New PAC - MEDICAL DEVICES

UBS Sheet

Equipment Name Technical Specifications Suggested - SAPS NCM Code CATMAT Code REQUIRES INTERNET CONNECTIVITY
Cold Chamber Manufacturing Material (Internal Cabinet): Stainless steel, corrosion resistant and easy to clean; Storage Capacity: minimum of 300 liters up to 400 liters, with the possibility of having between 2 to 5 drawers; Forced Air Circulation System; Emergency Dialer with temperature alarm; Continuous Temperature Monitoring; Temperature Adjustment and Control; Internal Sensors; Storage Temperature: between +2°C and +8°C; DUAL VOLTAGE. 619313 NO
Telehealth Electrocardiograph Application: Adult and Pediatric Number of Channels: 12 channels Console Screen Type: 7 to 11 inch screen with graphic display Console Model: Operation on console Power Supply: Automatic dual voltage and rechargeable battery Data Transfer: Wired and wireless Printer: With integrated printer or not specified Digital Resolution: 1 µV/LSB High Sampling Rate: Up to 32 kHz or 8,000 samples per second Detailed Analysis: - ST Map Function - Ability to identify arrhythmias - Heart rate variability analysis in the RR interval - Measurements such as HR, PR, QRS, QT/QTc, P-R-T axis Pacemaker Detection Loose Electrode Identification by Lead Computer Communication: Via USB or wireless Digital Filters: To minimize 60Hz/50Hz interference Rechargeable Battery 9018.11.00 615382 YES
Laser for Physiotherapy Low Power Therapeutic Laser (with therapeutic application in injured tissue recovery, analgesia and anti-inflammatory); Source: Diode; Wavelength: Red and Infrared; Output Power: 100 mW; Application Method: Handpiece and Support; Main System Voltage: 220 V; Operation Mode: Continuous Operation; Additional Components: Protective Glasses for the Operator and for the Patient; Must Include the Following Laser Pens (Probes): Pen with Wavelength of Approximately 904nm and Approximately 660nm; 90189099 469312 460169 NO
TENS and FES Neuromuscular Electrostimulator Device: Minimum 4 channels; Intensity Controls: Independent per channel; Additional Components: Timer, touch keypad, timer, electrodes; Power Supply: 110/220V; Additional Characteristics: TENS, FES, Russian current, interferential; Accessories: Power cable, patient connection cables, pen with cable; Independent and Isolated Channels: To allow different types of stimulation; Operation Functions: Ramp ON, OFF, rise and decay for intensity control; Waveform: Continuous, intermittent and dense disperse (possibility of frequency mixing); Repetition Frequency Adjustment: Minimum range of 0 to 100 Hz; Pulse Width Adjustment: Minimum range of 250 to 400 µs; Timer with Sound Alert: For therapy application time control and to ensure safety during therapy; Extra Accessories: 5 gel tubes, 2 spare fuses 90189099 415956 NO
Ultrasound for Physiotherapy Use: Physiotherapeutic and Aesthetic Treatment; Emission Frequency: 1 and 3 MHz; Voltage: 110/220 V; Application: Continuous and Pulsed Operation Mode; Additional Characteristics: Timer, Touch Keypad, Digital Numeric Display; Components: Minimum 7cm² Waterproof Input Transducer; Accessories: - 1 Transducer 1.0 MHz and 1 Transducer 3.0 MHz; - 1 Tube with Conductive Gel; - 1 Transport Case; - 1 Power Cable; 90189099 415965 NO

PAC Sheet

Equipment Name Technical Specifications Suggested - SAPS NCM Code CATMAT Code REQUIRES INTERNET CONNECTIVITY
Photophore - Head Light Power Type: Rechargeable lithium battery; Battery Autonomy: Minimum of 2 hours; Lamp Lifespan: About 20,000 hours; Light Intensity: 50,000 lux; Lamp Power: Minimum of 5 W; Lamp Type: High performance LED; Light Color Temperature: Between 5000K and 6000K (cold light); Light Intensity Adjustment: Has; Focus: Adjustable; Helmet Adjustment: Adjustable for head circumference and height; Power Source: 110/220V with ABNT standard power cable; Accessories: Includes transport case. 615951 NO
