Annex A –Physiologic Monitor, MRI Compatible
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Annex A
Technical
Specifications
Physiologic
Compatible
Monitor,
MRI
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Aug 2011
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Annex A –Physiologic Monitor, MRI Compatible
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Technical Specifications for Physiologic Monitor, MRI Compatible
1.
Functional Requirements
1.1
The unit shall be MRI compatible and functional inside a 3 Tesla MRI scanner room.
1.2
The patient physiological monitor shall be measuring patient undergoing MRI scan for
ECG/RESP, NIBP, and SpO2 .
1.3
The unit shall be designed for used on a wide range of patients, ranging from adults to
infants.
2.
General Requirements
2.1
The unit shall be modular in designed and able to measure simultaneously the following
parameters as a basic configuration :
a)
b)
c)
d)
Electrocardiogram (2 –lead ECG) x 1;
Non Invasive blood pressure(NIBP) x 1;
Respiration x 1;
Pulse Oximetry (SpO2) x 1;
2.2
The unit must be MRI compatible.
2.3
The unit shall be solid-state, microprocessor-based design.
2.4
The unit shall be compact, light-weight, rugged, shock proof and water resistant.
2.5
The equipment shall be mounted on mobile trolley for the monitoring.
2.6
The unit shall equipped with trending capability for all parameters, with an adjustable trending
time from 30 minutes to 72 hours.
2.7
The unit shall be equipped with a comprehensive alarm system for all measured parameters.
2.8
The unit shall be capable of displaying at least 6 waveforms and configured displays for
colour/waveforms/numerical data.
2.9
The unit shall have be capable of connecting to a recorder which can print up to two (2)
waveforms as well as real-time and trends of vital signs, patients data and date/time information.
2.10
The unit shall have a clear screen visibility for waveforms and numeric display to be read at a
distance of at least four (4) metres away from the monitor screen.
2.11
The unit shall be equipped with protection against damage from defibrillation and electrosurgery.
2.12
In addition to 2.1, optional configured parameters or modules shall be made available for
monitoring the following parameters if needed :
a)
Invasive Blood Pressure;
b)
2-channel recorder (built-in or plug in);
c)
Neuromuscular transmission;
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Annex A –Physiologic Monitor, MRI Compatible
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d)
End Tidal Carbon Dioxide;
e)
Bispectral Index(BIS) module;and
f)
temperature.
2.13
The unit shall be equipped with automatic self-diagnostic program that detect and clearly indicate
any defects and malfunction upon start-up.
2.14
The unit must be equipped with an internal MIB interface embedded in the unit at the point of
manufacture.
2.15
The system shall be designed to permit extension or upgrades to more advanced systems and
capabilities. Documentary evidence in support of upgradeability shall be furnished during the
submission.
3.
Electrical Requirements
3.1
The unit shall be fully conform to IEC 60601-1 Class 1,Type CF for its electrical specification.
3.2
The unit shall operate directly from a 230V ± 10%, 50 ± 2 Hertz, single phase AC supply as well
as its own internal, rechargeable battery for more than 2 hours of monitoring.
3.3
All accompanying sub system and accessories shall be fully integrated, with a single moulded
construction type power plug.
3.4
The unit shall be protected from transient power disruptions during use. The disruption shall not
affect the performance of the unit.
3.5
The unit shall be equipped with self-tripping circuit breaker for protection against overload.
4.
Safety Requirements
4.1
The construction of the unit shall ensure a sufficient degree against safety hazards caused by
overflow, spillage, leakage, humidity and ingress of liquids, cleaning, sterilisation and
disinfections.
4.2
The enclosure shall be secure and provide adequate protection against moving and
electrically energised parts.
4.3
Switches and controls should be protected against penetration of fluids.
4.4
Switches and controls shall be protected against accidental setting changes.
4.5
The controls (i.e. switches, knobs, etc.) should be visible and clearly identified, and their
function should be self-evident. Device design should prevent misinterpretation of displays
and controls settings.
4.6
The unit should resist tipping over during use and transport.
5.
Standards
5.1
The system shall fully conform to the following (or equivalent) :
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Annex A –Physiologic Monitor, MRI Compatible
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a.
IEC/EN 60601-1, General safety requirements for medical electrical equipment;
b.
IEC/EN 60601-1-2, Standard for Electromagnetic Compatibility – Requirements and
tests;
c.
IEC/EN 61000-4-x series, Safety requirements and tests for Electromagnetic
Compatibility,Immunity;
d.
IEC/EN 60601-2-25, Particular requirements for the safety of electrocardiographs;
e.
IEC/EN 60601-2-27, Particular requirements for the safety of electrocardiographic
monitoring equipment;
f.
ANSI/AAMI EC 11 (1982) - requirements for Diagnostic Electrocardiograph
Devices.
g.
IEC/EN 60529 (1989), Degrees of protection provided by enclosures (IP code).
h.
All Particular requirements for safety and performance of the tendered Article(s);
i.
IEEE 1073, Medical Information Bus (MIB);
j.
Software validation by FDA; and,
k.
FDA system clearance.
5.2
Contractors have to comply with Health Science Authority (HSA) Medical Device Regulation
requirements for all classes of medical devices. A copy of the HSA registration certificate must
be submitted together with the tender submission.
