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ITB14/00855 Annex 1 to Section 3 (amended)

1. ITEM 14 FETAL HEART DETECTOR 4 With integrated battery charger or ext charging station Consumables if any covering 1200 patients Warranty and Service 24 months from the moment of installation 14 4 eu z 7 Conditions Maximum response time at beneficiary site 72 hours Training for at least 2 medical personnel on site at beneficiary location in Russian language 14 5 incidental Services nae for at least 2 technical personnel on site at beneficiary ocation in Russian language Installation User manual in English or translated into Russian language Item Quantity ITEM 15 CARDIOTOCOGRAPH 3 1 Compliant to EU Medical devices Directives CE Mark 2 Compliant to IEC 60601 and amendments for Medical electrical 15 1 Standard requirements eaiipment ISO 9001 certified companies Standard requirements Fetal monitor for prenatal labor and delivery monitoring LCD or LED display Built in thermal recorder and printer Dual Ultrasound Twins available for reliable non stress testing and routine labor monitoring Color display and keyboard or similar for entry of patient name and ID with numerical presentation of FHR and UA Tachycardia and bradycardia alarm management Adjustable alarms 15 2 Characteristics Water proof ultrasonic transducers Backup memory Fetal Heart Rate Monitoring Ultrasonic measurement for fetal hear rate FHR with pulse Doppler technology Audible alarm and visual messages based on physiological alarms Transmitter f
2. Tube leak in Humidifier Microprocessor controlled Heater wire for in and expiratory limb possibility Reusable and autoclavable humidification chamber Dual Servo controlled principle for temperature control Miscellaneous Operating Environment Temperature approximately 10 40 C Humidity approximately 10 90 non condensing Connectors for medical gases All connectors must compatible to EN ISO 7396 DIN 13260 2 Trolley minimum 4 wheels 2 with brakes Bracket for humidifier 2 3 Accessories and Consumables The following items must be included in the cost of the unit Durables Reusable ventilator circuits pediatric neonatal with heater wire and water traps in line and nebulizer circuit 5 pcs Reusable and autoclavable humidification chamber 5 pcs Oxygen sensor 1 pcs Flow Sensor reusable 1 pcs Consumables Single use circuits pediatric neonatal with humidification chamber included 50 pieces External oxygen amp compressed air tubing Test lung Shelf mount kit Spare diaphragm for expiratory valve 2 4 Warranty and Service Conditions 24 months from the moment of installation Maximum response time at beneficiary site 72 hours Item Quantity ITEM 2 PEDIATRIC INF ANT VENTILATOR 1 2 5 Incidental Services T
3. Air Oxygen deviation Low battery Power failure Air and Oxygen supply failure Air and Oxygen low pressure Graphics Display All parameters and functions of the offered unit shall be available ona graphics screen Preferable 5 selectable waveforms shall be displayed at any time on the graphic display screen The graphics display system shall have freeze capabilities The offered unit shall have the capabilities to display trending of at least 24 hours on parameters of pressure flow and tidal volumes The offered unit shall offer a graphical display unit that is able to display the following parameters and measurements Inspired tidal volume in ml Inspired tidal volume in ml Spontaneous tidal volume in ml Item __ Quantity _ ITEM 2 PEDIATRIC INF ANT VENTILATOR 1 Total breath rate in bpm Spontaneous breath rate in bpm Minute volume in liters Spontaneous minute volume in liters Peak airway pressure in cmH20 Mean airways pressure in cmH20 E ratio Set lE ratio Inspired time in seconds Static airways compliance in ml cmH20 Dynamic airways compliance in ml cmH20 Dynamic airways compliance per kg in ml cmH20 Peak inspired flow rate in l m Peak expired flow rate in l m Inspired O2 in
4. Sealing plug for respiration catheter Adaptor with sliding glass window plug sealing cap notched lens and keyhole opening moveable Cold light fountain lamp lifetime min 500 h Please specify Fiber optic light cable length between 290 300 cm between diameter 3 4 3 6 mm 20 3 Accessories Consumables Forceps pointed serrated for coins and flat foreign bodies double action jaws sheath diameter compatible with bronchoscope 1 pcs 26 Item Quantity ITEM 20 BRONHOSCOP 1 Forceps for peanuts and soft foreign bodies double action jaws sheath diameter compatible with bronchoscope 1 pcs Bacterial filter 4 pcs 20 4 Warranty and Service 24 months from the moment of installation ii Conditions Maximum response time at beneficiary site 72 hours Training for at least 2 medical personnel on site at beneficiary location in Russian language Training for at least 2 technical personnel on site at beneficiar 20 5 Incidental Services OE a a peee on siteatb aes location in Russian language Installation and commissioning User manual in English or translated into Russian language Item Quantity _ ITEM 21 ECG 1 21 1 Standard requirements 1 Compliant to EU Medical devices Directives CE Mark 2 Compliant to IEC 60601 and amendments for Medical electrical equipment ISO 9001 certified companies 21 2
5. Storing atleast 100 records at least 10 seconds long strips Defibrillation protection Pacemaker detection Built in accumulator At least 2 hours autonomy The accumulator is re charging automatically Thermal paper rolls or other system 20 pcs Thermal paper rolls or other system 20 pcs ECG cables and electrode reusable for adults and disposable for 150 patients infant and small children 21 4 Warranty and Service Conditions 24 months from the moment of installation Maximum response time at beneficiary site 72 hours 21 5 Incidental Services Training for at least 2 medical personnel on site at beneficiary location in Russian language Training for at least 2 technical personnel on site at beneficiary location in Russian language Installation and commissioning User manual in English or translated into Russian language Item Quantity ITEM 22 HOT AIR STERILIZIATION 6 22 1 Standard requirements 1 Compliant to EU Medical devices Directives CE Mark 2 Compliant to IEC 60601 and amendments for Medical electrical equipment ISO 9001 certified companies 22 2 Characteristics Hot air sterilizer with chamber volume min 50 liters Chamber made from stainless steel Door with lateral opening with handling for safety against the accidental opening Selected programs for sterilization heating or drying of mater
6. Item Quantity _ ITEM 3 ANESTHESI A MACHINE D 1 3 2 Basic Structure Russian language Capability of fully automatic compliance and leak test Display of real time curves Display of airway pressure Display of volatile anesthetic agent concentration Display of Inspiratory and expiratory flow Display of minute volume Capability to register and show on display or printed list time and event triggered list please specify the available events triggered Measuring parameters of the ventilation and gas Pressure measurement Tidal Volume Minute volume Measuring of gas concentrations O2 measurement CO concentration Anesthetic gas measurement N O measurement Measurement of volatile anesthetic agents Automatic recognition of volatile anesthetic agent and mixtures of different volatile anesthetic agents Measurement quantity of two volatile anesthetic agents in gas mixture Alarms and limit values for ventilation parameters and gas monitoring Alphanumerical plaintext display of measuring parameters and set alarm limit values Audible and visual alarm priority within the alarm levels List of all active alarms in order of priority Configurable basic setting of alarm limits for each specific mode of ventilation Requirements for Bronchus aspirator Bronchus aspirator with integrated ej
