Annex A – Infusion Pump, Ambulatory
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Annex A
Technical Specifications for Infusion Pump, Ambulatory
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Technical Specifications for Infusion Pump, Ambulatory
1. Functional Requirements
1.1 The unit shall deliver fluids, including medications into a patient’s body in a controlled manner.
1.2 The unit shall be intended for use to administrate patient-controlled analgesic (PCA) to patients that can be worn by the patient (ambulatory), locked to an intravenous (IV) pole, or placed on a table top.
1.3 The unit shall deliver a bolus of narcotic analgesic intravenously, subcutaneously, or epidurally when activated by the patient.
2. General Requirements
2.1 The unit shall be :
a. compact, portable, wearable (shoulder holster or in a carrier, ie backpack), water-resistant and light-weight (not more than 600g including batteries);
b. have option for battery operated ( dry cells or rechargeable battery);
c. easy to set-up, program, operate and maintain;
d. constructed of rust-proof and corrosion-resistant material; and
e. the pump can work without having to use a stand i.e. the bag can lay flat;
f. Optional -pole mount bracket adaptor for hanging the pump on an IV pole.
2.2 The unit shall be equipped with the following features:
a. Microprocessor-based designed and controlled
b. Fully programmable by end-user
c. Selection of mode of operation
d. Adjustable bolus delivery
e. Adjustable loading dose
f. Adjustable lockout period
g. Adjustable basal infusion
h. Real time clock for record management
i. Record management. The record management shall keep track of the following events during therapy:
i. Prescription data
ii. Total volume infused and remaining
iii. History of injections and attempts
j. Facility for downloading of event records to printer and computer
k. Built-in self-diagnosis program which shall automatically detect any faults or error during operation and start-up
l. Automatic detection of type of administration sets or medication cassette reservoir used
2.3 The unit shall be equipped with audible and visual alarms and indicators for occlusion, empty medication supply, tampering and electronic malfunction.
2.4 The unit shall be equipped with various type of infusion modes but not limited to the following:
a. Continuous;
b. Patient Controlled Analgesia (PCA);
c. Intermittent;
d. Bolus;and
e. Time Programming.
2.5 The Dose-delivery system, reservoir, and the administration set shall have the capability to support therapy for at least 24 hours or more at the nominal settings.
2.6 In the event of a complete occlusion, the unit shall alarm within one (1) minute of detection at every dose-volume setting.
2.7 The unit shall designed in such a way that manual restarting is necessary following correction of an alarm condition.
2.8 The dose-volume accuracy shall be maintained while the unit is operating under back pressure less than those that cause an occlusion alarm.
2.9 The unit shall be equipped with an audible alarm that shall signal the need for reservoir refilling or replacement before the reservoir is empty.
2.10 It shall not be possible to indefinitely disable an audible alarm.
2.11 The audible alarm volume controls shall not allow the alarm to be silenced completely.
2.12 Alarms associated with a suspended state of operation shall be automatically re-enabled once normal operation resumes.
2.13 The unit shall be equipped with alarms and indicators that signal battery operation and warn of a low battery condition before the pump fails to deliver a dose or the dose accuracy degrades beyond 10%.
2.14 Electro Magnetic Interference (EMI) and Electro Static Discharge (ESD) at nominal levels shall not affect the performance and safety of the unit. The unit shall detect and indicate any resulting malfunctions.
2.15 The unit's operation and safety shall not be adversely affected by fluid spills.
2.16 Administration sets and medical cassette reservoir use with the unit shall have Luer-lock or connectors.
2.17 A brief summary of instructions, important precautions, and compatible components (manufacturer, model, size) shall be permanently and prominently placarded on the device.
2.18 The labels and markings on the unit shall be durable and shall clearly and concisely identify the functions of all switches and controls.
2.19 The unit's display shall be equipped with adjustable intensity back light for clearly visible in both high and low ambient lighting levels.
2.20 All serviceable components in the unit shall be accessible to facilitate preventive maintenance, calibration, and repair.
2.21 The unit shall have the option to connect to an external printer to facilitate hard copy record of drug delivery and dosage requests via computer.
2.22 The unit shall be designed to permit future extension or upgrades to more advanced system and capabilities.
3. Battery Requirements
3.1 The battery shall provide power for at least 70hours at 30ml/hours to 260hrs at 0.4ml/hours
3.3 The unit shall fully conform to IEC/EN 60601.1 Safety standard and shall be of Class I Type CF equipment if using AC adaptor for charging the rechargeable battery.
