Lot No. and Item

Product Description

Quantity

1. Colposcope

• Magnification: A range of optical magnification between 3x to

15x (either stepped or continuously variable)

• Illumination: Light source LED  20,000-35,000 LUX (at 300 mm working distance)

- Zoom, green filter, focus manually and adjust light brightness by hand controller

• Ingress protection rating: IPX2 (minimum)

Software

Colposcope software should be in English as mandatory and Russian (Ukrainian language, if available)

- Data storage: 200 or more - standard pictures

- Multi-model (case number, name, age, date, etc) index, lookup, analyze, edit and print. Printing of Multi-format diagnosis report

- Acetic acid test timer function, real-time display of acetic iodine reaction tests.

Parameters:

Camera System：1/4 inch. Fast auto focus/manual focus/

Effective Pixel：>=800,000 pixels

Resolution: 550 lines

Signal Noise Ratio of lens: >=50dB

Focusing distance: 20-40mm

Electrical Requirements

Voltage: 230 V, 50 Hz

Plug type: C or F 

All electrical connection according with the destination Country standards (Ukraine)

Accessories:

- Upright Stand, easy to move, with fastening to a chair to allow for hands-free operation

• LED TV or medical grade monitor if not integrated (optional)

Documentation requirement:

• Instructions for use and service manuals to be provided (including procedures for decontamination)

• User language preference prioritized, English is mandatory.

• Contact details of manufacturer, supplier and local service agent.

• Certificate of calibration and inspection to be provided

• List to be provided of equipment and procedures required for local calibration and routine maintenance.

• List to be provided of common spares and accessories, with part numbers.

Other requirements.

1.  All standard accessories, consumables and parts required to operate the equipment, including all standard tools, cleaning and lubrication materials.
2. At least two (2) years of full onsite warranty including 2 yearly preventive maintenances, full corrective maintenance including works and spare parts.
3. Training on use, cleaning, disinfecting and basic maintenance on-site or in teleconference for at least 4 hours.

Regulatory approvals: Compliance to

- National Regulatory Agency/Authority (NRA) requirements compliance

And at least one of:

- FDA 510k clearance (US FDA)

- CE mark (EU), with indication of Notifying Body

- Other regulatory body in an IMDRF founding member country such as Australia, Canada, or Japan.

Manufacturer authorization

QMS

For general manufacturing

• ISO 13485: Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes

• ISO 14971: Medical Devices - Application of Risk Management to Medical Devices

• ISO 15223-1: Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements

Safety and product standards: Declaration of Conformity by the Manufacturer is acceptable

• IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

• IEC 60601-1-2: Medical electrical equipment - Part 1-2 General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests                                                                                        For vaginally-inserted colposcopes:

• Biocompatibility: Declaration of Conformity by the Manufacturer is acceptable

o ISO 10993-1: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

o ISO 10993-5: Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity

o ISO 10993-10: Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization

• Endoscopy (pertaining to inserted scope):

o ISO 8600-1: Endoscopes – Medical endoscopes and endotherapy devices – Part 1: General requirements

o ISO 8600-3: Optics and optical instruments – Medical endoscopes and endoscopic accessories – Part 3: Determination of field of view and direction of view of endoscopes with optics

o ISO 8600-4: Endoscopes – Medical endoscopes and endotherapy devices – Part 4: Determination of maximum width of insertion portion

o ISO 8600-5: Optics and photonics – Medical endoscopes and endotherapy devices – Part 5: Determination of optical resolution of rigid endoscopes with optics

o ISO 8600-6: Optics and photonics – Medical endoscopes and endotherapy devices – Part 6: vocabulary

 7 pcs

2. 12 channel ECG device

12-channels ECG portable device used for Electrocardiogram (ECG) examinations.

General Specifications:

12 electrographic standard leads measuring with simultaneous acquisition.

Visualization of at least one group of 3 leads simultaneously.

At least one ECG patient cable with at least 5 terminals.

At least 8” LCD or TFT color display with visualization of: analogical curves, alphanumeric values and the related physiological limits.

Screen resolution >=128 х 64 pixels;

Keyboard- combined alphanumeric and functional keyboard and buttons;

Number of leads  12;

Bandwidth in monitor mode not smaller than 0.5 to 100 Hz 

Modes of operation: automatic and manual.

