Specification builder · Tier C
Ultrasonic surgical cutting and coagulation system with generator, reusable transducer handpiece and open and laparoscopic ultrasonic clamp shears
An ultrasonic surgical system uses a vibrating blade in clamp shears to cut tissue and seal small vessels in one step, with little smoke and no current through the patient. Tertiary, teaching, private and busy DHQ hospitals buy it for laparoscopic cholecystectomy, gynae, colorectal, thyroid, breast and bariatric surgery. The main tender risks are that each generator works only with its own maker's handpieces and shears, and that single-use shears and handpiece replacement cost far more over 5 years than the generator itself.
What this equipment will do
- Patients: adults and children having laparoscopic or open soft-tissue surgery (IEC 60601-1).
- Cutting and coagulation of soft tissue with ultrasonic clamp shears, with no current passing through the patient and no return plate needed.
- Sealing of vessels up to 5 mm, for example cystic artery, mesentery, thyroid and breast vessels.
- Sealing of vessels up to 7 mm with a dedicated sealing setting, for major gynae, colorectal and oncology surgery. (with the optional module)
- 5 mm laparoscopic shears of 35-39 cm through standard 5 mm trocars.
- Long laparoscopic shears of 44 cm or more for bariatric and obese patients. (with the optional module)
- Short open-surgery shears of 23 cm or less for thyroid, breast and plastic surgery. (with the optional module)
- Automatic handpiece and blade checks with output stop on blade fault or breakage.
- Automatic output adjustment from blade and tissue feedback to limit blade heat. (with the optional module)
- Fully cordless operation with reusable battery and generator module. (with the optional module)
- Advanced bipolar vessel sealing (up to 7 mm) from the same console (IEC 60601-2-2). (with the optional module)
Not covered: Ultrasonic tissue aspiration (fragmenting and sucking liver or brain tumour tissue) needs an ultrasonic surgical aspirator, a different device covered by IEC 61847.; Monopolar cutting, fulguration and ordinary bipolar coagulation need an electrosurgical generator (diathermy).; Sealing of vessels larger than 7 mm needs ligatures, clips or vascular staplers; for routine 7 mm sealing a bipolar vessel-sealing system is the alternative.; Ultrasonic bone cutting (piezo surgery) in dental, maxillofacial or spinal surgery needs a piezoelectric bone surgery unit.
Loading the builder...
Standards this specification draws on
- IEC 60601-1 General basic safety and essential performance of medical electrical equipment, including the generator, handpiece and battery-powered cordless units.
- IEC 60601-2-2 Particular requirements for high-frequency surgical equipment; applies where the generator or shears also deliver bipolar or monopolar energy (hybrid or combined platforms).
- IEC 60601-1-2 Electromagnetic compatibility so the generator does not disturb monitors and other theatre equipment.
- IEC 60601-1-6 Usability engineering so power levels, tones and fault messages are hard to misuse.
- IEC 62304 Software life-cycle for the resonance-tracking, fault-detection and output-control software.
- ISO 14971 Risk management for medical devices.
- ISO 13485 Quality management system of the manufacturer of generator, handpiece and shears.
- IEC 62353 Recurrent and after-repair electrical safety testing of medical electrical equipment.
- ISO 17664-1 Information the manufacturer must give for cleaning, disinfection and sterilisation of reusable handpieces and cables.
- DRAP Medical Devices Rules 2017 Registration required to import and sell medical devices in Pakistan.
Common mistakes in tenders for this equipment
- Writing the tender around one maker's trademarked device or feature names (for example the product name commonly used for ultrasonic shears, or a named tissue-feedback technology) instead of measurable functions; this hands the tender to one brand and its shears line.
- Comparing generator prices only: single-use shears over 5 years usually cost several times the generator, and generators are often placed free against a hidden minimum shears purchase.
- Not asking which shears and handpieces work with the generator and whether a paid software key is needed for newer shears; every system is closed to other makers' instruments.
- Forgetting handpiece replacement: handpieces have a rated life in procedures and cost thousands of dollars, so a tender that ignores them hides a large recurring cost.
- Re-sterilising and reusing single-use shears to save money; blades crack, clamp pads wear and sealing fails unpredictably, and it voids the manufacturer's liability.
- Asking for IEC 61847 compliance: that standard covers ultrasonic aspirators and explicitly excludes clamp coagulators (ultrasonic shears), so it proves nothing about the shears.
- Accepting DRAP registration of the generator only; the handpiece and every offered shears model must also be registered.
- Specifying 7 mm sealing, cordless use or tissue-feedback control by default; each removes most bidders, and 5 mm sealing covers cholecystectomy, thyroid and breast work.