3.4 Optional AC adaptor and rechargeable battery pack shall be quoted.
4. Safety Requirements
4.1 The construction of the unit shall ensure a sufficient degree against safety hazards caused by overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilisation and disinfection.
4.2 The enclosure shall be secure and provide adequate protection against moving and electrically energised parts.
4.3 Switches and controls should be protected against penetration of fluids.
4.4 Switches and controls shall be protected against accidental setting changes.
4.5 The controls (i.e. switches, knobs, etc.) should be visible and clearly identified, and their function should be self-evident. Device design should prevent misinterpretation of displays
and controls settings.
4.6 The unit should resist tipping over during use and transport.
5. Standards
5.1 The system shall fully conform to the following:
a. IEC/EN 60601-1, General safety requirements for medical electrical equipment;
b. IEC/EN 60601-1-2, Standard for Electromagnetic Compatibility – Requirements and tests;
c. IEC/EN 61000-4-x series, Safety requirements and tests for Electromagnetic Compatibility, Immunity;
d. IEC/EN 60529 (1989), Degrees of protection provided by enclosures (IP code).
e. International available standards in the particular requirements for safety and performance of the tendered Article(s);
f. Healthcare 7 (HL-7 layers) that formalise the methods of data formatting so that exported datas can be understood by the receiving system and between multi- vendors systems;
g. ISO 8536-4 (1987) requirements for Infusion equipment for medical use;
i. AAMI ID26-006-MM (1992) standards for Infusion devices; and
j. FDA clearance;
5.2 Contractors have to comply with Health Science Authority (HSA) Medical Device Regulation requirements for all classes of medical devices. A copy of the HSA registration certificate must be submitted together with the tender submission.
6. Technical Requirements
6.1 The Contractor shall furnish full technical specifications of the tendered Article together with the tender submission.
6.2 Minimum delivery rate, continuous : 0.1 to 500 ml/h in incremental steps of 0.1 adjustable ml/hr
6.3 Preset delivered volume, adjustable : 0.1 - 9999 ml in incremental steps of 1 ml.
6.4 Flow rate accuracy : £ ± 2 %
6.5 Occlusion detection, adjustable : £ 18 psi
6.6 Air detection : ³ 0.01 ml
6.7 Priming Rate : 250 ml/hr
6.8 The unit shall be equipped with a keep vein open function, activated upon completion of delivery.
Keep-vein-open flow rate of between 0.1 - 10 ml/hr
6.9 Pump Mechanism : Rotary Peristaltic
6.10 Battery Operation : > 70 hours at 30 ml/hr
7. Standard Accessories
7.1 All standard accessories required for the safe and smooth operation of the unit, shall be included with itemised prices and included in the unit base price.
8. Optional Accessories
8.1 Any other optional accessories and upgrades available with the unit shall be listed separately with itemised prices.
9. Installation / Commissioning Requirements
9.1 The Contractor shall inspect the site and fully acquaint himself with the nature of the work and the local conditions and facilities available, including water, drainage, ventilation and air-conditioning, where the Article is to be installed, before submitting his tender. He should also utilise other means he may prefer or consider necessary in order to fully ascertain other matters, site accessibility to equipment, conditions or constructions that may have a bearing on, or in any way affect the preparation of his tender. No claim for extra payment will be entertained by the Hospital owing to the Contractor’s neglect in this regard and any unforeseen difficulties for which provision is not made. This will in no way relieve the Contractor from the full execution of all works necessary to complete the installation. A Contractor, by the fact of submission of a tender, shall be deemed to have accepted all conditions and stipulations of this clause, which shall be binding on the Contractor.
9.2 For the testing & commissioning and thereafter for the warranty preventive maintenance & corrective maintenance or on service contract preventive maintenance & corrective maintenance, the contractor shall be represented by competent staff, suitably equipped with all necessary calibrated test and measuring instruments including electrical safety analyser with printout, who shall test and commission or performing the preventive maintenance the Articles in the presence of and to the satisfaction of the Company’s authorised representatives. The Contractor must perform the electrical leakage safety test for the equipment during commissioning and for every preventive maintenance servicing during warranty preventive maintenance & corrective maintenance or on service contract preventive maintenance & corrective maintenance with no cost to the hospital. ( Please refer SCC.3, Clause 11 for details )
9.3 The testing and commissioning of the Article shall be in accordance with clause 11 of *SCC.3 called under Material Management Department. No payment shall be made if any of the stated requirements under this clause were not met. Notwithstanding the incomplete acceptance of the Article, the Company has the right to utilise the Article while waiting for any incomplete supply , measurements , testing and training to be delivered.