6.
Technical Requirements
6.1
The Tenderer shall furnish full technical specifications of the tendered Article together with the
tender submission.
6.2
ECG
a.
Frequency response
:
0.05 - 100 Hz.
b.
Common mode rejection ratio
:
 100 dB.
c.
Baseline drift
:
 100 mV.
d.
Lead selection
:
I, II, III, aVR, aVL, aVF, V leads
e.
Capbable of 2-channel ECG monitoring at the same time.
f.
Lead fault detection
:
Yes.
g.
Pacer detection and display
:
Yes.
h.
Heart rate ( minimum range )
Accuracy
:
:
0 - 300 bpm.
 ± 1 %.
Alarm limits, adjustable - high
- low
:
:
5 - 300 bpm.
10 - 300 bpm.
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Annex A –Physiologic Monitor, MRI Compatible
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6.3
6.4
i.
Defibrillator discharge protection
Baseline recovery time
j.
ST segment monitoring & analysis and Arrhythmia detection shall be offered as an
optional feature.
Respiration
a.
Minimum measuring range
- high
- low
tolerate 5000V, 400J.
 1 sec.
:
1 - 50 brpm.
:
:
0 - 50 brpm.
0 - 50 brpm.
b.
Alarm limits, adjustable
c.
Accuracy
:
 5%.
d.
Apnea delay alarm, adjustable
:
5 - 30s (in increments of 1 sec).
Control method, selectable
:
manual, automatic and stat.
Automatic mode
:
1 - 60 minutes (adjustable time
interval).
Manual mode
:
manually activated.
Stat mode
:
continuous for 5 minutes.
b.
Minimum measuring range
:
:
:
30 - 270 mmHg (systolic).
20 - 230 mmHg (diastolic).
25 - 250 mmHg (mean).
c.
Accuracy
:
 +/- 4 mmHg
d.
Cuff inflation speed (0 - 250 mmHg)
:
 14 sec
e.
Default cuff pressure
:
:
 180 mmHg (adult)
 120 mmHg (neonatal)
f.
Alarm limits, adjustable
:
:
15 - 260 mmHg (high)
10 - 225 mmHg (low)
g.
Maximum measuring time
:
:
 100 sec (adult)
 60 sec (neonatal)
h.
Safety cuff relief pressure
:
 301 mmHg
Non-invasive Blood Pressure
a.
6.5
:
:
Pulse Oximetry
a.
Pulse Rate Range
:
20 - 250 bpm
b.
Pulse Rate Accuracy
:
± 1.7 % of current value
c.
Oxygen Saturation range
:
0 - 100 %
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Annex A –Physiologic Monitor, MRI Compatible
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6.6
6.7
d.
Oxygen Saturation Accuracy
:
 ±2%
e.
Alarm limits, adjustable
:
:
31 - 100% (high)
50 - 99% (low)
f.
Response time
:
 8 sec (after the sensor probe is
properly connected)
g.
Averaging time, adjustable
in one second increment
:
2 - 8 sec
h.
the unit shall preferably be equipped with the following alarms/alerts
i)
probe disconnect;
ii)
probe off;
iii)
insufficient signal strength;
iv)
artifact.
i.
the unit shall be capable of producing a real-time plethysmogram while continuously
measuring and displaying patient's pulse rate.
j.
the unit shall be capable of measuring dark skin pigmentation with accurate results.
Display
a.
Type
:
Color.
b.
Minimum number of traces
:
6.
c.
Minimum display resolution
:
EVGA resolution , 1280 x 640 pixels.
d.
Size
:
15 inches diagonally.
e.
The display shall be equipped with ;
i.
a trace brightness control; and
ii.
alphanumeric display for all measuring parameters.
Invasive blood pressure (Optional)
a.
Minimum measuring range
:
- 20 - +300 mmHg.
b.
Accuracy
:
 ± 2 %.
c.
Zero balancing range
Zero balancing accuracy
Zero drift
:
:
:
± 200 mmHg.
± 1 mmHg.
 0.1 mmHg/C.
d.
Frequency response
:
DC - 20 Hz.
e.
Alarm limits, adjustable - High
- Low
:
:
0 - 300 mmHg.
0 - 300 mmHg.
f.
The module shall be equipped with the following alarms :
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Annex A –Physiologic Monitor, MRI Compatible
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g.
6.8
6.9
6.10
i)
disconnect alarm if the mean pressure falls below 10 mmHg for more than 8
seconds;
ii)
Inoperative alarm if transducer or module is disconnected or measurement is
out of range.
Ability to select labels e.g., Arterial, CVP, PA, etc.
Temperature (Optional)
a.
Minimum measuring range
:
0 – 45 C
b.
Accuracy
:
  0.1 C
c.
Alarm limits, adjustable
-High :
0 – 45 C
-Low :
0 – 45 C
End-Tidal CO2 (Optional)
a.
Minimum measuring range
:
0 - 100 mmHg Co2 partial pressure.
b.
Accuracy
:
 ± 2 % of reading.
c.
Response time
:
< 280 msec.
d.
Warm-up time (to full specification)
:
< 30 mins.
e.