7. 11 7 2 Basic Structure Portable suction unit Suitable for adults and neonates use Vacuum range between around 20 and 300 mmHg adjustable from a button Vacuum indicator Fast aspiration at around 10 30 lpm flow Sealed water resistant unit Automatic float shut off to prevent overflow into the unit Preferable Integrate bacterial filter Control panel tilted for easy viewing of the controls Main body made of durable and resistant material LED indication for bad battery Indication for battery charge status Remote internal AC charger for battery Charging circuit capable of running on low battery Power supply 220VAC 50Hz Rechargeable battery Battery rechargeable Long operating time at full vacuum uninterrupted min 40 60 min Low charge time max 6 8 hours 7 3 Accessories and consumables Reusable collecting container min 1000 ml 1 pcs Bacterial filter preferable reusable Please specify type of filter For single use filters provide 50 pcs 2 auto clavable silicon suction tubes 7 4 Warranty and Service Conditions Period 24 months from the moment of installation of the equipment Battery warranty at least 6 months Maximum response time 72 hours 7 5 Incidental Services Training for at least 2 medical personnel on site at beneficiary location in Russian language Training for at lea
8. Automatically display of battery status fuel gage while operating on battery power Automatic internal recharge when the monitor is plugged into an AC power supply Low battery audio and visual alarm Capable of recording all numeric and waveform information displayed on the screen for min 24 hours 5 3 Accessories Extra battery 1 piece ECG cables with 3 leads 2 pieces Cuff set reusable all dimensions newborn pediatric and adult Iset SpO gt 2 multisensor sensor pediatric adult with cable with approximately 5 foots 2 pcs SpO gt 2 sensor newborn with cable with approximately 8 foots consumables for 500 tests ECG electrodes newborn infant 200 pcs ECG electrodes pediatric adult 500 pcs Blood pressure cable 3 ft 2 pcs Temperature cable 3ft 2 pcs Temperature probe covers 500 pcs Blood pressure cuffs Sizes 1 2 3 4 5 6 pcs each 5 4 Warranty and Service Conditions 24 months from the moment of installation Maximum response time at beneficiary site 72 hours 5 5 Incidental Services Training for at least 2 medical personnel on site at beneficiary location in Russian language Training for at least 2 technical personnel on site at beneficiary location in Russian language Installation and commissioning User manual in English or translated into Russian language Item Quantity ITEM 6 PORTABLE PULSE O
9. Technical Characteristics Equipment for recording heart electrical activity 12 channel ECG with 12 leads Minimum 6 Number of traces to be displayed simultaneously Preferable touch scree LCD or LED Resolution at least 640 480 pixels Possibility of introducing for each patient the following data name date of birth date of recording weight age diagnosis and comments 12 leads ECG limb derivations Il Ill aVL aVF aVR precordial derivations V1 V2 V3 V4 V5 V6 Manual selection for any 12 lead Graphic LCD viewing area for life 3 channel display with patient information Indicator for faulty leads Digital filters for all possible interferences Please specify which types of filters Calibration 1mV test Sensitivity and Frequency response test Working frequency 0 67 150 Hz Band Filters muscle low frequency high frequency 50 Hz Sensitivity adjustment 5 10 and 20 mm mvV Gain adjustment x x 1 and x 2 Full screen preview to determine quality of ECG ECG interpretation with interpretation statements Low battery check and alarm Optional indication of bradycardia and tachycardia Printer Printing speed 25 mm s or 50 mm s Recording paper thermal A4 size 27 Item Quantity ITEM 21 ECG 1 21 3 Accessories and Consumables Printout of patient ECG with patient information
10. Conditions 24 months from the moment of installation Maximum response time at beneficiary site 48 hours 12 5 Incidental Services Training for at least 2 medical personnel on site at beneficiary location in Russian language Training for at least 2 technical personnel on site at beneficiary location in Russian language Installation User manual in English or translated into Russian language Item Quantity ITEM 13 OXYGEN HOO D 6 1 Compliant to EU Medical devices Directives CE Mark 2 Compliant to IEC 60601 and amendments for Medical electrical 13 1 Standard requirements equipment ISO 9001 certified companies Transparent oxygen hood for neonates with head waist aperture 13 2 Basic Structure 2 two sliding doors Silicone flap in the head waist aperture 13 3 Technical Suitable for neonates and infants 20 Item Quantity ITEM 13 OXYGEN HOOD 6 Characteristics Fits into all incubators and open care beds tables Allows consistent and even oxygen flow to the baby Manufactured from food grade polycarbonate Easy access on each side for I V lines oxygen analyzers or ECG wires Big clear sliding doors Raked head aperture Soft material in the aperture for maintaining oxygen and humidity Interior gas deflection system for preventing baby s cooling Possibility to measure the interior temperature Period
11. infant pediatric and adult ventilation Standby holder for breathing bag and Y piece Accessories needed for neonates infant pediatric and adult ventilation Breathing system suitable for spontaneous breathing Manual ventilation Volume controlled ventilation Pressure controlled ventilation Synchronized volume controlled ventilation Pressure support of synchronized pressure and volume controlled ventilation Pressure support mode with apnea ventilation Requirements for vaporizers connection Connections for vaporizers integrated in the basic unit double plug in system Closes automatically when vaporizer is removed Possibility to change between two volatile anesthetic agents without being necessary to replace the vaporizer Safety device interlock to ensure only one vaporizer operation Basic unit equipped with isoflurane and sevoflurane vaporizers Requirements for fresh gas delivery Integrated in the basic unit with possibility for Delivery of fresh gas for gas mixtures of O2 and N20 or O and Air is controlled Fresh gas adjustments with mechanical pneumatical or electronic settings Electronic carrier gas switch over between air and N20 Regulator to ensure an oxygen concentration in the nitrous oxide oxygen mix Capability of delivery 21 vol O2 when using medical air as gas carrier Electronic regulator to ensure at least 25 vol or 200
12. adjust the amplitude of the signal Possibility to choose the lead to be displayed Cable with 3 wires l Il Ill aVL aVR aVF Optional Cable with 10 wires Il Ill aVL aVR aVF Optional V1 V2 V3 V4 V5 V6 Respiratory rate Limits low limit at least O breaths per minute high limit at least 150 breaths per minute Oxygen saturation of hemoglobin O saturation low limit at least 30 high limit at least 100 Pulse rate low limit at least 30 bpm beats per minute to high limit at least 250 bpm Adjustable averaging time Signal quality meter on screen Blood pressure Oscilometry measurement Measures and displays systolic and diastolic blood pressures Automatically adjustable intervals of approximately 1 min 8hours Discriminates between pressure signals and patient movement Display current and previous pressure values systolic diastolic Automatically zeroes prior to each reading Blood pressure cable and cuffs for all age mentioned above Temperature Measurement low limit at least 28 C high limit at least 42 C Cable for temperature monitoring to be connected with probe and temperature probe or probe incorporated in the cable assembly Mandatory rectal and skin probe 12 Item Quantity ITEM 5 INTENSIVE CARE MONITOR 4 Other condition Power requirements 220 VAC 50 Hz Autonomy with battery at least 2 hours