Equipment compatible with patients with pacemakers.

All software in English (as mandatory) and Russian, Ukrainian language (if available).

Protection against defibrillation.

Automatic internal data storing up to at least 40 ECG records.

Input impedance not less than 5MΩ.

Patient leakage current no higher than 10uA.

Common Mode Rejection (CMRR) not less than +100dB.

ECG signal measurement range not smaller than -2 mV to +2 mV.

At least the following adjustable alarms:

1. Heart failure;
2. Ventricular fibrillation;
3. Tachycardia;
4. Bradycardia;
5. Electrode disconnection;
6. Open lead;
7. Low battery visual alarm;

Equipment provided with at least the following software applications:

1. Arrhythmias detection and analysis;
2. Ventricular fibrillation detection and analysis;
3. Ventricular tachycardia detection and analysis;
4. ST segment analysis;

Automatic equipment calibration.

RS232 or USB port for PC connection and data transmission, WiFi (optional).

With filters at least for baseline instability filter muscle artifacts, AC interference and other devices.

Printer

Integrated printer using standard A4 format paper and different report print formats available.

Print type - Thermal 

Paper type - roll 

Selectable printing paper speed at least of 5, 25 and 50 mm/sec.

Electrical requirements:

210 to 240 V, 50 Hz

Plug type: F

Integrated batteries charger with AC power cable and rechargeable batteries with continuous monitoring working time of no less than 1 hour or 100 ECG.

Protections against over-voltage and over-current line conditions.

All electrical connection according with the destination Country standards (Ukraine)

Accessories to be included:

Two (2) lead patient cables with at least five terminals, reusable type

Eight (8) reusable clip clamp electrodes, reusable type

Two sets of twelve (12) reusable suction ball-type chest electrodes, reusable type

Two (2) bottles of gel for body-connection electrodes.

Two (2) rolls of ECG thermal paper.

Documentation requirements

• Software licenses and user and maintenance manuals.

• Instructions for use and service manuals to be provided (including procedures for decontamination)

• User language preference prioritized, English is mandatory.

• Contact details of manufacturer, supplier and local service agent.

• Certificate of calibration and inspection to be provided

• List to be provided of equipment and procedures required for local calibration and routine maintenance.

• List to be provided of common spare and accessories, with part numbers.

Other requirements.

4.  All standard accessories, consumables and parts required to operate the equipment, including all standard tools, cleaning and lubrication materials.
5. At least two (2) years of full onsite warranty including 2 yearly preventive maintenances, full corrective maintenance including works and spare parts.
6. Training on use, cleaning, disinfecting and basic maintenance on-site or in teleconference for at least 4 hours.

Regulatory approvals: Compliance to

- National Regulatory Agency/Authority (NRA) requirements compliance

Free Sales certificate

And at least one of:

- FDA 510k clearance (US FDA)

- CE mark (EU), with indication of Notifying Body

- Other regulatory body in an IMDRF founding member country such as Australia, Canada, or Japan.

Manufacturer authorization

QMS

ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes).

General quality management (e.g. ISO 9001:2015 Quality management systems – Requirements).

Application of risk management to medical devices (e.g. ISO 14971:2019 Medical devices – Application of risk management to medical devices).

Safety and product standards: Declaration of Conformity by the Manufacturer is acceptable

IEC 60601-1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.

IEC 60601-1-2:2007 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests.

IEC 60601-1-8:2012 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.

IEC 60601-2-25:2011 Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs.

IEC 60601-2-27:2011 Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment.

IEC 60601-2-49:2011 Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment.

7 pcs

3. Portable Ultrasound Scanner

General information: Multipurpose combined console/digital platform for general, abdominal, cardiological, musculoskeletal, vascular (including transcranial), pediatric (including neonatal) studies.

Application: adult, pediatric and neonatal patients

1. General specifications:

• Connection of at least 3 probes at the same time plus the probe for the Doppler CW.
• Color Monitor LCD/TFT of at least 17’’.
• Illuminated alphanumeric keyboard.
• Frequency range of at least 1 – 15 MHz.
• Dynamic range of at least 180 dB.
• Penetration depth of at least 30 cm.
• Frozen image zoom of at least 10X.
• Dynamic real time zoom of at least 4X.
• All software in English (as mandatory) and Russian, Ukrainian language (if available).