Stability (over 7 days)
:
± 2 mmHg.
f.
Alarm limits, adjustable
:
:
10 - 90 mmHg.
20 - 100 mmHg.
g.
Sampling rate (for side stream)
:
 120 ml/min.
h.
Weight of transducer
(for main stream only)
:
less than 15g and shielded/protected
against heat injury to patient.
- low
- high
Neuromuscular Transmission (Optional)
a.
Modes of transmission
:
i)
ii)
iii)
iv)
Train of four;
Single twitch;
Double burst;
Tetanic.
b.
Current range into 1000 ohms
:
0 - 100 mA.
c.
Pulse width
:
100 to 300 sec.
d.
Train of four pulse repetition
:
2 Hertz.
e.
Train Of Four repetition interval
:
10sec, 20sec, 60sec, 5minutes,
20minutes, 15minutes, selectable.
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Annex A –Physiologic Monitor, MRI Compatible
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6.11
6.12
f.
Tetanus stimulation
:
g.
Capability of plexus location and stimulation.
h.
Choice of surface or needle electrodes preferred.
30 to 100 Hz.
Recorder (Optional)
a.
Type
:
Thermal array.
b.
Print function
:
able to print real-time waveform,
numeric, trend, etc.
c.
Nos. of channels
:
at least 2 user-selectable waveforms
printed simultaneously.
d.
Paper speed
:
12.5, 25, 50 mm/sec
selectable.
e.
Paper width
:
50 mm.
f.
Print resolution
:
at least 200 dots per inch.
g.
Annotation
:
Bed number, Patient name, Date &
time of event, types of alarm, and
values of measured parameter.
BIS Module (Optional)
a.
Measured parameters
:
EEG and EMG
b.
Calculated parameters
:
Measure of patient’s level of consciousness
c.
No of channel
:1
d.
Input impedance
: > 10 M
e.
Common mode rejection ratio
:  90 dB
f.
A/D resolution
:  16
g.
Defibrillator Discharge Protection: Tolerates 5000V, 400J
h.
Baseline recovery time
after defibrillation
:1s
i.
Minimum EEG bandwidth
: 0.25 – 70 Hz
j.
Minimum EMG bandwidth
: 70 – 100 Hz
7.
Standard Accessories
7.1
All standard accessories required for the normal operation, shall be listed with itemised prices
and included in the unit base price.
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Contractor’s Authroised Signature and Company Stamp
Annex A –Physiologic Monitor, MRI Compatible
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7.2
The standard accessories shall include the following :
a)
ECG trunk cable with three (3) detachable leads for ECG/respiration x 1 no;
b)
Adult & Child Finger probe for pulse oximetry x 1 each;
c)
Non-invasive pressure cuff for Adult/Child/Large Adult/Infants Cuffs x 1 each;
d)
Mobile Trolley; and
e)
All other essential accessories, attachments and consumables that needed for the full
and safe operation of the unit.
8.
Optional Accessories
8.1
Any other optional accessories and upgrades available with the unit shall be listed separately
with itemised prices.
9.
Installation / Commissioning Requirements
9.1
The Contractor shall inspect the site and fully acquaint himself with the nature of the work and
the local conditions and facilities available, including water, drainage, ventilation and airconditioning, where the Article is to be installed, before submitting his tender. He should also
utilise other means he may prefer or consider necessary in order to fully ascertain other matters,
site accessibility to equipment, conditions or constructions that may have a bearing on, or in any
way affect the preparation of his tender. No claim for extra payment will be entertained by the
Hospital owing to the Contractor’s neglect in this regard and any unforeseen difficulties for which
provision is not made. This will in no way relieve the Contractor from the full execution of all
works necessary to complete the installation. A Contractor, by the fact of submission of a tender,
shall be deemed to have accepted all conditions and stipulations of this clause, which shall be
binding on the Contractor.
9.2
For the testing & commissioning and thereafter for the warranty preventive maintenance &
corrective maintenance or on service contract preventive maintenance & corrective
maintenance, the contractor shall be represented by competent staff, suitably equipped with
all necessary calibrated test and measuring instruments including electrical safety
analyser with printout, who shall test and commission or performing the preventive
maintenance the Articles in the presence of and to the satisfaction of the Company’s authorised
representatives. The Contractor must perform the electrical leakage safety test for the equipment
during commissioning and for every preventive maintenance servicing during warranty
preventive maintenance & corrective maintenance or on service contract preventive
maintenance & corrective maintenance with no cost to the hospital. ( Please refer SCC.3,
Clause 11 for details )
9.3
The testing and commissioning of the Article shall be in accordance with clause 11 of *SCC.3
called under Material Management Department. No payment shall be made if any of the stated
requirements under this clause were not met. Notwithstanding the incomplete acceptance of
the Article, the Company has the right to utilise the Article while waiting for any
incomplete supply , measurements , testing and training to be delivered.