13. ml min of oxygen in the nitrous oxide oxygen mix when delivery gas flow below min 1 L min N20 is automatically cut in case of O2 shortage In case of O shortage switch over to 100 air is done automatically at constant fresh gas flow Optional Capability of self resetting O flush with a capacity of max 35L min for operation from central supply station with a nominal supply pressure of max 5 bar O safety flow adjustable min range 0 to 10 L min running through vaporizer Item _ ae Quantity ITEM 3 ANESTHESIA MACHINE 1 3 2 Basic Structure The central Control panel will display all instructions in English or Russian language Basic settings of fresh gas quantity and composition can be configured Possibility for patient specific presetting of fresh gas quantity and fresh gas composition in standby mode Audible and visual alarms in case of air and NO shortage Audible alarms cannot be silenced in case of O shortage No possibility to increase pressure in vaporizer when O flush is activated Requirements for the ventilator NeogasneededtodrivetheventHator Ventilation electrically driven Suitable for neonates to adults without changing any ventilator parts The system should preferably be able to measure volatile agent and fresh gas consumption per case Suitable for time cycled and volume controlled ventilation Suitable for pressure controll
14. of the supplies fail The offered unit shall have a circuit compliance compensation approximately 0 0 to 7 5 ml cmH20 and must be automatically measured Item __ Quantity _ ITEM 2 PEDIATRIC INF ANT VENTILATOR 1 2 2 General Characteristic Monitoring and displayed parameters LCD or LED display The central Control panel will display all instructions in English or Russian language Parameters Approximate ranges are indicated slight variations will be accepted Respiratory rate per minute Pediatric Infant 1 to 120 b min Inspiratory Flow Pediatric Infant 0 4 to 100 L min Inspiratory Time Pediatric Infant 0 1 to 3 seconds Time expiratory 0 2 20 s Pressure Support Pediatric Infant 0 to 50 cmH20 Pressure Limit Pediatric Infant 0 to 70 cmH2O0 PEEP CPAP Pediatric Infant 0 to 30 cmH2O0 LE 1 4 to 4 1 Flow Trigger Pediatric Infant 0 1 to 20 L min Oxygen Concentration from 21 to 100 Leak Compensation Pediatric Infant Up to 8 L min Breathing Selectable up to 1 to 150bpm Alarms Both audible and visual alarms shall be available on the following ventilator amp patient parameters Patient disconnect Oxygen concentration variation Over and under patient pressure Over and under patient volume High continues pressure Inverse I E ratio
15. purity class or ISO 8573 Replacement of internal filters should be performed without removing the compressor 10 Item Quantity ITEM 4 COMPRESSOR FOR MEDICAL AIR 4 Provide at least 5 sets of air filters Power Supply 220 VAC 50 Hz 4 3 4 4 Warranty and Service Conditions Incidental Services 24 months from the moment of installation Maximum response time at beneficiary site 48 hours Training for at least 2 medical personnel on site at beneficiary location in Russian language Training for at least 2 technical personnel on site at beneficiary location in Russian language Installation User manual in English or translated into Russian language _Item_ Quantity ITEM 5 INTENSIVE CARE MONITOR 4 5 1 5 2 Standard requirements Characteristics CE Mark ISO 9001 2000 certified companies Color Screen LCD or LED monitor Minimum screen resolution 800 x 600 pixels Screen dimensions Color screen with at least 300 mm diagonal Speed of recording 6 25 12 5 or 25 mm second Visible in the same time on the screen One lead ECG wave form and heart rate value respiration wave form and respiratory rate p02 waveform and value non invasive blood pressure values Systolic diastolic and mean and temperature value Central Control panel will display all instructions in English or Russian language Measu
16. 2 Compliant to IEC 60601 and amendments for Medical electrical equipment ISO 9001 certified companies Optical lighting system reflector for optimum illumination of the operation light field cool white light free from deep shadows Adjustable height and articulated arm LED lamp technology Light field size gt 120mm Technical Low power consumption max 150VA 17 2 Characteristics On off switch Lamp life min 20000 hours Please specify Light characteristics Lux approx 15 000 at 1m Color temperature approx 4 300 K Mobile stand with 5 castors at least 2 with breaks Lamp must be water proof and fluid resistance for cleaning 17 1 Standard requirements purposes 17 3 Accessories Spare lamp 1 pcs if applicable Warranty and Service 24 months from the moment of installation 17 4 sa z gt Conditions Maximum response time at beneficiary site 72 hours Training for at least 2 medical personnel on site at beneficiary location in Russian language 17 5 incidental Services Training for at least 2 technical personnel on site at beneficiary location in Russian language Installation User manual in English or translated into Russian language Item Quantity ITEM 18 INSTRUMENTS TABLE 8 1 Compliant to EU Medical devices Directives CE Mark 2 Compliant to IEC 60601 and amendments for Medical electrical equipment ISO 9001 certified companies Stainless stee
17. 24 months from the moment of installation of the Warranty and Service 13 4 bes equipment Conditions n Maximum response time 72 hours Training for at least 2 medical personnel on site at beneficiary location in Russian language 13 5 iedental Services oe for at least 2 technical personnel on site at beneficiary ocation in Russian language Installation User manual in English or translated into Russian language Item Quantity ITEM 14 FETAL HEART DETECTOR 4 1 Compliant to EU Medical devices Directives CE Mark 2 Compliant to IEC 60601 and amendments for Medical electrical 14 1 Standard requirements equipment ISO 9001 certified companies Compact lightweight and portable device complete with carrying case rechargeable batteries gel and optional head set if any 14 2 Characteristics Specify measurement method Audible and visible heart beat indication Fetal Heart rate calculation and display FHR range 0 210 bpm Large Display Weight lt 700 g Indicate displayed parameters Speaker yes no Power Requirements VAC 220 50Hz Plug Type F CONTROLS 14 3 Technical Requirements ON OFF Volume Audio mute Calibration Easy to clean Waterproof fluid resistant Battery operation Rechargeable standard batteries 21 Item Quantity
18. Annex 1 Technical Specifications of required equipment for Slobozia Grigoriopol Rybnitsa Maternity Unit and Pediatric ICU Tiraspol Item Quantity ITEM 1 TABLE FOR WARMING AND NEWBORN 2 RESUSCITATION 1 Compliant to EU Medical devices Directives CE Mark 2 Compliant to IEC 60601 and amendments for Medical electrical equipment ISO 9001 certified companies Height adjustable table Resuscitation Radiant Warmer consisting of Heat source Bassinet and mattress Mounting column with fixed height System for resuscitation Suction devices for cleaning of the neonatal airways Storage compartments Front drawers for storage X Ray tray Rails for accessories Patient skin probe a Heat source controller and functions Mean irradiance at mattress level minimum 10 mW cm2 The central Control panel will display all instructions in English or Russian language Control panel located centrally at eye level Microprocessor controller with control modes Manual mode in minimum 5 10 increments from 0 to 100 Automatic pre warm mode Servo baby mode Servo control temperature range between approximate 35 37 C Display temperature range between 30 and 42 C Examination lamp of minimum 50 W and minimum 1 000 Lux Apgar timer integrated Patient skin probe reusable 2 pieces b Bassinet and mattress Mattress area minimum 3 000 cm Mechanical or Hydraulic tilt mechanism for the bassinet at least 10 minimum Mattress th