2. The hardware and software included in the offer will allow the following application:

• cardiac; cardiac quantification
• abdominal; (including the study of abdominal vessels in Doppler modes),
• muscular; (including examination of the vessels of the extremities in Doppler modes) and examination of small organs.
• obstetrical and gynecological; in obstetrics (including advanced perinatology), including gestational sac mean diameter, femur length, crown-rump length, biparietal diameter and abdominal circumference, enabling estimation of gestational age and foetal weight (preferable);
• Small parts and tissues
• examination of the mammary glands, examination of the thyroid gland (including examination of the vessels of the neck in Doppler modes),
• peripheral and deep vascular; Research in angiology (including abdominal, peripheral and superficial vessels)

3. Images Modes, at least:

• 2-D imaging
• M-mode
• B/M mode
• Dual 2-D/colour image mode cine loop
• CFI Doppler
• PDI (Power Doppler Imaging),
• PW (Pulsed Wave Doppler)
• CW (Continuous Wave Doppler)
• Needle enchancement ability

4. Allowed measurements:

• body marks;
• length;
• angle;
• area;
• circumference;
• cavities;
• speed;
• flow.

5. Software included functions, at least:

• trapezoidal images;
• vascular examinations;
• fetal weight indexes table;
• production and storage of images and videos;
• steering pulsed Doppler.

6. Allowed probes:

• linear;
• convex;
• endocavity;
• transesophageal;
• microconvex;
• phased array;
• pencil.

7.  Communication and storage

• DICOM 3.0 conformity.
• Capability for database of patient images and information.
• Hard disk of at least 1 TB.
• At least one USB port and high-definition multimedia interface (HDMI) preferable.

8. Probes to be included:

• Convex with at least triple frequency, bandwidth of at least 3Mhz, including 3.5Mhz frequency; (Used for Abdominal, OB/GYN, Abdominal Vessels, etc.), Supports Biopsy Adapters
• Linear with at least triple frequency, bandwidth of at least 2Mhz, including 6.5Mhz frequency; used for vascular, superficial and small organs, thyroid and breast, musculoskeletal), supports biopsy adapters
• Phased array with at least triple frequency, bandwidth of at least 2 Mhz including 3 Mhz frequency;
• Transvaginal transducer: 4.0-12 MHz (used for endovaginal, endorectal examinations)

9. Accessories to be included:

• B/W printer for medical ultrasound applications.
• 5 liters of ultrasound gel.
• Compatible printing paper

Image Enhancement Software Package:

• (tissue or 2nd harmonic) for all sensors,

• multi-angle composite scanning, to eliminate artifacts and shadows from hypoechoic structures,

• Speckle-grain reduction algorithm,

• contrast enhancement technology,

• multi-beam scanning technology,

• technology of automatic amplification of the color range

10. Electrical Requirements:

Voltage: 230V, 50 Hz

Plug type: F

Protections against overvoltage and overcurrent line conditions.

All electrical connection according with the destination Country standards (Ukraine)

Working time in battery mode and standard operations not less than 2 hours.

Battery recharging time not more than 4 hours.

11. Documentation requirements

• Software licenses and user and maintenance manuals.

• Instructions for use and service manuals to be provided (including procedures for decontamination)

• User language preference prioritized, English is mandatory.

• Contact details of manufacturer, supplier and local service agent.

• Certificate of calibration and inspection to be provided

• List to be provided of equipment and procedures required for local calibration and routine maintenance.

• List to be provided of common spares and accessories, with part numbers.

12. Other requirements.

• All standard accessories, consumables and parts required to operate the equipment, including all standard tools, cleaning and lubrication materials.
• At least two (2) years of full onsite warranty including 2 yearly preventive maintenances, full corrective maintenance including works and spare parts.
• Training on use, cleaning, disinfecting and basic maintenance on-site or in teleconference for at least 4 hours.

Regulatory approvals: Compliance to

- National Regulatory Agency/Authority (NRA) requirements compliance

Free Sales Certificate

And at least one of:

- FDA 510k clearance (US FDA)

- CE mark (EU), with indication of Notifying Body

- Other regulatory body in an IMDRF founding member country such as Australia, Canada, or Japan.

Manufacturer authorization

QMS

ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes).

General quality management (ISO 9001:2015 Quality management systems – Requirements).