9.4
All mains operated electrical Articles shall be complete with suitably insulated and sheathed
three-core hospital grade flexible power cords of voltage and current rating appropriate to the
Articles. Article for operating theatre shall be supplied with flexible power cords each of not less
than 5m length, although the exact length shall be negotiable later. The flexible power cord shall
be fitted with three-pin, high impact, unbreakable nylon body electrical moulded construction plug
meeting BS 1363/A or equivalent. The plug shall be of good quality consistent with hospital
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Annex A –Physiologic Monitor, MRI Compatible
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safety, moulded construction type and shall be equivalent to “Volex V.1307W”, BICC 3583-07”,
or MK Toughplug”, 13A nylon unbreakable plugs. The plug shall be wired in conformance with
sub-clause 6.5 of IEC 60601-1.
9.5
The successful vendor shall dismantle and remove for disposable the existing old equipment
before installing the new equipment. The cost of disposal of old equipment shall be included in
the tender submission. No claim for extra payment will be entertained by the Hospital owing to
the disposal of old equipment.
10.
Additional Requirements
10.1
The supplied equipment and accessories must be of hospital-grade and shall comply with
national and internationally recognised Standards and applicable Standard Systems.
10.2
The Contractor shall provide test certificates from an internationally recognised testing body
attesting to compliance with recognised standards. * If certificates for the STATED
compliance are not provided during the submission, it shall be considered as noncompliant to the standard.
10.3
The Contractor is expected to successfully commission the Article 14 days from the date of
delivery. Failure of which the Company has the right to return the Article to the Contractor. No
claim for payment will be entertained by the Company. A Contractor, by the fact of submission of
a ender shall be deemed to have accepted all conditions and stipulations of this clause, which
shall be binding on the Contractor.
10.4
The testing and commissioning of the Article shall be in accordance with clause 11 of *SCC.3
called under Material Management Department. No payment shall be made if any of the stated
requirements under this clause were not met. Notwithstanding the incomplete acceptance of the
Article, the Company has the right to utilise the Article while waiting for any incomplete supply to
be delivered.
10.5
The Contractor should be a direct representative/distributor of the manufacturer for all Articles
including accessories.
10.6
The Contractors shall submit a letter of appointment from the manufacturer as sole agent
Singapore for the articles offered. The Contractor shall also specify:
a)
The number of years that they have been appointed agent; and
b)
The expiry date of the current agency agreement;
c)
The expected date of discontinuation of this product.
in
10.7
All mains operated electrical Articles shall be complete with suitably insulated and sheathed
three-core hospital grade flexible power cords of voltage and current rating appropriate to the
Articles. Article for operating theatre shall be supplied with flexible power cords each of not less
than 5m length, although the exact length shall be negotiable later. The flexible power cord shall
be fitted with three-pin, high impact, unbreakable nylon body electrical plug meeting BS 1363/A.
The plug shall be of good quality consistent with hospital safety and shall be equivalent to “Volex
V.1307W”, BICC 3583-07”, or MK Toughplug”, 13A nylon unbreakable plugs. The plug shall be
wired in conformance with sub-clause 6.5 of IEC 60601-1.
10.8
The warranty shall cover unlimited breakdown service calls, calibration and software upgrades,
at no additional cost. The preventive maintenance of the unit shall be in accordance with the
manufacturer's procedure and interval. The regular preventive maintenance shall include testing
in compliance to IEC 60601.1. The Contractor shall at the time of submission, provide a copy of
the preventive maintenance checklist, method and procedures. The Contractor shall provide
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Annex A –Physiologic Monitor, MRI Compatible
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back-up units during the warranty period while the unit is undergoing corrective repair by the
Contractor.
10.9
In the event of equipment breakdown and the downtime exceeds 24 hours, the Contractor shall
be responsible for arranging a loan unit of similar capacity to be used by the Company. All cost
shall be borne by the Contractor.
10.10
The successful Contractor shall provide appropriate In-service training for Physicians, Nurses,
Clinical staff, Laboratory Technologist, etc and Technical Service Training for Biomedical
Engineers/Technicians. A qualified full time trainer shall conduct the training. In-service training
shall be provided by qualified clinical instructors who are not sales personnel. Technical service
training shall be provided by a qualified engineer. The technical service training shall be
comprehensive and provided to a level such that the Company’s nominated service personnel
are able to:
a.
b.
Apply or handle; and
Install, repair, calibrate, maintain or overhaul
all models of equipment purchased from the Contractor. The outline of the Technical service
training programme must include - installation instructions; system overview with block diagram;
detailed theory of operation; detailed preventive maintenance procedures; detailed calibration
and performance checks; detailed trouble shooting; overhaul procedures. Full warranties for all
equipment shall remain in place until at least training for the in-house engineer s has been
completed. Following the completion of training, the Contractor shall, if requested, certify that
trained personnel have completed the Contractor’s training program.
All In-service and technical service training shall be dedicated to the Company and conducted at
the Company’s facilities unless otherwise agreed upon. The Contractor at the point of training
shall provide the Article. All cost shall be borne by the Contractor.
10.11
The Contractor shall submit full details of system, inclusive of a complete list of options
currently available and options that will be available or are currently under development.
10.12
The Company will be entitled to purchase all replacement parts, components, subassemblies
and peripheral devices as needed for the maintenance and repair of each model of equipment
purchased from the successful Contractor at the fair market price. No excessive handling or
shipping charges will be applied to these purchases. The successful Contractor must expedite all
shipments and not withhold shipments in order to increase equipment downtime to the Company
or for any other reasons.