19. C 60601 and amendments for Medical electrical equipment ISO 9001 certified companies 26 2 Technical Characteristics Standard refrigerator Capacity 50 150 Built in single door Temperature 0 4 C Low power consumption Electrical power connector should be standard type Power supply 220V AC 50 Hz 26 3 Warranty and Service Conditions Period 24 months from the moment of installation of the equipment Maximum response time 72 hours 26 4 Incidental Services Training for at least 2 medical personnel on site at beneficiary location in Russian language Training for at least 2 technical personnel on site at beneficiary location in Russian language Installation User manual in Russian language ITEM 27 STANDARD HO MATTRESS SPITAL BED WITH 27 1 Standard requirements 1 Compliant to EU Medical devices Directives CE Mark 2 Compliant to IEC 60601 and amendments for Medical electrical equipment 31 Item Quantity ITEM 27 STANDARD HOSPITAL BED WITH MATTRESS ISO 9001 certified companies 27 2 Bed mattress cover antimicrobial fire retardant fluid proof 27 3 Technical Characteristics Warranty and Service Conditions 20 Standard hospital bed Size approximately 2000 2030 900 910 500 cm Steel Iron frame painted in electrostatic field with powder paint Stainless steel h
20. TEM 12 RESUSCITATIO N BALOON 5 12 1 Standard requirements CE Mark ISO 9001 2000 certified companies 12 2 Technical Characteristics Silicone resuscitation balloons for providing fast simple and effective ventilation to non breathing patients self inflating bags in three sizes adult pediatric pre term Adult model over 25 kg Pediatric model 2 5 25 kg Preterm model under 2 5 kg Adult bag with a minimum of 2 different size masks patient valve and supplementary oxygen admission system with reservoir and valve Pediatric bag with a minimum of 3 different size masks patient pop off valve and supplementary oxygen admission system with reservoir and valve Preterm bag with a minimum of 2 different size masks patient pop off valve and supplementary oxygen admission system with reservoir and valve Standard connections between the different components Pop off pressure release valve Valve system respond to the rescuer and the patient Possibilities to adapt to a pressure manometer Audible overpressure alert Extension tube for patient connection Operating temperature range min 10 C to 50 C Storage temperature range min 40 C to 60 C 12 3 Accessories Pediatric Neonatal mask 3 different size 2 pcs of each size Pre term mask 2 different size 2 pcs of each size Adult mask 2 different size 2 pcs 12 4 Warranty and Service
21. XYMETER 6 6 1 Standard requirements 1 Compliant to EU Medical devices Directives CE Mark 2 Compliant to IEC 60601 and amendments for Medical electrical equipment ISO 9001 certified companies 6 2 Basic Structure Monitor for SpO2 and pulse rate Portable pulse oxymeter Universal connection for sensors 6 3 Technical Characteristics a Monitor Removable handheld display for SoO2 and pulse rate ensures continuous monitoring Oximetry technology clinically proven to work under motion and poor perfusion conditions 13 Item Quantity ITEM 6 PORTABLE PULSE OXYMETER 6 Patients perfusion level display Sensor signal quality indicator to ensure best sensor position placement Full patient alarms including high and low saturation and pulse rate Downloadable min 24 hour memory at 2 seconds resolution with the ability to review trend data on screen Fast time to initial reading after sensor placement Probe off detection system to alert user of probe displacement High sensitivity mode for improved performance on poorly perfused patients LCD waveform display User selectable averaging time SpO2 range 30 100 Pulse rate approximately 0 250 bpm Perfusion optional 0 02 10 Saturation accuracy in motion for infant 3 digits 8 hour battery life for the portable display Configurable display including big numb
22. ary location in Russian language raining for at 2 technical personnel on si neficiar 23 5 incidental Services Training for at least 2 technical personnel on site at beneficiary location in Russian language Installation User manual in English or translated into Russian language ITEM 24 GLUCOMETER 3 1 Compliant to EU Medical devices Directives CE Mark 2 Compliant to IEC 60601 and amendments for Medical electrical 24 1 Standard requirements Sauipnment ISO 9001 certified companies Whole blood measurements Technical Measurement range min 10 700 mg dl 24 2 Characteristics No light influence Compensated with temperature influence Serial imprecision max 4 24 3 Consumables Strips for 500 of tests open market not limited to one company Period 24 months from the moment of installation of the Warranty and Service 24 4 vs equipment Conditions Maximum response time 72 hours Training for at least 2 medical personnel on site at beneficiary location in Russian language 24 5 Incidental Services Training for at least 2 technical personnel on site at beneficiary location in Russian language Installation User manual in English or translated into Russian language ITEM 25 SPHYNGOMANOMETER 12 25 1 Standard requirements 1 Compliant to EU Medical devices Directives CE Mark 2 Compliant to IEC 60601 and amendments for Medical electrical equipm
23. e mode 1 0 Switch off temperature of the heater when there is inadmissible overheating of the mattress surface Heating time not more than 20min Alarms Alarm signaling OVERHEATING Main mode at temperature within C 38 0 0 4 Additional mode at temperature within C 40 0 0 4 Technical Other malfunctions are indicated by alarms sical Characteristics Mattress Overall dimensions of the mattress mm not more than Height 20 Width 600 Length 750 Mattress cover antimicrobial fire retardant fluid proof Control unit Display with LED Built in handle ON OFF Display the temperature Alarm ON OFF 19 3 Warranty and Service 24 months from the moment of installation i Conditions Maximum response time at beneficiary site 72 hours Training for at least 2 medical personnel on site at beneficiary location in Russian language 19 4 Incidental Services Training for at least 2 technical personnel on site at beneficiary location in Russian language Installation User manual in English or translated into Russian language 25 Item Quantity _ ITEM 20 BRONHOSCO P D 1 20 1 Standard requirements 1 Compliant to EU Medical devices Directives CE Mark 2 Compliant to IEC 60601 and amendments for Medical electrical equipment ISO 9001 certified companies 20 2 Characteristics Medical device diagnosis of lung and airways and remove foreign bodies in the airway Pediatric rig
24. ead and foot ends with vertical bars Mounted on protective stumps Weight user max 2180kg 2 section easy adjustable with handle back section lifting angle 75 80 grade foot section lifting angle 45 grade Mattress compliant with bad size Period 24 months from the moment of installation of the equipment Maximum response time 72 hours 27 4 Incidental Services Training for at least 2 medical personnel on site at beneficiary location in Russian language Training for at least 2 technical personnel on site at beneficiary location in Russian language Installation User manual in Russian language Item Quantity ITEM 28 HOSPITAL BEDSIDE CABINET 20 28 1 Standard requirements 1 Compliant to EU Medical devices Directives CE Mark 2 Compliant to IEC 60601 and amendments for Medical electrical equipment ISO 9001 certified companies 28 2 Technical Characteristics Dimensions approximately width 400mm depth 500mm height 650mm 1 drawer and 1 storage cabinet Build in metal painted in electrostatic field Color withe 28 3 Warranty and Service Conditions Period 24 months from the moment of installation of the equipment Maximum response time 72 hours 28 4 Incidental Services Training for at least 2 medical personnel on site at beneficiary location in Russian langua
