | detect upstream occlusion. The PCA pump shall detect upstream occlusion. | Requirement |
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R5.1.0(4) | detect air-in-line embolism. The PCA pump shall detect air-in-line embolism | Requirement |
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R5.10.0(1) | patient's wristband. The scanner shall read and authenticate information from the patient's wristband. | Requirement |
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R5.10.0(2) | clinician's badge. The scanner shall read and authenticate information from the clinician's badge. | Requirement |
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R5.10.0(3) | drug's package label. The scanner shall read and authenticate information from the drug's package label | Requirement |
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R5.2.0(1) | pump drug. The mechanical pump shall pump drug at precribed flow rates for basal bolus and KVO infusion when commanded. | Requirement |
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R5.2.0(2) | halt pumping. The mechanical pump shall halt pumping when commanded or caused in response to an alarm condition (at end of pump stoke?) | Requirement |
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R5.2.0(3) | reverse flow. The mechanical pump shall not allow reverse flow from the patient into the pump. | Requirement |
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R5.3.0(1) | device parameters. The PCA pump shall use a physician's prescriptions as device parameters | Requirement |
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R5.4.0(1) | issue alarms and warnings. The PCA pump shall issue alarms and warnings that require clinician attention | Requirement |
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R5.4.0(2) | basal over-infusion alarm. IF delivered basal flow rate exceeds the prescribed basal rate setting by more than its allowered tolerance over a period of more than 5 minutes or immediately if the pump goes into free flow the pump shall issue a basal-overinfusion alarm. (EC3.2.7) | Requirement |
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R5.4.0(3) | basal under-infusion warning. If delivered basal flow rate is less than the prescribed basal rate setting by more than its allowed tolerance over a period of more than 5 minutes or immediately if the flow stops the pump shall issue a basal under-infusion warning. (EC3.2.8) | Requirement |
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R5.4.0(4) | bolus over-infusion alarm. If delivered patient-requested bolus flow rate exceeds the prescribed patient-requested bolus rate setting by more than its allowed tolerance over a period of more than 1 minute or immediately if the pump goes into free flow the pump shall issue a bolus over-infusion alarm. (EC 3.2.7). | Requirement |
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R5.4.0(5) | bolus under-infusion warning. If patient-requested bolus is less than the prescribed bolus rate setting by more than its allowed tolerance over a period of more than 1 minute or immediately if the flow stops the pump shall issue a bolus under-infusion warning. (EC3.2.8) | Requirement |
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R5.4.0(6) | square bolus over-infusion alarm. If delivered clinician-requested bolus flow rate exceeds the calculated square bolus rate by more than its allowed tolerance over a period of more than 5 minutes or immediately if the pump goes into free flow the pump shall issue a square bolus over-infusion alarm. (EC3.2.7) | Requirement |
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R5.4.0(7) | square bolus under-infusion warning. If delivered clinician-requested bolus flow rate is less than the calculated square bolus rate by more than its allowed tolerance over a period of more than 5 minutes or immediately if the flow stops the pump shall issue a square bolus under-infusion warning. (EC3.2.8) | Requirement |
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R5.4.0(8) | pump overheated alarm. If the pump gets overheated to more than Tpoh = 55 C the pump shall issue a pump overloaded alarm | Requirement |
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R5.4.1(1) | priority. Alarm's and warning's priority shall be determined in accordance with standard IEC 60601-1-8 Medical electrical equipment- Part 1-8: General requirements for safety - Collateral standard: Alarm systems- General requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. | Requirement |
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R5.4.1(2) | alarm pump rate. Priority for alarms and warnings is shown in Table 4; warnings are low-priority alarms. The last column show the alarm pump rate to be used while the alarm is in effect. For "special" flow rates for power malfunctions see Section 6.3. | Requirement |
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R5.4.1(3) | power and battery failure. Because with either working battery or power supply can operate the pump if the battery failure alarm and either the voltage out-o-range or the power supply failure alarms the the pump rate will be off otherwise the pump rate will continue at its previous value. | Requirement |
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R5.4.2(1) | visual alarm signal. If a visual indicator is necessary for the clinicaian to identify the equipment or part of the equipment that requires clinician response or awareness at least one visual alarm signal shall be provided that 1. indicated the priority of the highest priority alarm condition; and 2. can be perceived correctly at a distance of 4 m from the PCA pump. | Requirement |
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R5.4.2(2) | alarm indicator appearance. The alarm indicator appearance shall comply with color flashing frequency and duty cycle given in Table 5. | Requirement |
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R5.4.2(3) | see alarm signal. At least one visual alarm signal shall be provided that identifies the specific alarm condition and its priority. This signal shall be perceived correctly (be legible) at a distance of 1m from the equipment or part of the equipment or from the clinician's position. | Requirement |
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R5.4.2(4) | alarm symbols. Visual alarm shall display alarm symbols from Table D.201 Graphical symbols for ALARM SYSTEMS of standard IEC 60601-1-8. | Requirement |
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R5.4.3(1) | audible alarms signals. Alarms shall cause audible alarms signals that meet the requirements of Tables 203 and 204 of standard IEC 60601-1-8 for alarm pulses bursts and harmonics. | Requirement |
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R5.4.3(2) | auditory volume. The auditory volume of audible alarms signals shall conform to Selction 201.3.3.2 | Requirement |
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R5.4.3(3) | alarm melody. The alarm melody of audible alarms signals shall conform to Table AAA.1 of standard IEC 60601-1-8 for drug or fluid delivery. \C d g" shall be used for medium priority alarms; \C d g - C d" shall be used for high priority alarms; \e c" shall be used for warnings and low priority alarms. | Requirement |
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R5.4.3(4) | harmonic components. Each tone in the alarm melody shall be composed of a minimum of 4 harmonic components in the range 300 Hz to 4000 Hz comprising an inverted 9th jazz chord. | Requirement |
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R5.5.0(16) | cancel alarm signal inactivation. The Control Panel shall provide means to cancel alarm signal inactivation | Requirement |