10.13
The Company has the right to use any service representative of his choosing, including in-house,
third party or independent contractor. These representatives have the right to repair, install,
calibrate, maintain or overhaul all models of equipment purchased from the successful Tender.
The Company’s representatives shall be afforded the privilege of ordering all necessary repair
parts and components from the successful Contractor for each model of equipment purchased
at a fair market price.
10.14
The Tender shall guarantee the availability and sale directly to Company or its representative of
spare parts, schematics, parts lists, troubleshooting manuals, operator's instruction manuals,
and all other technical data for the life of the equipment and that replacement of defective parts
or other equipment maintenance by Company or its representative will not affect warranty
conditions.
10.15
The Company has the right to use and operate all hardware and software for the purposes of
operating, repairing, or calibrating the equipment. The Company has the right to allow her
designated service representative to use all software for the repair and calibration of the
equipment purchased.
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Annex A –Physiologic Monitor, MRI Compatible
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10.16
The supply of the system computer must be from a registered computer manufacturer and be
supported by the manufacturer’s service center. The model must fulfill the basic safety
requirements of Radio Frequency Interference, Electromagnetic Immunity and Safety for
Information Technology Equipment. Proof of safety compliance must be presented during the
submission.
10.17
The Company has the right to send her designated service representatives to the manufacturer’s
service training school to receive sufficient, any or all, technical training to allow the
representative to repair and calibrate the equipment purchased.
10.18
All documentation, software and manuals become the sole property of the Company.
10.19
Upon sale or transfer of the equipment purchased within and/or outside of Singapore, the
Company’s shall have the right to transfer any or all hardware, software, documentation and
manuals to the new purchaser of the equipment.
10.20
The Contractor is advice to check for incompleteness and misleading information that may result
in disqualification.
10.21
All Contractors are to comply with all requirements stated in the Company Standard Conditions
of Contract - *SCC.3.
10.22
Failure to comply with any of the above requirements may result in the rejection of the offer.
* SCC.3 is available from Material Management Department.
All Tenderers are to acquaint themselves with the details requirements set out in
SCC.3.
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A.
PERFORMANCE SUMMARY FOR PHYSIOLOGIC MONITOR, MRI COMPATIBLE
Contractor
: _______________________________________________
Name Of Unit/System
:________________________________________________
Manufacture/model
:________________________________________________
Year of manufacture
: _______________________________________________
Year of Model 1st Sold
: _______________________________________________
Country Of Origin
: _______________________________________________
Warranty Period (Min 2 Years)
: _______________________________________________
(The Contractor shall provide a twenty-four (24)-month warranty period, commencing from
date of successful completion of commissioning. The Contractor shall replace all original parts
including rechargeable battery, provide free labour with unlimited breakdown repair calls and
shall also provide regular preventive maintenance as specified in the manufacturer’s latest
technical manuals or operating manuals during the warranty period at no cost to the Company)
(*Please delete where applicable)
Nothing is to be left blank. Where compulsory submissions are required, kindly furnish as
required to avoid disqualification.
A Performance Summary must accompany each option offered.
1.
FULL COMPLIANT with
technical specifications
* Yes/No
2.
NON-COMPLIANT with
technical specifications
pls state nos. only
_____________________
(Details shall be specified
clearly on a separate sheet in text format).
_____________________
_____________________
3.
BASIC MONITORED PARAMETERS (MRI COMPATIBLE)
a.
ECG with ST Segment Analysis
* Yes/No
* Configured/Modular
b.
NIBP
* Yes/No
* Configured/Modular
c.
SpO2
* Yes/No
* Configured/Modular
d.
Respiration
* Yes/No
* Configured/Modular
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Annex A –Physiologic Monitor, MRI Compatible
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4.
OPTIONAL MONITORED PARAMETERS (MRI COMPATIBLE)
a.
3rd Invasive Blood Pressure
* Yes/No
* Configured/Modular
b.
ETCO2
* Yes/No
* Configured/Modular
c.
Neuromuscular Transmission
* Yes/No
* Configured/Modular
d.
ST segment analysis/Arryhthmia option
* Yes/No
* Configured/Modular
e.
Temperature
* Yes/No
* Configured/Modular
5.
OTHER OPTIONAL PARAMETERS AVAILABLE (MRI COMPATIBLE)
i)
BIS
* Yes/No
* Configured/Modular
ii)
Transcultaneous O2
* Yes/No
* Configured/Modular
iii)
Cardiac Output
* Yes/No
* Configured/Modular
iv)
FiO2
* Yes/No
* Configured/Modular
v)
Others
6.
IN-BUILT NETWORKING CAPABILITIES
* Yes/No
7.
DATA TRANSFER CAPABILITY
* Yes/No
8.
ECG
a.
Display
-
b.
pls specify
_______________________
* Configured/Modular
Waveform
Numeric
* Yes/No
* Yes/No
Frequency response,
0.05 to 100 Hz
- monitor
- diagnostic
* Yes/No
pls specify
pls specify
_____________________
_____________________
c.
Common mode rejection ratio
 100 dB
* Yes/No
d.
Baseline drift, mV
* Yes/No
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e.
Lead fault alarm, visual/audio
* Yes/No
f.
Pacer detection and display
* Yes/No
g.
Heart rate display range, BPM
h.
Accuracy,  2%
* Yes/No
i.
Alarm type, visual/audio
* Yes/No
j.
Alarm limits
k.
pls specify
_____________________
high
pls specify
_____________________
low
pls specify
_____________________
Arrhythmia detection and alarm
* Yes/No
pls specify
_____________________
_____________________
l.
Defibrillator discharge
protection
Baseline recovery
pls specify
_____________________
pls specify
_____________________
m.
ESU suppression
pls specify
_____________________
n.
Sensitivity, mm/mV
pls specify
_____________________
o.
QRS indicator
pls specify
_____________________
p.
QRS sensitivity range, mV
pls specify
_____________________
q.
Calibration button
pls specify
_____________________
r.
ST segment analysis
9.
NON-INVASINE BLOOD PRESSURE
a.
Display
Waveform
Numeric
* Yes/No
* Yes/No
Control method
automatic
manual
stat
* Yes/No
* Yes/No
* Yes/No
b.
* Yes/No
c.
Measuring range
pls specify
______________________
d.
Accuracy
pls specify
______________________
e.
Cuff inflation speed
pls specify
______________________
f.
Default cuff pressure
pls specify
______________________
g.
Alarm limit
pls specify
______________________
-
high
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-
low
pls specify
______________________
h.
Maximum measuring time
pls specify
______________________
i.
Safety cuff relief pressure
pls specify
______________________
10.
RESPIRATION
a.
Display
-
Waveform
* Yes/No
-
Numeric
* Yes/No
b.
Bandwidth, Hz
pls specify
______________________
c.
Method of measurement
e.g., impedance, etc
pls specify
______________________
d.
Range, brpm
pls specify
______________________
e.
ECG reject circuit
* Yes/No
f.
Breath indicator
e.g., visual/audible
* Yes/No
g.
Apnea event counter
* Yes/No
h.
Apnea alarm
visual/audible
* Yes/No
i.
Disable
* Yes/No
j.
Disable indicator
* Yes/No
k.
Reset Tone
* Yes/No
11.
PULSE OXIMETER
a.
Display
-
Waveform
* Yes/No
-
Numeric
* Yes/No
b.
Minimum measuring range
c.
Alarm limit range
d.
Response time, sec
pls specify
______________________
high
pls specify
______________________
low
pls specify
______________________
pls specify
______________________
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e.
Averaging time, sec
pls specify
f.
Alarms Probe Disconnect
______________________
* Yes/No
Probe off
* Yes/No
g.
Plethysmogram Display
* Yes/No
h.
Pulse rate
i.
ECG synchronisation
* Yes/No
j.
Capable of measuring dark
skin pigmentation with
accurate results
*Yes/No
12.
INVASIVE BLOOD PRESSURE(OPTIONAL)
a.
Display
pls specify
_____________________
-
Waveform
* Yes/No
-
Numeric
* Yes/No
b.
Measuring range
pls specify
______________________
c.
Accuracy
pls specify
______________________
d.
Zero Balancing range
pls psecify
______________________
e.
Zero Balancing accuracy
pls specify
______________________
f.
Zero Drift
pls specify
______________________
g.
Frequency response, Hz
pls specify
______________________
h.
Alarms
- High
pls specify
______________________
- Low
pls specify
______________________
- Disconnect
* Yes/No
______________________
- Inoperative
* Yes/No
______________________
13.
TEMPERATURE (OPTIONAL)
a.
Minimum measuring range - 0 - 45 C
* Yes/No
b.
Accuracy -  ± 0.1 C
* Yes/No
c.
Alarm limits, adjustable
- High
: 0 - 45 C
* Yes/No
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- low
: 0 - 45 C
14.
ETCO2 (OPTIONAL)
a.
Display
-
Waveform
* Yes/No
-
Numeric
* Yes/No
b.
Minimum measuring range
c.
Interference compensation
N2O
O2
d.
e.
* Yes/No
Atmospheric pressure
pls specify
_____________________
- automatic
* Yes/No
- fixed
* Yes/No
- automatic
* Yes/No
- fixed
* Yes/No
- automatic
* Yes/No
- user settable
* Yes/No
Sensor type
- sidestream/mainstream
pls specify
_____________________
f.
Alarm limits, high/low
pls specify
_____________________
g.
Sampling rate
pls specify
_____________________
h.
Weight if main stream sensor, g
pls specify
_____________________
I
Accuracy
pls specify
_____________________
15.
RECORDER (OPTIONAL)
a.
Type, thermal array
b.
Print function
* Yes/No
-
able to print real-time waveform
* Yes/No
-
numeric
* Yes/No
-
trend.
* Yes/No
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c.
Nos. of channels
-
at least 2 user-selectable waveforms
printed simultaneously.
* Yes/No
d.
Paper speed
* Yes/No
12.5, 25, 50 mm/sec, selectable.
e.
Paper width, 50 mm
* Yes/No
f.
Print resolution, at least 200 dots per inch
* Yes/No
g.
Annotation
-
Bed number,
Patient name,
Date & time of event,
types of alarm, and
values of measured parameter.
* Yes/no
* Yes/No
* Yes/No
* Yes/No
* Yes/No
16.
DISPLAY
a.
Type (color/monochrome)
pls specify
_____________________
b.
Number of traces
pls specify
_____________________
c.
Display resolution
-
type (VGA, etc)
pls specify
_____________________
-
pixels array
pls specify
_____________________
d.
Size, diagonally, cm
pls specify
_____________________
e.
Trace brightness control provided
* Yes/No
f.
Alphanumeric display for all measuring
parameters.
* Yes/No
g.
Freeze function
pls specify
_____________________
h.
Event marker
pls specify
_____________________
i.
Sweep speed, mm/sec
pls specify
_____________________
j.
Trending, hr
pls specify
_____________________
k.
Trending parameters
pls specify
_____________________
l.
Displayed parameters
pls specify
_____________________
m.
Alarm, audio/visual
pls specify
_____________________
n.
Default alarm, customisable
pls specify
_____________________
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17.
NEUROMUSCULAR TRANSMISSION (OPTIONAL)
a.
Current range
pls specify
_______________________
b.
Pulse width
pls specify
_______________________
c.
Pulse repetition
pls specify
_______________________
d.
Train Of Four repetition
interval
pls specify
_______________________
e.
Tetanus stimulation
*Yes/No
f.
Capability of plexus location
and stimulation
*Yes/No
h.
Choice of surface or needle electrodes preferred
*Yes/No
18.
BIS MODULE (OPTIONAL)
a.
Measured parameters
pls specify
_____________________
b.
Calculated parameters
pls specify
_____________________
c.
No of channel
pls specify
_____________________
d.
Input impedance
pls specify
_____________________
e.
Common mode rejection ratio
pls specify
_____________________
f.
A/D resolution
pls specify
_____________________
g.
Defibrillator Discharge Protection pls specify
h.
Baseline recovery time
after defibrillation
pls specify
_____________________
i.
Minimum EEG bandwidth
pls specify
_____________________
j.
Minimum EMG bandwidth
pls specify
_____________________
19.
SYSTEM NOISE LEVEL, dBA
when in full operation
pls specify
_______________________
20.
POWER CORD/PLUG
a.
Safety catch for securing the line power
cord (casing interface) to the unit casing
b.
Type of power moulded construction plug use,
* Configured/Modular
_____________________
* Yes/No
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e,g.,single phase 13A, 20A,etc
pls specify
_______________________
21.
FUSEHOLDER (if applicable)
a.
Accessible from outer chassis
b.
Others
22.
FLUID-SPILL PROOF
a.
Degree of protection - IP code
pls specify
_______________________
23.
OVERALL SIZE, H,W,D, cm
pls specify
_______________________
* Yes/No
pls specify
_______________________
* Yes/No
Provide a breakdown for each piece
of apparatus if it is not an integrated system.
_______________________
_______________________
_______________________
24.
OVERALL WEIGHT, kg
pls specify
Provide a breakdown for each piece
of apparatus if it is not an integrated system.
_______________________
_______________________
_______________________
_______________________
25.
BATTERY OPERATED (if applicable)
a.
Battery type
pls specify
______________________
b.
Battery rating
pls specify
______________________
c.
Full charging time
pls specify
______________________
d.
Battery operating time, hr
pls specify
______________________
e.
Built-in charger
26.
ELECTRICAL SAFETY
a.
Safety Class
pls specify
* I / II / III
b.
Type of protection
pls specify
* B / BF / CF
c.
Insulation resistance, Meg ohms
(between active/neutral and earth
accessible metal parts)
pls specify
* Yes/No
______________________
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d.
Protected from transient power
disruptions during use
e.
Protective ground, ohms
f.
Earth leakage current, A
g.
* Yes/No
pls specify
_____________________
- no fault condition
pls specify
_____________________
- neutral open
pls specify
_____________________
- no fault condition
pls specify
_____________________
- neutral open condition
pls specify
_____________________
- ground open condition
pls specify
_____________________
Enclosure leakage current, A
27.
POWER CONSUMPTION
a.
Standby Operation, KVA/KW/Amp
pls specify
_____________________
b.
Normal Operation, KVA/KW/Amp
pls specify
_____________________
c.
Heat Dissipation
Equipment
Maximum Heat –
Standby Operation
Model
pls specify
Maximum Heat –
Normal Operation
28.
STANDARDS OF COMPLIANCE
(certificate of conformity to be provided)
_____________________
a.
Can your proposed system comply to International
standards such as International Electrotechnical
Commission (IEC), British Standards (BS),
European Standard (EN), etc?
*Yes/No
b.
Kindly specify the type of compliance and its class.
_____________________
c.
Can your proposed system comply to these standards.
A certificate for each compliance is required (previous
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compliance for the same model may be accepted
as a reference) for submission.
i)
IEC/EN 60601-1 General safety requirements for
Electrical Medical Equipment
* Yes/No
ii)
IEC/EN 61000-4-X series Electromagnetic Compatibility
-Immunity or equivalent.