ANESTHESIA DEVICE WITH MULTIPARAMETER MONITOR CONVENTIONAL ANESTHESIA DEVICE 1. UTILIZATION CHARACTERISTIC AND OPERATING PRINCIPLE 1.1 Indicated for anesthesia procedures in low-weight neonatal patients to morbidly obese adults, without the need to change internal parts of the equipment and must include multiparameter monitor (item X); 2. MOUNTING TYPE 2.1 Must have a base for the equipment and its accessories, with wheels for moving the equipment and brake system, and with articulated support for the patient circuit; 2.2 Microprocessed equipment with electronically controlled ventilator. 2.3 All items that come into contact with the patient must be latex-free. 3. PHYSICAL CHARACTERISTIC/CONSTRUCTION 3.1 Main LCD screen with minimum size of 15" (fifteen) inches color 3.2 Must have keys, rotational button and/or touchscreen that allows programming of all equipment parameters; 3.3 Must have blender, microprocessed, internal to the equipment 3.4 Must have a single and universal main flow sensor for adult, pediatric and neonatal ventilation, without expiration date (the main flow sensor is defined as the flow sensor that is essential for the functioning of the equipment's basic operations) 3.5 Must have a single and universal APL valve for adult, pediatric and neonatal manual/spontaneous ventilation; 3.6 Future possibility of receiving monitor support and multiparameter monitor coupled to the equipment 3.7 FiO2 through paramagnetic sensor 4. OPERATION MODES, OPERATING RANGES AND CONTROLS 4.1 Must have, at minimum, the following Operation Modes: 4.1.1 Manual/Spontaneous 4.1.2 Volume Controlled (VC) 4.1.3 Pressure Controlled (PC) 4.1.4 Synchronized Intermittent Mandatory Ventilation (SIMV) 4.1.5 Pressure Support (PS) 4.1.6 Volume controlled with regulated pressure (PRVC, PC-VG, APV, Autoflow, Variable Pressure Control or equivalent). 4.2 Must have the following adjustment ranges: 4.2.1 Tidal Volume at least from 20 to 1000 ml. 4.2.2 Ventilation Frequency at least from 4 to 60 bpm. 4.2.3 I:E Ratio at least from 2:1 to 1:4 4.2.4 PEEP at least from 4 to 20 cmH2O. 4.2.5 Inspiratory Pressure at least from 5 to 60 cmH2O. 4.2.6 Inspiratory Flow at least from 10 to 75 L/min 4.3 Monitored parameters: 4.3.1 Minute Volume 4.3.2 Tidal Volume 4.3.3 Inspired FiO2 4.3.4 Peak Pressure 4.3.5 Mean Pressure 4.3.6 PEEP 4.3.7 Ventilation Curve of "Pressure x Time" 4.3.8 Ventilation Curve of "Flow x Time" 4.3.9 Loop of "Pressure x Volume". 4.3.10 Loop of "Flow x Volume". 4.4 Display of up to 3 waveforms (curves/loops) simultaneously. 4.5 Software with user interface in Portuguese language. 5. ALARMS AND INDICATORS 5.1 Tidal Volume (Adjustable) or Minute Volume. 5.2 Inspired FiO2 (Adjustable). 5.3 Peak Pressure (Adjustable). 5.4 Alarm system in case of loss of O2 gas supply pressure. 5.5 Low battery charge alarm system. 5.6 Manual adjustment of alarm limits. 6. SAFETY AND OTHER RESOURCES 6.1 Self-test system when turning on the equipment 6.2 Leak detection system. 6.3 Patient circuit compliance compensation system. 6.4 Anti-Hypoxia safety system, to guarantee a minimum concentration of 21% O2 in an O2/N2O2 mixture. 6.7 Module with capacity for at least 02 vaporizers, with safety system that does not allow simultaneous use of vaporizers. 6.8 Option of Isoflurane, Sevoflurane vaporizers and future possibility of installing Desflurane. 6.9 Canister must accompany the equipment 6.10 CO2 absorber assembly with reusable and transparent container, and with bypass system that allows the substitution of the absorber agent with the equipment in operation. 6.11 Flowmeter with numerical and graphical bar digital indicators of O2 flow, nitrous oxide flow and compressed air flow. 6.12 Gas Analyzer Module and all resources necessary for the operation of this tool. 6.13 Cardiac bypass system for maneuvers along with the extracorporeal pump (CEC) in both manual and automatic ventilation 6.14 Tool for measuring anesthetic agents 6.15 Possibility of future software/tool upgrade that assists in low flow therapy 7. ACCESSORIES 7.1 01 (one) transport unit, for the equipment and its accessories, with 360° swivel casters and locks on at least two of these casters, and also at least one tray and one front drawer. 7.2 01 (one) Spare reusable and transparent container used in the CO2 Absorber System. 