25. ector bracket for secretion jars can be removed from basic unit Secretion jar package includes all necessary accessories Integrated manometer for vacuum display Requirements for monitoring the vital parameters Device used for continuous monitoring of vital parameters for neonates infants pediatric and adult patients The device will monitor heart rate ECG with minimum 3 leads saturation in oxygen of hemoglobin noninvasive blood pressure and temperature Possibility for visualizing the parameters on screen Alarms for each parameters mentioned above Connectors for medical gases All connectors must be type compatible to EN ISO 7396 DIN 13260 2 Requirements for uninterruptible power supply 9 Item __ Quantity _ ITEM 3 ANESTHESIA M ACHINE 1 3 3 3 4 Accessories and Consumables Warranty and Service Conditions Integrated in the basic unit Fully automatic switching to UPS in case of mains failure Autonomy for approximately 60 min Unit shall be equipped with all necessary accessories min the following pressure reducers connecting hoses reusable breathing hoses vaporizer sensors filters bronchus aspirator etc ready to work for 30neonates 75 infant 400 children 100 children over 10 years Will be specified all items included in offer Device used for continuous monitoring of vital parameters for the same number of pati
26. ed ventilation Possibility of manual ventilation even if external and internal power supply failure Capability to check system compliance in standby after replacing patient hoses Possibility to configure all basic settings for anesthetic ventilation for each specific ventilation mode Possibility of patient specific pre settings for ventilation parameters in standby mode and prior of changing ventilation mode Adjustment ranges of ventilation parameters in volume mode approximate ranges slight variations will be accepted Tidal volume 20ml 1500ml PEEP 0 20 mmHg Inspiratory pause 0 60 s Ventilation frequency 5 60 bpm 1 Eratio 1 3 to 3 1 Tinsp 0 5 6s Pressure limitation P max 5 70 cmH20 Preferably to have decelerating flow control Adjustable flow trigger for synchronized volume and pressure controlled ventilation Flow trigger min range 1 0 15 l min Ventilation parameters and alarm limits retained and presetting determined on the basis of measured variables when switching between ventilation modes Presetting of ventilation parameters and alarm limits are weight based Requirements for ventilation and gas monitoring Ventilation and gas monitoring integrated in anesthesia unit Preferable operating concept screen based for all operational functions The central Control panel will display all instructions in English or 8
27. edical devices Directives CE Mark 2 Compliant to IEC 60601 and amendments for Medical electrical equipment ISO 9001 certified companies 23 2 Technical Characteristics Equipment for broncho pulmonary pathologies asthma pneumopathies cystic fibrosis Dedicated for all medicines bronchodilators antibiotics corticoids and mucolytic Running mode the aerosol is produced continuous Autoclavable up to 134 C Preferable reusable accessories tubes masks Nebulizer Container capacity approximately 5 ml Equipped with tube with length approximately 1m Multi position mask for adult and pediatric Equipped with mouth end piece and flask for dosage Compressor Oil free Maintenance free Small dimensions portable device Low weight portable device Low noise device approximate 30 dB Pressure adjusted to 0 5 bar Possibility to be fed by an oxygen central source compressor flow in charge with minimum 5l min 23 3 Accessories and Consumables Mouth end piece 5pcs Nose plug 2pcs Nose piece 2pcs Masks adult 2pcs Masks pediatric 5pcs 23 4 Warranty and Service Period 24 months from the moment of installation of the 29 ITEM 23 NEBULIZER FOR DRUGS 5 Conditions equipment Maximum response time 72 hours Training for at least 2 medical personnel on site at benefici
28. ent ISO 9001 certified companies 25 2 Characteristics Digital Blood Pressure Monitor Sphygmomanometer Upper Arm for neonates infant children and adults Four mode for adult pediatric infant and neonatal selectable Measures systolic diastolic pressure and pulse Fully automatic one touch operation Automatic inflation and deflation High resolution large LCD display panel shows readings of blood pressure pulse rate Optional 50 memories 30 ITEM 25 SPHYNGOMANOMETER TTH Cuff size Neonate cuff size Infant cuff size Pediatric cuff size Adult cuff size AA Size Alkaline Battery and AC DC Adapter 25 3 Accessories All cuff size neonates infant children and adult 1 pcs for each size Other accessories and consumables if needed 25 4 Warranty and Service Conditions 24 months from the moment of installation Maximum response time at beneficiary site 48 hours 25 5 Incidental Services Training for at least 2 medical personnel on site at beneficiary location in Russian language Training for at least 2 technical personnel on site at beneficiary location in Russian language Installation User manual in English or translated into Russian language ITEM 26 REFRIGERATEUR _ 6 26 1 Standard requirements 1 Compliant to EU Medical devices Directives CE Mark 2 Compliant to IE
29. ent neonates infants pediatric and adult patients The device will monitor heart rate ECG with minimum 3 leads saturation in oxygen of hemoglobin noninvasive blood pressure and temperature Reusable cables for ECG SpO2 temperature probe cuff for NIB for all size disposable device for ECG S pO2 temperature Will be specified all items included in offer 24 months from the moment of installation Maximum response time at beneficiary site 72 hours 3 5 Incidental Services Training for at least 2 medical personnel on site at beneficiary location in Russian language Training for at least 2 technical personnel on site at beneficiary location in Russian language Installation User manual in English or translated into Russian language Item Quantity ITEM 4 COMPRESSOR FOR MEDICAL AIR 4 4 1 Standard requirements 1 Compliant to EU Medical devices Directives CE Mark 2 Compliant to IEC 60601 and amendments for Medical electrical equipment ISO 9001 certified companies 4 2 Characteristics Compatible with the resuscitation module from resuscitation table ventilator and CPAP Stand alone medical air compressor Air Flow gt 40 L min Noise lt 60 dBA adjustable pressure 2 4 bar Snap fit with the resuscitation module from resuscitation table to provide medical air Air quality should comply with European Pharmacopoeia compressed air
30. ere is a risk of occlusion or a possible leak in the infusion line Occlusion in preselected mode min three pre selectable pressure alarm limits occlusion Infusion continuity protection Automatic internal battery operation during patient transfer AC power failure Infusion data memorization flow rate bolus rate volume volume limit KVO rate Event logging Electronic pressure management Fixing accessory for IV pole Infusion alarm Pre alarm end of infusion 17 Item Quantity ITEM 9 SYRINGE INFUSION PUMP 11 200 connectors from the syringe to the patient for each syringe Pre alarm volume limit Occlusion alarm Alarm for the end of infusion Alarm for volume limit Technical alarms Disengaged driving mechanism alarm Low battery pre alarm Discharged battery alarm Battery capacity display Unconfirmed programming Main malfunction alarms Syringe position control Syringe barrel clasp check Plunger head detection Occlusion pressure Locking syringe Fixing accessory Power 220 V AC 50 Hz Battery life min 3h charge infusion pump sii Consumables 200 syringe 20 ml for each syringe infusion pump 200 syringe 50 ml for each syringe infusion pump 9 5 Warranty and Service 24 months from the moment of installation ai Conditions Maxi
31. ers option On screen alarm values Alimentation with power cord for 220 V b Sensors Sensors with recessed photo detector to reduce ambient light and electromagnetic interference Extended adhesive sensor life by use of rejuvenatable adhesive Low weight adhesive sensors Single patient use with proven clinical lifetime of minimum 8 days Adhesive sensors manufactured from durable moisture resistant material Interconnection cable 1 pcs 1 SpO2 sensor reusable for adults finger 6 4 E 1 SpO2 sensor reusable for children 100 single patient use SpO2 sensors for neonates 30 single patient use SpO2 sensors for neonates lower than 2 Kg 6 5 Warranty and Service 24 months from the moment of installation E Conditions Maximum response time at beneficiary site 72 hours Training for at least 2 medical personnel on site at beneficiary location in Russian language 6 6 Incidental Services Training for at least 2 technical personnel on site at beneficiary location in Russian language Installation and commissioning User manual in English or translated into Russian language Item Quantity ITEM 7 SUCTION UNIT 7 1 Standard requirements 11 1 Compliant to EU Medical devices Directives CE Mark 2 Compliant to IEC 60601 and amendments for Medical electrical equipment ISO 9001 certified companies 14 Item Quantity ITEM 7 SUCTION UNIT
32. ge Training for at least 2 technical personnel on site at beneficiary location in Russian language Installation User manual in Russian language 32 ITEM 29 DIGITAL WEGHING SCALE FOR NEONATES 1 Compliant to EU Medical devices Directives CE Mark 2 Compliant to IEC 60601 and amendments for Medical electrical equipment ISO 9001 certified companies Digital Baby Scale for weighing neonates 29 1 Standard requirements Technical Weigh up to 500 gr to 10 kg 20 kg 29 2 Characteristics Accuracy 3 ae Auto zero and auto off functions Large LCD display Operates on 120V 230V and rechargeable battery Period 24 months from the moment of installation of the Warranty and Service 29 3 ae equipment Conditions Maximum response time 72 hours Training for at least 2 medical personnel on site at beneficiary location in Russian language 29 4 incidental Services Training for at least 2 technical personnel on site at beneficiary location in Russian language Installation User manual in Russian language 33
33. ials Min 3 working programs Ventilation air system in spiral way to assure the temperature in chamber Control panel and LED LCD display Overheating protection system Display of temperature and time Accuracy 3 C Indication of the already done and current sterilization phase RS 232 interface for printer or PC communication Optional Acoustic alarm for overtake of programed temperature or other error Precise control of the sterilization cycle parameters with microprocessor Delayed heating start and stop function Temperature sensor Chrome plated trays 2 pcs Working temperature at least from 10 C above ambient to 250 C Time required to reach 250 C max 60 min 28 Item Quantity ITEM 22 HOT AIR STERILIZIATION 6 Weight max 75 kg Power Power supply 220 VAC 50 Hz 22 3 Warranty and Service Conditions 24 months from the moment of installation Maximum response time at beneficiary site 48 hours 22 4 Incidental Services Training for at least 2 medical personnel on site at beneficiary location in Russian language Training for at least 2 technical personnel on site at beneficiary location in Russian language Installation User manual in English or translated into Russian language Item Quantity ITEM 23 NEBULIZER FOR DRUGS 5 23 1 Standard requirements 1 Compliant to EU M
34. ickness minimum 2 cm Ray cassette tray to fit under mattress 1 piece Four foldable bassinet walls Ventilator tube supports c Mounting column Fixed height column on mobile castors 1 1 Standard requirements 1 2 Basic Structure 1 3 Accessories Item Quantity ITEM 1 TABLE FOR WARMING AND NEWBORN RESUSCITATION 2 Built in rails for accessories 2 pieces d Resuscitation module Wall supply pressure 3 6 bar Cylinder for oxygean and cylinder for compressed air pressure Adjustable positive end expiratory pressure Pressure PEEP 0 25 cm H20 Gas bleed 0 15 L min Precision blender 21 100 O2 3 Mask for resuscitation size 0 1 and 2 two pics for each size Circuits T Pieces e Storage compartments Front storage drawers 2 pieces 1 3 Accessories f Alarms Audio alarms Controller heating alarms Check patient 15 minutes in Manual Mode Baby temperature 1 C from Set Point High temperature Skin Temp 39 0 C 0 2 C Probe Short or open circuit No probe System fail Indicates System Fail Power fail AC Power Interruption Alarm silence reset intervals Check patient Resets clock for 15 minutes manual mode Baby temperature 10 minutes High temperature 2 minutes Procedural silence Presilences baby temp a
35. id bronchoscope for pediatric cases consisting of Rubber telescope guide for telescopes Telescope angle of view 0 diameter between 2 7 2 9 mm Telescope angle of view 0 diameter between 2 8 3 mm Bronchoscope tubes and foreign body alligator extraction forceps Bronchoscope tubes for neonates and foreign body alligator extraction forceps suitable for the bronchoscope Size between 3 3 4 3 mm Length between 180 200 mm Bronchoscope tubes for infants and foreign body alligator extraction forceps suitable for the bronchoscope Size between 4 2 5 1 mm Length between 250 265mm Bronchoscope tubes for small children and foreign body alligator extraction forceps suitable for the bronchoscope Size between 4 9 5 5 mm Length between 290 310 mm Bronchoscope tubes for children under 10 years and foreign body alligator extraction forceps suitable for the bronchoscope Size between 5 9 6 9 mm Length between 290 310mm Bronchoscope tubes for children over 10 years and foreign body alligator extraction forceps suitable for the bronchoscope Size between 7 7 9 mm Length between 390 405 mm Light deflector for the described tubes Suction pump Instrument guide for suction catheter Rigid suction tubes of approximate 35 cm length and 3mm diameter with rubber tip straight and curved Adaptor for respirator
36. klight Microprocessor controlled Electronic blender built in Dual flow system for independent setting of in and expiratory flow Proximal flow sensor reusable autoclavable Inlet pressures from approximately 1 5 to 6 bar Capable for transports with min 60 minutes independent from medical air hospital system The ventilator shall provide the following ventilation modes both invasively and non invasively for Infant and Pediatric ventilation Assist Control in Volume and Pressure mode Time Cycled mode Synchronized Intermittent Mandatory Ventilation in volume and pressure mode Continuous Positive Airway Pressure with Pressure supported ventilation Spontaneous Manual Breath 2 2 General Characteristic Inspiration Hold Expiration Hold Back Up Apnea Ventilation in all modes The ventilator shall provide the following breath types for Pediatric and Infant modes Pressure Limited Volume Control Pressure Control with Volume target Pressure Ventilation with alternating baselines CPAP PEEP Timed Oxygenation 100 The offered unit shall have automatic switch over to a built in battery unit with a capacity to ensure full functionality of the unit for approximately 2 hours The offered unit shall have automatic switch over unit that will switch between the piped air and oxygen supply should one
37. l instrument table with shelf and four castors Rubber coated swivel castors at least two lockable Top and shelf strong enough to place heavy materials 18 1 Standard requirements Technical Dimensions approximately 18 2 Characteristics Width 120cm Height 90cm Depth 60cm Distance between shelves 50cm Warranty and Service 24 months from the moment of installation 18 3 Conditions Maximum response time at beneficiary site 72 hours Training for at least 2 medical personnel on site at beneficiary location in Russian language 18 4 Incidental Services Training for at least 2 technical personnel on site at beneficiary location in Russian language Installation 24 Item Quantity ITEM 18 INSTRUMENTS TABLE 8 User manual in English or translated into Russian language Item Quantity ITEM 19 NEONATAL MATTRESS HEATER 4 Standard CE Mark 19 1 Standard requirements S5 9901 2000 certified companies Equipment used for compensation of heat losses in neonates Complete unit microprocessor controlled functions for temperature set values etc Temperature setting range Main mode from 35 0 to 37 0 Additional mode from 37 1 to 39 0 Accuracy of temperature control 1 0 Maximum deviation of mattress surface temperature after switching to maximum temperatur
38. larm for 5 minutes Alerts Manual mode System alerts every 30 seconds gt 10 minutes for 15 minutes Apgar timer Alerts at 1 5 and 10 minutes g Physical properties Total height maximum 200 cm Mattress height at approximate 100 cm Weight maximum 100 Kg excluding accessories Power requirements 220 240 V 50 60 Hz 1 4 Warranty and Service 24 months from the moment of installation ii Conditions Maximum response time at beneficiary site 72 hours Training for at least 2 medical personnel on site at beneficiary location in Russian language 1 5 incidental Services Training for at least 2 technical personnel on site at beneficiary location in Russian language Installation User manual in English or translated into Russian language item S Quantity _ ITEM 2 PEDIATRIC INFANT VENTILATOR E 1 1 Compliant to EU Medical devices Directives CE Mark 2 Compliant to IEC 60601 and amendments for Medical electrical 2 1 Standard requirements quipment ISO 9001 certified companies This specification establishes the requirements for comprehensive ventilators with the latest technology to ventilate neonates infants and pediatric patients in Pediatric Intensive Care Units Be able to ventilate patients with a weight range of approximate 550g to 50Kg in all the ventilation modes General requirements identify requested functions Electro pneumatically controlled Built in graphic display with bac
39. mum response time at beneficiary site 48 hours Training for at least 2 medical personnel on site at beneficiary location in Russian language 9 6 incidental Services Training for at least 2 technical personnel on site at beneficiary location in Russian language Equipment assembly and installation on site User manual in English or translated into Russian language Item Quantity ITEM 10 PHOTOTHERAPY LAMP 3 1 Compliant to EU Medical devices Directives CE Mark 2 Compliant to IEC 60601 and amendments for Medical electrical 10 1 Standard requirements equipment ISO 9001 certified companies Phototherapy Unit 10 2 Basic Structure Mobile Stand a Phototherapy Unit Light characteristics LED lamp technology The possibility of adjusting the angle Technical Irradiance gt 20 uM cm2 10 3 Characteristics Bulbs tubes lamp characteristics Estimated life time gt 30000 h Specify the field size cm Diameter 18 Item Quantity ITEM 10 PHOTOTHERAPY LAMP 3 Low energy consumption Fault protection specify Maintenance free operation Easy light source replacement Eye protection 3 pics b Mobile Stand height adjustable between minimum 45 150 cm on3 4castors with locks 10 4 Consumables lamp 1 set 10 5 Warranty and Service 24 months from the moment of installation pag Conditi
40. ng labour and birth giving and for resting after the delivery in maternities of the first health care level Robust mobile delivery bed on castors with breaks Easy adjustable sections with handle gt 3 sections Height adjustable with handle 55 90 cm Trendlenburg and reverse Trendelenburg position easy adjustable with handle Shoulder and head rest Supplementary table completely recessable underneath the main Technical ped nae Surface covered with soft material washable resistant to chemicals Characteristics 16 2 Standard side rails to fix accessories Detachable adjustable height and width leg support Detachable adjustable height and width knee crutches with pads cover and strap Drain pan to collect physiologic and irrigating fluids Waste receptable with drainage hose Weight user 2180kg Auxiliary side arm board with pad swiveling Auxiliary height adjustable infusion pole Warranty and Service 24 months from the moment of installation 16 3 eae z Conditions Maximum response time at beneficiary site 72 hours Training for at least 2 medical personnel on site at beneficiary location in Russian language 16 4 Incidental Services ea for at least 2 technical personnel on site at beneficiary ocation in Russian language Installation User manual in English or translated into Russian language 23 item Quantity ITEM 17 MOBILE EXAMINATION LIGHT 6 1 Compliant to EU Medical devices Directives CE Mark
41. ons Maximum response time at beneficiary site 72 hours Training for at least 2 medical personnel on site at beneficiary location in Russian language 10 6 Incidental Services Me h for at least 2 technical personnel on site at beneficiary ocation in Russian language Installation User manual in English or translated into Russian language Item Quantity ITEM 11 LARINGOSCOPE 4 1 Compliant to EU Medical devices Directives CE Mark 2 Compliant to IEC 60601 and amendments for Medical electrical 11 1 Standard requirements equipment ISO 9001 certified companies Fiber optic laryngoscope Laryngoscope handle Rechargeable battery Knurled finish for sure grip Blade with fiber optic for cool light Halogen or xenon light for true tissue color Technical Long lasting illumination 11 2 Characteristics Removable fiber optic light pipe for instant replacement Fiber optic resistant about 1000 cycles of sterilizations Blades McIntosh type size 0 1 2 3 4 2 pcs Miller type size 00 0 1 2 3 2 pcs One piece stainless steel Charger for battery 220VAC 50 Hz Period 24 months from the moment of installation of the 11 3 Warranty and Service equipment Conditions Maximum response time 48 hours Training for at least 2 medical and technical personnel on site at 11 4 incidental Services beneficiary location in Russian language Installation User manual in English or translated into Russian language 19 Item Quantity _ I
42. raining for at least 2 medical personnel on site at beneficiary location in Russian language Training for at least 2 technical personnel on site at beneficiary location in Russian language Installation User manual in English or translated into Russian language Item Quantity ITEM 3 ANESTHESIA M ACHINE 1 3 1 Standard requirements 1 Compliant to EU Medical devices Directives CE Mark 2 Compliant to IEC 60601 and amendments for Medical electrical equipment ISO 9001 certified companies 3 2 Basic Structure Equipment for mechanical ventilation and anesthesia for neonatal pediatric and adults Compact mobile inhalation anesthesia machine with integrated ventilator and monitoring for pressure volume and oxygen System suitable for low flow and minimal flow anesthesia with re breathing systems optimized for neonatal to adult patients Anesthetic ventilator capability to switch from spontaneous breathing or manual to a mechanical one without the need of reconnection General requirements identify requested functions Basic unit including integrated gas supply consisting of central supply connections for O2 Air and N20 and integrated display of central supply pressures Integrated cabinet for covered and protected storage of reserve minimum 5 liter gas cylinders for O2 and N20 Automatic switch over to reserve gas cylinders in case of failure of central gas suppl