9.4 All mains operated electrical Articles shall be complete with suitably insulated and sheathed three-core hospital grade flexible power cords of voltage and current rating appropriate to the Articles. Article for operating theatre shall be supplied with flexible power cords each of not less than 5m length, although the exact length shall be negotiable later. The flexible power cord shall be fitted with three-pin, high impact, unbreakable nylon body electrical plug meeting BS 1363/A or equivalent. The plug shall be of good quality consistent with hospital safety, moulded construction type and shall be equivalent to “Volex V.1307W”, BICC 3583-07”, or MK Toughplug”, 13A nylon unbreakable plugs. The plug shall be wired in conformance with sub-clause 6.5 of IEC 60601-1.
10. Additional Requirements
10.1 The supplied equipment and accessories must be of hospital-grade and shall comply with national and internationally recognised Standards and applicable Standard Systems.
10.2 The Contractor shall provide test certificates from an internationally recognised testing body attesting to compliance with recognised standards. * If certificates for the STATED compliance are not provided during the submission, it shall be considered as non-compliant to the standard.
10.3 The Contractor is expected to equip with all necessary test tools and successfully commission the Article 14 days from the date of delivery. Failure of which the Company has the right to return the Article to the Contractor. No claim for payment will be entertained by the Company. A Contractor, by the fact of submission of a ender shall be deemed to have accepted all conditions and stipulations of this clause, which shall be binding on the Contractor.
10.4 The testing and commissioning of the Article shall be in accordance with clause 11 of *SCC.3 called under Material Management Department. No payment shall be made if any of the stated requirements under this clause were not met. Notwithstanding the incomplete acceptance of the Article, the Company has the right to utilise the Article while waiting for any incomplete supply to be delivered.
10.5 The Contractor should be a direct representative/distributor of the manufacturer for all Articles including accessories.
10.6 The Contractors shall submit a letter of appointment from the manufacturer as sole agent in Singapore for the articles offered. The Contractor shall also specify:
a) The number of years that they have been appointed agent; and
b) The expiry date of the current agency agreement;
c) The expected date of discontinuation of this product.
10.7 All mains operated electrical Articles shall be complete with suitably insulated and sheathed three-core hospital grade flexible power cords of voltage and current rating appropriate to the Articles. Article for operating theatre shall be supplied with flexible power cords each of not less than 5m length, although the exact length shall be negotiable later. The flexible power cord shall be fitted with three-pin, high impact, unbreakable nylon body electrical plug meeting BS 1363/A. The plug shall be of good quality consistent with hospital safety and shall be equivalent to “Volex V.1307W”, BICC 3583-07”, or MK Toughplug”, 13A nylon unbreakable plugs. The plug shall be wired in conformance with sub-clause 6.5 of IEC 60601-1.
10.8 The warranty shall cover unlimited breakdown service calls, calibration and software upgrades, at no additional cost. The preventive maintenance of the unit shall be in accordance with the manufacturer's procedure and interval. The regular preventive maintenance shall include testing in compliance to IEC 60601.1. The Contractor shall at the time of submission, provide a copy of the preventive maintenance checklist, method and procedures. The Contractor shall provide back-up units during the warranty period while the unit is undergoing corrective repair by the Contractor.
10.9 In the event of equipment breakdown and the downtime exceeds 24 hours, the Contractor shall be responsible for arranging a loan unit of similar capacity to be used by the Company. All cost shall be borne by the Contractor.
10.10 The successful Contractor shall provide appropriate In-service training for Physicians, Nurses, Clinical staff, Laboratory Technologist, etc and Technical Service Training for Biomedical Engineers/Technicians. A qualified full time trainer shall conduct the training. In-service training shall be provided by qualified clinical instructors who are not sales personnel. Technical service training shall be provided by a qualified engineer. The technical service training shall be comprehensive and provided to a level such that the Company’s nominated service personnel are able to: