Equipment Specifications for Complete Monitoring

Equipment Specifications for Complete Monitoring
System for ICU (REVISED)
UNSPSC Code:
ECRI Code:
1 Description of Function
1.1 Critical patients need to be monitored continuously in ICU
at the bedside as well as at the central nursing station.
2 Operational Requirements
2.1 ICU should comprise of monitors at the bedside and with
central station.
2.2 Capability of storage of patient data and printing of patient
reports.
2.3 Demonstration of the equipment is a must.
3 Technical Specifications
3.1 Minimum 15 inches multi colored TFT display screen.
3.2 Separate CPU/Module rack.
3.3 Eight digital and waveforms/traces display
3.4 Combination of single, dual and multi parameter
modules.
3.5 Parameter modules freely exchangeable between all the
monitors.
3.6 Multi channel (up to 12 leads) ST segment analysis.
3.7 Facility to monitor and display - ECG, Respiration, NIBP,
SpO2, CO2 with capnography, Temp, Cardiac output
(optional), NMT (Optional), BIS/Entropy (optional), EEG
(optional)& IBP – 2 Nos.
3.8 Automatic arrhythmia detection & alarm for standard and
lethal arrhythmia.
3.9 EtCO2 -Main stream/ side stream. Display both inspired
and expired values, showing capnography.
3.10 NMT Module/monitor: For measurement and display of
TOF count, TOF %, ST, DBS, Tetanic and Trend for
continuous usage. Automatic measurement facility in
selected time interval. Automatic selection of
supramaximal current. Include standard accessories.
(Optional)
3.11 EEG Module with all accessories. (Optional)
3.12 Central station for bedside monitors with independently
controlled. 17" multi color TFT Monitor, complete with
Ethernet LAN cabling, alarm management, 72 hours
trending, bed to bed viewing of waveforms and remote
alarm management like silencing of alarms etc.
3.13 Should provide hemodynamic, oxygenation, Ventilation
calculation package.
3.14 Should have drug calculation package.
3.15 Trend of at least 48 hours.
3.16 200 nos. event recall/snapshot facility both manually and
automatically triggered by alarm.
3.17 Automatic Zoom In Facility in the monitor display.
3.18 The monitors should have monitor-to-monitor overview
facility and data transfer over the network.
3.19 Web browsing facility to review each networked monitors
data through hospital LAN via office PC in Hospital LAN
Network and/or through dial up facility from remote
location (OPTIONAL)
3.20 CRT Slave monitors- 21 inches in ICU - one per central
station
3.21 Communications with Information Management Systems:
A. To provide HL-7 compatible server for sending and
receiving information to and from the monitoring network
to and from Hospital Information System, Laboratory
information etc for integration of various information
(OPTIONAL)
B. To provide suitable facility for sending and receiving
DICOM Compatible Radiological Images like Ultrasound,
X-Ray etc to and from the monitoring network to and
from Hospital Information System, Radiology Information
System etc for integration of various information
(OPTIONAL).
3.22 Include Laser Printer and dual channel strip chart
recorder.
3.23 Specifications for Transport Monitor:
1.Portable and light weight preferably< 10 kg.
2.Modular with 12 inches multi color TFT Display.
3.Monitoring Parameters - ECG, Respiration, NIBP, SaO2
and temperature.
4.Digital and six waves/traces display.
5.Trends up to 24 hours.
6.60 minutes or more battery backup.
7.Convenient handle for carrying the same.
8. Able to fix with bed/ trolley.
4 System Configuration Accessories, spares and consumables
4.1 ECG/Resp: 5 Lead ECG Cable with clip- 2 sets per monitor
and 10 Lead ECG Cable with clip- 1 set per monitor.
4.2 NIBP: Adult cuff- 2nos. per monitor and two sizes of
pediatric cuffs- one per monitor (complete sets)
4.3 Reusable SPO2: Adult SPO2 sensor with cable- two nos.
per monitor and Pediatric SPO2 sensors- one no. per
monitor.
4.4 IBP: Include four nos. per monitor of reusable pressure
transducer with bracket, holder and 100 nos. disposable
domes per monitor.
4.5 Temperature: Rectal temperature probe- two per monitor
and skin temperature probe- one per monitor.
4.6 EtCO2 module with all accessories. In case of side stream
EtCO2-10 sets of sampling tubes for each module to be
included.
4.7 Cardiac Output: Should be by thermodilution method with
all accessories
4.8 EEG Modules- with all accessories. Should display at least
two channels. (Optional)
4.9 BIS/Entropy Module: Adult Sensors-200 numbers.
Spectral analysis modules by compressed spectral array.
(Optional)
4.10 Necessary cabling for networking the monitors on turnkey
basis.
4.11 Necessary mounting solution/ mounting on any pendant
for monitors
5 Environmental factors
5.1 The unit shall be capable of operating continuously in
ambient temperature of 10 –40 deg C and relative
humidity of 15-90%
5.2 The unit shall be capable of being stored continuously in
ambient temperature of 0 –50 deg C and relative humidity
of 15-90%
5.3 Shall meet IEC-60601-1-2: 2001(Or Equivalent BIS)
General Requirements of Safety for Electromagnetic
Compatibility or should comply with 89/366/EEC; EMCdirective.
5.4 The supplier shall provide environment friendly furnitures
and wall fittings for the entire system. Cabling has to be
provided by the supplier.
6 Power Supply
6.1 Power input to be 220-240VAC, 50Hz fitted with Indian
plug
6.2 Voltage corrector/stabilizer of appropriate ratings meeting
ISI Specifications. (Input 160-260 V and output 220-240 V
and 50 Hz)
6.3 Suitable UPS with maintenance free batteries for minimum
one-hour back up should be supplied with the system.
7 Standards, Safety and Training
7.1 Should be FDA, CE, UL or BIS approved product
7.2 Shall meet the safety requirements as per IEC 60601-2-
27:1994—Medical electrical equipment—Part 2: Particular
requirements for the safety of electrocardiographic
monitoring equipment.
7.3 Manufacturer/Supplier should have ISO certification for
quality standards.
7.4 Should have local service facility .The service provider
should have the necessary equipments recommended by
the manufacturer to carry out preventive maintenance test
as per guidelines provided in the service/maintenance
manual.
7.5 Back to back warranty to be taken by the supplier from the
principal to supply spares for a minimum period 10 years.
7.6 Comprehensive warranty for 5 years and provision of AMC
for next 5 years.
8 Documentation
8.1 User Manual in English
8.2 Service manual in English
8.3 Must submit user list and performance report within last 5
years from major hospitals.
8.4 Compliance Report to be submitted in a tabulated and point
wise manner clearly mentioning the page/Para number of
original catalogue/data sheet. Any point, if not
substantiated with authenticated catalogue/manual, will not
be considered.
8.5 List of Equipments available for providing calibration and
routine Preventive Maintenance Support as per
manufacturer documentation in service/technical manual.
8.6 List of important spare parts and accessories with their part
number and costing.
8.7 Log book with instruction for daily, weekly, monthly and
quarterly maintenance checklist.
The job description of the hospital technician and company
service engineer should be clearly spelt out