Technical Specifications

Version 2.0
12 January 2021

Multi-parametric patient monitors

The bidder can propose two different types of Multi-parametric patient monitors:
- “Standard” Multi-parametric patient monitors
- “Advanced” Multi-parametric patient monitors

1. Technical description for the “Standard” multi-parametric patient monitors.

The equipment shall meet the following minimum technical requirements.

Suitable for Adult, Pediatric, and Neonate Patient Support.
With the following monitored parameters: ECG, HR (Heart rate), SpO2 (Pulse Oximetry), PR (Pulse Rate),
RESP (Respiration), NIBP (Non-Invasive Blood Pressure), TEMP (Temperature).
ECG 5 leads.
Heart rate (HR): measuring range up to 250 bpm.
Pulse Oximetry (SpO2): 1 to 100%, pulse rate (PR): up to 240 bpm.
Respiration (RESP): measuring range 0 to 120 bpm, with apnea detection adjustable by the user.
Non-invasive blood pressure (NIBP): manual, continuous (up to 5 min) or STAT mode.
With an overpressure protection for the NIBP cuff.
Temperature (TEMP): 1 channel, range up to 45°C, accuracy ± 0.1° C.
With adjustable, visual and audible alarms, with 3 levels of priority (high, medium, low).
LCD/TFT display, with simultaneous display of minimum 4 traces and 8 vital parameters.
With a Multilanguage interface. English language must be included as a minimum.
Data storage 24 hours minimum. Export via SD card or USB port.
Connectable to network, via Ethernet or wireless.
Shall be compatible with power supply 220V/50Hz, and delivered with a European plug IEC Type C or F.
With a rechargeable removable battery, with minimum 2 hours of autonomy in use.
The device shall comply with international standards related to the electrical safety of medical devices,
and related to patient monitoring systems: IEC 60601‐1, IEC 60601‐1‐2, IEC 60601-1-8, IEC 60601-2-27,
IEC 60601-2-30, IEC 60601-2-49, ISO 80601-2-56, ISO 80601-2-61…
The device shall be CE marked in accordance with the European Medical Devices Regulation MDR (EU)
2017/745 or the previous Directive ECC/93/42.
The manufacturer of the proposed product shall be certified against the ISO 9001 or the ISO 13485 for the
manufacturing of Medical Devices.
The equipment shall be delivered with all necessary accessories and consumables for correct operation
and direct use on patient. In particular, it shall include the following items with their cables:
• SpO2 reusable probe, for adult, quantity 1.
• SpO2 reusable probe, for pediatric, quantity 1.
• NIBP cuff, with hose, for adult, in two different sizes, quantity 1 cuff of each size.
• NIBP cuff, with hose, for pediatric, in two different sizes, quantity 1 cuff of each size.
• Temperature reusable probe, skin, quantity 1.
• Reusable ECG cable, quantity 1.
• Disposable ECG electrodes, quantity for 50 patients.

The equipment shall be delivered with the following documentation:

• Qty 1 User manual, in paper format and in electronic format, in English language (NSPA reserves
the right to request another language at the time of order, based on the manufacturer’s
capabilities).
• The EU Declaration of Conformity in accordance with the EU regulation 2017/745 or the
European Directive 93/42/EEC for Medical Devices.
• The Certificate of Conformity, from the manufacturer, certifying that the delivered devices,
identified by serial numbers, were successfully tested according to the factory specifications and
good manufacturing practices before the delivery.

2. Technical description for the “Advanced” multi-parametric patient monitors.

This category of patient monitors shall meet the minimum technical requirements as described in
paragraph 1, and shall in addition meet the following requirements:
- With the additional following monitored parameters:
o IBP (Invasive blood pressure);
o Capnography.
- ECG 12 leads.
- Invasive blood pressure: -30 to 300 mmHg.
- Capnography: 0 to 80 mmHg.
- Shall be delivered with the additional following accessories:
o Reusable IBP cable, quantity 1.
o Disposable IBP transducers, quantity 10.
o Capnography sets (cable, sensor, patient line, airway adapter…), quantity for 10 patients.

3. Commissioning and training.

After the delivery, the contractor shall ensure that the delivered equipment is operating in accordance
with the manufacturer’s specifications and is safe for use on patients. The contractor shall provide to NSPA
and to the end-users a documented evidence of the commissioning outcome before the first use on
patients.
After the commissioning, the contractor shall provide training services to the end-users, in English
language (NSPA reserves the right to request another language at the time of order, based on the
Contractor’s capabilities). NSPA will confirm the address of the training location at the time of order.

At the end of the course, the trainees shall be familiar with the concepts of use of the device, the safety
recommendations, the cleaning procedures, and the user level maintenance operations if applicable. The
trainees shall be able to use safely the system, in accordance with the manufacturer’s recommendations.

NOTE: Considering the current restrictions of travel due to the Covid-19 pandemic, the contractor is invited
to provide also a remote solution, via an e-learning platform or the provision of CD-ROM for example.

4. Follow-on support.

The contractor shall have the capability to provide technical support to the end-users. This could include
for example the following services: troubleshooting, delivery of spare parts, preventive or corrective
maintenance operations.

The contractor shall have a reliable supply chain to sustain future requests for the provision of supplies
(accessories, consumables, software options). To this end, the contractor shall be able to provide any
parts or software options that are essential for the use of the offered device, and shall have a list of
supplies and configuration options compatible with the offered equipment.

The Contractor shall describe its existing service support capability.