43. requency minimum 1 MHz Maximum constant intensity lt 15mW cm2 Heart rate fetal counting range between approximately 60 200 BPM Automatic detection of fetal movement Uterine Activity Uterine activity UA measurement with toco transducer Measurement range between 0 100 relative units 15 3 Accessories Manual or auto zero adjust FHR transducers 2 pieces with connection devices TOCO transducer 1 piece with connection devices Fetal monitor paper minimum 6 000 sheets Table top or roll stand support for monitor and transducers 1 piece 22 ___ item Quantity ITEM 15 CARDIOTOCOGRAPH 3 15 4 Warranty and Service 24 months from the moment of installation Conditions Maximum response time at beneficiary site 72 hours Training for at least 2 medical personnel on site at beneficiary location in Russian language Training for at least 2 technical personnel on site at beneficiary 15 5 Incidental Services location in Russian language Installation User manual in English or translated into Russian language Item Quantity ITEM 16 DELIVERY TABLE 4 1 Compliant to EU Medical devices Directives CE Mark 2 Compliant to IEC 60601 and amendments for Medical electrical 16 1 Standard requirements equipment ISO 9001 certified companies Non electric delivery bed to accommodate pregnant women in various comfortable positions duri
44. res heart rate beats per minute respirations breaths per minute SpO gt 2 percent blood pressure mmHg temperature C Structure Monitor Battery Patient cables in various lengths e g 3 amp 8 foots or similar range Cable for ECG electrodes Cable for blood pressure cuffs Cable for temperature sensor Cable for pulse oximeter sensors Control buttons On off Alarms standard Stand by Alarms System failure 11 _Item_ Quantity ITEM 5 INTENSIVE CAR E MONITOR 4 5 2 Characteristics Battery low Apnea Bradycardia Tachycardia Low respiratory rate High respiratory rate Saturation low Saturation high Blood pressure low systolic diastolic mean Blood pressure high systolic diastolic mean Temperature low Temperature high All alarms mentioned above are adjustable by the clinician at the bedside All alarms are audio and visual alarms The alarm tones can be regulated high to low tonality to alarm off at least Heart rate and EGK One derivation visible all the time on the screen There could be two channels visible optional Limits low limit at least 20 beats per minute high limit at least 300 beats per minute Derivations Il Ill aVL aVR aVF Optional V1 V2 V3 V4 V5 V6 Possibility to
45. st 2 technical personnel on site at beneficiary location in Russian language Installation and commissioning User manual in English or translated into Russian language Item Quantity ITEM 8 BASIC INCUBATOR 3 8 1 Standard requirements 1 Compliant to EU Medical devices Directives CE Mark 2 Compliant to IEC 60601 and amendments for Medical electrical equipment ISO 9001 certified companies 8 2 Basic Structure Incubator hood Temperature controller Standard humidity module Mobile stand a Incubator hood and mattress Double wall and other parts of incubator easily removable for 15 _ item _ Quantity ITEM 8 BASIC INCUBATOR 3 cleaning 8 3 8 3 Characteristics Characteristics At least two opposite doors for quick access Small range temperature drop with door down Front door access One iris port on each lateral side two irises on front and back or doors for access Hood can be raised separately from front door Mattress with minimum surface of 2 000 cm2 Tilting of the mattress Tubing access minimum 4 b Temperature controller Microprocessor controlled Automatic test on start up Heat up time to 39 C to be 30 minute or less Removable control unit for easy service Air flow pattern directed from front to rear of incubator across entire width Centralized display for pa
46. temperature minimum 20 30 C Ambient humidity 0 90 RH 8 5 Warranty and Service Conditions 24 months from the moment of installation Maximum response time at beneficiary site 72 hours 8 6 Incidental Services Training for at least 2 medical personnel on site at beneficiary location in Russian language Training for at least 2 technical personnel on site at beneficiary location in Russian language Installation and commissioning User manual in English or translated into Russian language Item Quantity ITEM 9 SYRINGE INFUSION PUMP 11 9 1 Standard requirements 1 Compliant to EU Medical devices Directives CE Mark 2 Compliant to IEC 60601 and amendments for Medical electrical equipment ISO 9001 certified companies 9 2 Basic Structure Equipment for iv administration of drugs at controlled quantity and time 9 3 Technical Characteristics Syringe type infusion pump for constant drug administration Flow rate min range 0 1 ml 999 ml h max 0 1 ml increments Possibility of changing the flow rate whilst infusing Syringe loading sensor The equipment will include KVO function High accuracy over the entire delivery range min 5 Accept all standard type syringe from 50 60 ml 30 35 or 20 ml 10 ml or 5ml Set up fast and simple Bolus mode programmable Antibolus system Warns of pressure variation when th
47. tient air temperatures control with alarms display for function settings parameters and trending easy to operate and clean Accurate air temperature control using two air probes Air temperature range between 20 and 39 C Baby temperature control using reusable skin probe Baby skin temperature range between 35 and 37 C Keypad lock function for protection Override function at air temperature over 38 C c Standard humidity module Internal reservoir included Front mounted for easy accessibility All humidifier parts can be completely removed for filling and cleaning Humidity range up to 0 80 RH d Mobile stand Stand on four anti static wheels from which two locking Height variable 90 110cm or more Two front drawers e Alarms audio alarms Baby set temperature 1 C High Low air temperature 3 1 Cor better Baby skin temperature probe fail Air temperature probe fail Power fail Air flow fail System fail f Accessories included Front drawers 2 pieces Mattress 1piece 16 Item Quantity ITEM 8 BASIC INCUBATOR 3 8 4 Accessories Rails for accessories 2 pieces Patient skin probe reusable 2 pcs g Physical properties Interior Noise level lt 60dB Interior Aer flow lt 35m s Power requirements 220 240 V 50 60 Hz Ambient operating
48. y Compact breathing system integrated in basic unit Vaporizing system for two vaporizers with interlock system Monitoring and measurement of ventilation parameters and gas parameters integrated in the basic unit Unit for bronchus aspirator Unit for monitoring vital parameters heart rate ECG blood pressure saturation of oxygen and temperature Trolley with antistatic casters two locking drawers unit Unit shall be equipped with all necessary accessories min the following pressure reducers connecting hoses reusable breathing hoses vaporizer sensors filters bronchus aspirator etc ready to work Integrated anesthetic gas scavenging Auto self check by start routine Uninterruptible power supply 220VAC 50Hz integrated in the basic unit Technical requirements for breathing system Compact breathing system integrated in the basic unit with 6 Item Quantity _ ITEM 3 ANESTHESI A MACHINE D 1 3 2 Basic Structure integrated infinitely adjustable positive pressure valve Integrated quick vent valve for rapid manual pressure relief of breathing system Integrated pneumatic and electric interface for hoses and cables connection of compact breathing system and basic unit as regards fresh gas supply flow and pressure measurement sample gas return flow and possibility of gas scavenging Possibility for connection for neonates

ITB14/00855 Annex 1 to Section 3 (amended)

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