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R5.5.0(2) | start button. The PCA pump shall have a start button. | Requirement |
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R5.5.0(21) | tactile responses. The Control Panel confirms operation during power-on self-test | Requirement |
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R5.5.0(3) | start infusion. Upon the clinician's pressing of the start button prescribed infusion shall commence | Requirement |
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R5.5.0(5) | stop button. The PCA pump shall have a stop button. | Requirement |
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R5.5.0(6) | stop infusion. Upon the clinician's pressing of the stop button prescribed infusion shall halt | Requirement |
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R5.5.0(7) | clinician bolus request. The control panel shall allow authorized clinician bolus request and choice of duration.. clinician authentication. Required when changing prescription during infusion . patient authenticaion. Required when changing prescription during infusion. prescription authentication. Required when changing prescription during infusion (patient-to-drug match). control panel. The control panel must display currently-programmed patient data and physician's prescription. | Requirement |
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R5.5.0(9) | soft limit confirmation. Prescriptions that violate the soft limits of the drug in the drug library shall issue a visible and audible warning requiring a soft limit confirmation by the clinician. | Requirement |
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R5.5.0(1) | control panel. The control panel must display currently-programmed patient data and physician's prescription. | Requirement |
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R5.5.0(10) | hard limit. Prescriptions that violate a hard limit of the drug in the drug library shall be rejected with visible and audible indication when con rmation is attempted by the clinician. | Requirement |
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R5.5.0(11) | show alarm. The Control Panel shall visually indicate the specific problem causing the alarm condition as described in Section 5.4.2. | Requirement |
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R5.5.0(12) | sound alarm. The Control Panel shall audibly indicate the specific problem causing the alarm condition as described in Section 5.4.3. | Requirement |
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R5.5.0(13) | stop silences alarms. Pressing the stop button confirms and silences all alarms and terminates any alarm signal inactivation. | Requirement |
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R5.5.0(14) | inactivate audible alarms indefinitely. The Control Panel shal provide means to inactivate audible alarms indefinitely. | Requirement |
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R5.5.0(15) | inactivate audible alarms temporarily. The Control Panel shall provide the means to inactivate audible alarms temporarily for a predefined period of time. | Requirement |
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R5.5.0(17) | inactive auditory alarm symbol. When auditory alarms are inactive the control panel shall display an inactive auditory alarm symbol from Table D.201 Graphical symbols for ALARM SYSTEMS of standard IEC 60601-1-8. | Requirement |
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R5.5.0(18) | alert-stop-start sequence. If the same alert-stop-start sequence occurs 3 or more times in ten minutes infusion will be stopped and an audible alarm sounded. | Requirement |
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R5.5.0(19) | sound of audible alarm. The Control Panel confirms operation during power-on self-test | Requirement |
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R5.5.0(20) | display of visual information. The Control Panel confirms operation during power-on self-test | Requirement |
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R5.5.0(8) | prescription confirmation. Required when changing prescription during infusion | Requirement |
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R5.6.0(1) | event log. The PCA pump shall maintain an electronic event log to record each action taken by the pump and each event sensed of its environment. | Requirement |
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R5.6.0(2) | fault log. The PCA pump shall maintain an electronic fault log to record each fault condition and the associated alarm and/or alert issued. | Requirement |
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R5.6.0(3) | time stamp. Each log entry shall have a time stamp with its time of occurrence. | Requirement |
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R5.6.0(4) | prescription retention. The patient's prescription shall be retained for at least ?data= 96 hours after the PCA pump is turned-off and unplugged. | Requirement |
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R5.6.0(5) | log retention. Information in event and Fault Logs shall be retained for at least ?log= 1000 hours after the PCA pump is turned-off and unplugged. | Requirement |
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R5.6.0(6) | event log size. The event log shall record 30 days of typical events before overwriting oldest event records first | Requirement |
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R5.6.0(7) | fault log size. The fault log shall record at least 1000 faults before overwriting oldest fault records first | Requirement |
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R5.6.0(8) | real-time clock. A real-time clock must produce timestamps accurate to 10 ms. | Requirement |
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R5.7.0(2) | ICE alarms. The ICE interface shall transmit encrypted and authenticated alarms and warnings to the ICE system. | Requirement |
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R5.7.0(3) | ICE bolus duration. The ICE interface shall allow an authorized clinician to set the duration of clinician-requested boluses through an ICE supervisor user interface. | Requirement |
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R5.7.0(4) | ICE KVO rate. The PCA pump shall switch to KVO infusion rate upon receiving an authenticated command through its ICE interface. | Requirement |
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R5.7.0(5) | ICE resume infusion. The PCA pump shall resume prescribed infusion upon receiving an authenticated command through its ICE interface. | Requirement |
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R5.7.0(1) | ICE operating status. The ICE Interface shall transmit encrypted and authenticated current operating status to the ICE system. | Requirement |
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R5.8.0(1) | drug reservoir. The drug reservoir holds liquid pain-killer supplied by the hospital pharmacy and loaded into the PCA pump by the clinician. | Requirement |
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R5.8.0(10) | empty-reservoir alarm. If the drug volume in the reservoir measures less than Vers =0.5 ml and an infusion is in progress an empty-reservoir alarm shall be issued stopping the pump. | Requirement |
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R5.8.0(2) | reservoir contents. The drug reservoir shall measure its contents. | Requirement |
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R5.8.0(3) | reservoir tolerance. The measured drug volume shall be within Vrt = 1 ml of the actual drug volume. | Requirement |
Subsets and Splits