7.3 03 (three) Complete autoclavable patient circuits for adult use (with mask, breathing tubes, balloon, valves, collectors and connectors), latex-free. 7.4 01 (one) Complete autoclavable silicone patient circuits for pediatric use (with mask, breathing tubes, balloon, valves, collectors and connectors), latex-free. 7.5 03 (three) Complete autoclavable silicone patient circuits for neonatal use (with mask, breathing tubes, balloon, valves, collectors and connectors), latex-free. 7.6 01 (one) Adult Artificial Lung for operation tests. 7.7 01 (one) Pediatric Artificial Lung for operation tests. 7.8 01 (one) Neonatal Artificial Lungs for operation tests. 7.9 01 (one) Set of braided nylon hoses with threaded connection for O2, N2O and Compressed Air medical gases, each with at least 05 (five) meters in length. 7.10 03 (Three) Spare single and universal Respiratory Flow Sensors for Adult, Pediatric and Neonatal use. 7.11 01 (one) Power Cable with at least 05 (five) meters in length. 7.12 All accessories and/or supplies must have an expiration date greater than 75% of their total period of use from the delivery date. 7.13 Multiparameter monitor according to item x. 7.14 Other accessories necessary for the perfect functioning of the equipment for the requested configurations 8. MEDICAL GASES 8.1 Supply Pressure at least from 50 to 85 psi, without the need for pressure regulators external to the equipment. 8.2 Safety system that interrupts the flow of N2O gas in case of loss of O2 gas supply pressure. 8.3 Supply of N2O, Compressed Air and Oxygen. 9. ELECTRICAL POWER SYSTEM 9.1 Energy autonomy system with minimum duration equal to or greater than 30 minutes, with internal rechargeable battery of technology without memory effect and charging coupled to the equipment. 9.2 Indicator system for equipment connected to electrical network or battery 9.3 Dual voltage (127V/220V RMS) or single-phase according to the existing voltage in the Hospital, to work on a 60Hz frequency network. 10. TECHNICAL OR REGULATORY REQUIREMENTS 10.1 Valid and non-temporary ANVISA Registration, according to the provisions of Law No. 3.660/1976, ANVISA RDC No. 751/2022 and ANVISA RDC No. 549/2021. 11. GENERAL 11.1 Warranty and technical assistance for 36 months 11.2 Operational manual in Portuguese 11.3 Technical manual in Portuguese or English 11.4 Operational training 11.5 All software must have a lifetime license, if applicable 9018.90.99 NO
SURGICAL ARCH (C-ARM) SURGICAL C-ARM 1. UTILIZATION CHARACTERISTIC AND OPERATING PRINCIPLE 1.1 Mobile surgical c-arm with digital detector for applications in general surgery, orthopedics, neurology (spine), cardiac surgery, vascular procedures. 1.2 Performance of Fluoroscopy, acquisition of digital images and patient film exports during surgical procedures 2. MOUNTING TYPE 2.1 Mobile 3. PHYSICAL CHARACTERISTIC/CONSTRUCTION 3.1 Arch with arm in "C" shape mounted on mobile base with motorized movements in the angular and orbital axis, Free Arch Space greater than 80 cm 4. OPERATION MODES, OPERATING RANGES AND CONTROLS 4.1 Movement with steerable rear wheels, brake system and movable front wheel; 4.2 Wheels with cable deflectors; 4.3 Horizontal rotation of the C-arm of at least 180º 4.4 Arch with motorized vertical movement with amplitude equal to or greater than 40 cm 4.5 Orbital rotation of the C-arm with minimum angle of 120º 4.6 Must have at least the following operating modes: 4.6.1 Auto loop for continuous and pulsed fluoroscopy sequences 4.6.2 Simple or sequential image acquisition 4.6.3 Exposure modes: Radiography / fluoroscopy (pulsed, continuous, manual and automatic) 4.6.4 Automatic Exposure Control (AEC) 4.7 Workstation 4.7.1 Monitor rotation minimum of 180º, upper tilt up and down, horizontal viewing angle minimum of 150º or higher 4.7.2 Touchscreen; 4.7.3 Automatic dose control; 4.7.4 Image rotation; 4.7.5 Freezing of last displayed image. 4.8 Software: 4.8.1 Must have all hardware, software, licenses and accessories necessary to perform the procedures, with the license being lifetime, regardless of how many times it is necessary to install and reinstall the acquisition Software. 