Lot No. and Item

Product Description

Quantity

1.Gynecological examination chair electrical

Gynecological examination chair designed for gynecological examination, diagnosis and treatment with electrical position adjustment. Gynecological Examination chairs will be used in stationary condition in Health centers, District hospitals in a fixed position.

Technical specifications:

• Operation: Electric,
• Number of sections: at least 3 sections (backrest, seat and detachable footrest).
• Structure made at least of steel tube with anticorrosive finish in epoxy/electrostatic paint or higher quality.
• Synthetic and fireproof M2 upholstered in leather or similar, high density (approx. 25Kg/m3), divided in 3 sections with independent movements.
• With gynecological hollow in the pelvic area.
• Mounted on four (4) non-slip and adjustable rubber feet for levelling of the chair.
• Load weight capacity min.: 160 kg.
• Total width: at least 60 cm
• Total Length: at least 175 cm

Electric movements with manual remote control:

• Adjustable height at least between 65 cm and 90 cm.
• Adjustable backrest and seat.
• Trendelenburg and anti-Trendelenburg positioning.
• Remote Control with movement blocking function and membrane or contact buttons.

Electrical Requirements

• Voltage: 230 V, 50 Hz
• Plug type: C or F
• All electrical connection according with the destination Country standards (Ukraine)

Accessories:

• Detachable footrest.
• Set of leg supports for the adjustment in all planes.
• Fluid Bowl made of Stainless Steel or Steel with anticorrosive finish.
• Integrated roll paper holder

10 pcs

Documentation requirement:

• Instructions for use and service manuals to be provided (including procedures for decontamination).
• Indications in the language of the destination country (Ukraine) or at least in English as mandatory.
• Contact details of manufacturer, supplier and local service agent must be provided.
• Certificate of calibration and inspection to be provided, if applicable.
• List of equipment and procedures required for local calibration and routine maintenance must be provided.
• List of common spare parts and accessories with part numbers must be provided.
• Manufacturer authorization.
• Free sale certificate of origin country if other than Ukraine.
• Approval letter or certificate from national Ukrainian regulatory body (which confirms local registration of the product and permission to use in medical practice).

Other requirements:

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

Regulatory approvals required: 

• National Regulatory Agency/Authority (NRA) requirements compliance.
• And at least one of the follows:

• CE mark Comply to EU Council Directive 93/42/EEC (MDD) or EU Regulations2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
• FDA (Food and Drug Administration) of the USA that certifies marketing permission in the United States.
• Other regulatory body of an IMDRF founding member country such as Australia, Canada, or Japan.

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 & product Standards:

Bidder shall furnish the documentary evidence to demonstrate that the good it offers meet the international safety & regulatory standards providing a signed and dated Declaration of Conformity (DoC) according to ISO 17050 stating compliance to the follow standards:

• 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

Contact person

Iryna Bohun

Email address

ua-procurement@unfpa.org

Lot No. and Item No.

Quantity, pcs

Unit price, USD, CPT (Kyiv)

Total price, USD, CPT (Kyiv)

Delivery schedule (weeks)

1.Gynecological examination chair electrical

10

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).

Name of company

Contact person

Telephone

E-mail

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