Application of risk management to medical devices (ISO 14971:2019 Medical devices – Application of risk management to medical devices).

Safety and product standards: Declaration of Conformity by the Manufacturer is acceptable

·         ISO 29821:2018 Condition monitoring and diagnostics of machines – Ultrasound – General guidelines, procedures and validation.

·         IEC 60601-1:2005- Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.

·         IEC 60601-1-2:2014 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests.

·         IEC 60601-2-37:2007 Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.

·         IEC 61157:2007 – Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment.

·         IEC 60601-1-4 Medical electrical equipment – Part 1-4: General requirements for safety – Collateral standard: Programmable electrical medical systems.

7 pcs

Contact person

Iryna Bohun

Email address

ua-procurement@unfpa.org

Lot and Item No.

Quantity, pcs

Unit price, USD, CPT (Kyiv)

Total price, USD, CPT (Kyiv)

Delivery schedule (weeks)

1. Colposcope

7

2. 12 channel ECG device

7

3. Portable Ultrasound Scanner

7

3.1         Is the product CE marked?

Certification body and number:
Click here to enter text.

□            Yes

Start Date: Click here to enter text.
Expiry Date: Click here to enter text.

□            No

3.2         Is the product FDA approved?

            510k clearance #: Click here to enter text.
            PMA clearance #: Click here to enter text.

□            Yes

Start Date: Click here to enter text.
Expiry Date: Click here to enter text.

□            No

3.3        Is the product approved by National Regulatory Agency or Department?

Name of agency and type of approval: Click here to enter text.

□            Yes

Start Date: Click here to enter text.
Expiry Date: Click here to enter text.

□            No

3.4        Provide details of any other current regulatory approvals for this product.

Name of jurisdiction and type of approval: Click here to enter text.

□            Yes

Start Date: Click here to enter text.
Expiry Date: Click here to enter text.

□            No

Name and address of the subcontractor

QMS certification of the subcontractor - Identify Regulatory body and/or number and expiry date

Click here to enter text.

Click here to enter text.

If the device contains Lithium metal and Lithium ion batteries, does it comply with clause 38.3 of the recommendations on “Transport Of Dangerous Goods” from the United Nations?

        Yes ☐       No ☐

Does it comply with the latest IATA Dangerous Goods Regulations (DGR)?

        Yes ☐       No ☐

Testing laboratory, Test Report reference, specify standard

Click here to enter text.

Product class
(EC MEDDEV)

Minimum documentation required
Documents to be submitted must be true and valid copies. All documents submitted must be in English or be accompanied with certified translation.

class I
(non-measuring, non-sterile and/or
non-reusable surgical instrument, rsi)

☐  Copy of ISO 13485* (or ISO 9001*) QMS certificate.
☐  A signed and dated Declaration of Conformity (DoC) according to ISO 17050 stating compliance to the relevant ISO standards and directives (for manufacturer), and which has reference to the offered product.
☐  Photo of the product and packaging (at various angles if necessary, preferably in a format where the dimensions and features can be visually verified from the photos).

class I measuring
class I sterile
class I rsi
class IIa

☐  Copy of EC certificate (referencing the name/number of the notifying body), and/or 510k FDA clearance, and/or approval letter or certificate from a National Regulatory Body.
☐  A signed and dated DoC according to ISO 17050 stating compliance to critical ISO standards (e.g. for sterilization, ISO 13485 QMS) and directives, and which has reference to the offered product. Note: If a sterilization activity is subcontracted to a third party, ISO 13485 QMS compliance is also required from the subcontracting company.
☐  Photo of the product and packaging (at various angles if necessary, preferably in a format where the dimensions and features can be visually verified from the photos).

class IIb
class III  

☐  Copy of EC certificate (referencing the name/number of the notifying body) with an additional copy EC Design Examination certificate, and/or 510k/PMA FDA clearance, and/or approval letter or certificate from a National Regulatory Body.
☐  A signed and dated DoC according to ISO 17050 stating compliance to critical ISO standards (e.g. ISO 13485 QMS) and directives, and which has reference to the offered product. Proof of compliance to ISO standards in a form of copies of certificates shall be submitted if available.
☐  Photo of the product and packaging (at various angles if necessary, preferably in a format where the dimensions and features can be visually verified from the photos).