4.8.2 Image processing software with automatic metal detection, reducing radiographic artifacts and optimizing the visualization of anatomical structures in real time 4.8.3 Radiographic images in DICOM format 4.8.4 DICOM 3.0 package (or higher version) FULL, with SEND / RETRIEVE / STORE / PRINT / WORKLIST / MPPS / HIS functions 4.8.5 DSA (Digital Subtraction Angiography) or specific subtraction feature for blood vessel visualization 4.8.6 RSA (Roadmapping Subtraction Angiography) or feature that integrates digital subtraction functionality with dynamic overlay of the subtracted image in real time, allowing the capture and use of a reference image of the vascular path for accurate navigation of medical devices during interventional procedures 4.8.7 Anatomical background visibility adjustment function (Pixel Shift) 4.8.8 Positive/negative inversion Function that allows switching the polarity of the fluoroscopic image, transforming light areas into dark ones and vice versa (Image inversion) 4.8.9 Image export: in DICOM format and other formats to at least USB. 4.8.10 Communication and integration with RIS, HIS and PACS systems. 4.8.11 Installed and licensed Windows operating system 4.9 Detectors 4.9.1 Digital image detector based on CMOS technology with flat panel sensor structure. 4.9.2 Digital detector of at least 30 x 30cm 4.9.3 Minimum Detective Quantum Efficiency of 59% (0.5 lp/mm) 4.10 X-ray tube 4.10.1 Rotating Anode immersed in insulating oil 4.10.2 Range of kV adjustment in fluoroscopy between 40 and 120kV 4.10.3 Minimum heat capacity of 300 kHU 4.10.4 Minimum cooling capacity of 85kHU/min 4.10.5 Tube temperature indicator on screen and automatic control 4.10.6 Thermal and over-current protection for the x-ray tube 4.11 Generator and control 4.11.1 High frequency with nominal power compatible with the x-ray tube current, with microprocessed control and automatic power and current control 4.11.2 Power of at least 15 kW 4.11.3 Virtual collimation without radiation emissions 4.11.4 Laser for patient positioning 4.11.5 X-ray emission indication 5. SAFETY AND OTHER RESOURCES 5.1 Firing block system in cases of overheating; 5.2 Firing system by manual activation and pedal. 6. ACCESSORIES 6.1 Kerma-area product meter (KAP or DAP) integrated to the equipment; 6.2 All accessories necessary for the perfect functioning of the equipment for the requested configurations. 7. ELECTRICAL POWER SYSTEM 7.1 Dual voltage (127V/220V RMS) or single-phase according to the existing voltage in the Hospital, to work on a 60Hz frequency network. 8. TECHNICAL OR REGULATORY REQUIREMENTS 8.1 ANVISA Registration, according to the provisions of Law No.: 6.360/1976, ANVISA RDC No.: 185/2001 and related legislation. 9. GENERAL 9.1 Warranty and technical assistance for 36 months 9.2 Operational manual in Portuguese 9.3 Technical manual in Portuguese or English 9.4 Operational training 9.5 All software must have a lifetime license, if applicable
Laser for Physiotherapy Low Power Therapeutic Laser (with therapeutic application in injured tissue recovery, analgesia and anti-inflammatory); Source: Diode; Wavelength: Red and Infrared; Output Power: 100 mW; Application Method: Handpiece and Support; Main System Voltage: 220 V; Operation Mode: Continuous Operation; Additional Components: Protective Glasses for the Operator and for the Patient; Must Include the Following Laser Pens (Probes): Pen with Wavelength of Approximately 904nm and Approximately 660nm; 9018.90.99 469312 460169 NO
RADIOTRANSPARENT ELECTRIC SURGICAL TABLE SURGICAL TABLE 1. UTILIZATION CHARACTERISTIC AND OPERATING PRINCIPLE 1. Surgical Table, electro-hydraulic, for use in surgical procedures of the digestive system, attached organs and abdominal wall; surgery of the genitourinary system; surgery of the musculoskeletal system; surgery of the circulatory system. 2. PHYSICAL CHARACTERISTIC/CONSTRUCTION 2.1 Multifunctional electro-hydraulic surgical table for various types of surgical procedures; 2.2 Must have physical structure made of stainless steel or superior material, and surgical table top made of radiotransparent carbon fiber and free of transverse bars, to allow the use of equipment with X-ray technology; 2.3 Structure with mobile base; 2.4 Column built in steel plate, covered in resistant and stainless material. 3. OPERATION MODES, OPERATING RANGES AND CONTROLS 3.1 General characteristics 3.1.1 Equipped with fixation and release system with stability guarantee in immobilization. 3.1.2 With lifting capacity of up to 360 kg normal position and at least 170 kg without any restrictions. 3.1.3 Must enable the use of lateral extenders that expand the bed, allowing its use in procedures with morbidly obese patients. 3.1.4 With emergency system that allows the continuation of procedures in case of power failure. 3.1.5 Radiotransparent top for the use of X-rays and the surgical arch without the need to reposition the patient. 3.1.6 The top must be divided into at least 5 sections: 3.1.6.1 Head, with mechanical fixation on the surgical table and padded coating; 3.1.6.2 Extender for patients with above-average height; 3.1.6.3 Back; 3.1.6.4 Pelvis; 3.1.6.5 Detachable legs, with two individual leg sections, with independent adjustments and with abduction, elevation and lowering movements. 3.1.7 Motorized kidney elevation 3.1.8 Protection degree against liquid penetration IPX4. 3.2 Activation 3.2.1 Command activation through remote control with wire and control integrated to the table 3.3 Movements 3.3.1 Movements through a safe system, without abrupt movements and jolts, and that supports what is resting on the divisions, movements of elevation, left and right lateral, trendelenburg, reverse trendelenburg, longitudinal and activation of the soil immobilization mechanism. 3.3.2 Must allow the reverse position without the need to turn the table. 3.3.3 Longitudinal movement: 300 mm (or higher). 3.4 Angles 3.4.1 Lateral inclination 3.4.1.1 Right lateral: minimum 15° 3.4.1.2 Left lateral: minimum 15° 3.4.2 Trendelenburg: minimum 25° 3.4.3 Reverse Trendelenburg: minimum 25° 3.4.4 Back adjustment 3.4.4.1 Elevation: minimum +55° 3.4.4.2 Declination: minimum -10° (nominal) 3.4.5 Leg adjustment 3.4.5.1 Descent: minimum -90° 3.4.5.2 Elevation: minimum +30° (nominal) 3.4.6 Head adjustment 3.4.6.1 Elevation: minimum +45° 3.4.6.2 Descent: minimum -40° (nominal) 3.5 Dimensions 3.5.1 Minimum bed length of 2000 mm 3.5.2 Minimum bed width without extender of 500 mm 3.5.3 Minimum bed width with extender of 650 mm 3.5.4 Minimum height of 650 mm or lower. 4. ALARMS AND INDICATORS 4.1 Must have indication for equipment connected to electrical network or battery; 4.2 Must have indication for low battery charge; 5. SAFETY AND OTHER RESOURCES 5.1 Intelligent Protection System to avoid the collision of table components during movement 6. ACCESSORIES 6.1 All accessories necessary for the perfect functioning of the equipment for the requested configurations 6.2 Narcosis arch in stainless steel; 6.3 Pair of shoulder pads in stainless steel covered in viscoelastic or polyurethane; 6.4 Pair of thigh holders with circular movements covered in viscoelastic with stainless steel fixing rod; 6.5 Pair of arm supports; 6.6 Radial fixers in stainless steel; 6.7 Renal accessories covered in viscoelastic or polyurethane; 6.8 Urological drawer for table in stainless steel; 6.9 Knee support with 01 pair of radial fixers in stainless steel covered in viscoelastic or gel cushion; 6.10 Support for instrument tray in stainless steel; 6.11 Strap for patient fixation in nylon with velcro; 6.12 Lateral extender for surgery of obese patients in stainless steel covered in viscoelastic; 6.13 Set of padding for the top in viscoelastic; 7. ELECTRICAL POWER SYSTEM 7.1 Dual voltage (127V/220V RMS) or single-phase according to the existing voltage in the Hospital, to work on a 60Hz frequency network. 8. TECHNICAL OR REGULATORY REQUIREMENTS 8.1 ANVISA Registration, according to the provisions of Law No.: 6.360/1976, ANVISA RDC No.: 185/2001 and related legislation. 9. GENERAL 9.1 Warranty and technical assistance for 36 months 9.2 Operational manual in Portuguese 9.3 Technical manual in Portuguese or English 9.4 Operational training 9.5 All software must have a lifetime license, if applicable