* Yes/No
iii)
IEC/EN 60601-1-2, Safety requirements for Electromagnetic
Compatibility-Emisssion or equivalent
* Yes/No
iv)
IEC/EN 60601-2-25, Particular requirements for the safety
of electrocardiographs;
* Yes/No
v)
IEC/EN 60601-2-27, Particular requirements for the safety
of electrocardiographic monitoring equipment;
* Yes/No
vi)
ANSI/AAMI EC 11 (1982) - requirements for
Diagnostic Electrocardiograph Devices.
* Yes/No
vii)
IEC/EN 60529 (1989), Degrees of protection
provided by enclosures (IP code).
* Yes/No
- IP code
pls specify
_________________________
viii)
International available standards in the particular
requirements for safety and performance
for the tendered Article;
* Yes/No
ix)
IEEE 1073, Medical Information Bus (MIB) -
* Yes/No
x)
Software validation by FDA;
* Yes/No
xi)
FDA system clearance.
* Yes/No
xiii)
Others (pls specify)
______________________
* If certificates for the compliance are not provided during the submission, it shall be considered
as non-compliance to the standard.
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29.
WARRANTY & POST-WARRANTY SERVICE CONTRACT (p/s submit with each offer)
Description
Warranty
Period
1st year after
warranty
2nd year
after warranty
3rd year after
warranty
Frequency of
Preventive maintenance
(nos. of times per
year) recommended by
manufacturer : _______
(Note : Vendor must
submit confirmation
documents from
manufacturer.)
Frequency of
Preventive maintenance
(nos. of times per
year)
Hospital Requirement
:Frequency of
PM during warranty : 2
times or more per year
Annual Charges for
Preventive
Maintenance(PM)
only.
(The cost which covers all
labour and transportation
cost of providing PM only
periodically within a year
and
corrective
maintenance
is
not
included)
Not
Applicable
Not
Applicable
Not
Applicable
Not
Applicable
Not
Applicable
$
$
$
Annual Charges for
Preventive
Maintenance(PM)
And unlimited Breakdown
Repair calls (The cost
which covers all labours
transportation,
on-site
response for providing
both PM and corrective
maintenance
except
replacement parts )
Annual Charges for
Preventive
Maintenance(PM)
And unlimited
Breakdown
Repair calls and all
Replacements parts
Including software
upgrades, etc. (The cost
for
comprehensive
maintenance which covers
all labours, transportation,
Not
Applicable
$
$
$
Not
Applicable
$
$
$
Frequency of
PM : ______
During Warranty
Period /per year
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on-site
response
for
providing both PM and
corrective
maintenance
and parts
including software
upgrades, etc.)
30.
SERVICE SUPPORT
a.
Does your service support, irrespective of
contracted service or warranty repair covers
after office hours i.e. after 5.30 pm and
weekends ?
* Yes/No
i)
After office hours
* Yes/No
ii)
During weekend
* Yes/No
iii)
Labour charge for non contract service during office hour $_________________/hr
iv)
Labour charge for non contract service after office hours
$_________________/hr
v)
Labour charge for non contract service during weekend
$_________________/hr
* Please attach operating hours for service support for our information. And provide
Sales and Service organisation chart for emergency contract.
b.
What percentage of essential spare part support are you
stocking to meet TTSH repair/service needs?
i)
percentage of stock essential spare parts relative to
total essential spare parts.
__________ %
ii)
cost of stocked items
$__________
* Full list of essential spare parts is required. Kindly indicate those that you would be
stocking. Non-stock parts would still be reflected in the full list.
iii)
c.
percentage of stocked essential spare parts relative to the
whole system (i.e. all the parts that make up the system)
Please list the TOP 5 most expensive spare part for this unit.
Part No.
d.
__________ %
Description
Cost (SGD)
If parts are to be delivered from overseas, kindly state the
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turnaround time for delivery to TTSH
i)
Standard delivery
___________days
ii)
Courier delivery
___________days
iii)
Air Parcel
___________days
iv)
Others
___________days
e.
Number of years spare part will continue to be available
after the discontinuation of the model purchased by TTSH
_____________
f.
Frequency of PM (times/year) during warranty period
g.
24-hours service available
h.
Service response time (hours)
________________________
i.
Maximum down time
________________________
j.
Are your Service Engineer trained on the
proposed system?
________________________
* Yes/No
* Yes/No
- Name of trained personnel
pls specify
_______________________
- Designation
pls specify
_______________________
- Educational qualification
pls specify
_______________________
- Contact No/pager
for backup services
pls specify
_______________________
- Years of service with
the employer
pls specify
_______________________
- Factory Trained
pls specify
_______________________
_______________________
_______________________
( If you are not factory trained, please give details of your supervisor or colleague who
trained you and supervise your work. )
- Last Training date
pls specify
- Next Re-certification date
_______________________
pls specify
_______________________
k.
Is replacement unit available?
* Yes/No
l.
Can replacement unit be made available within
24 hours upon request during warranty period?
* Yes/No
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m.
Is the loaner unit available without charges
for equipment under repair and awaiting
for spare parts during and after warranty period ?
* Yes/No
If there is charges, what are the charges? ______________________________
______________________________
______________________________
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n.
S/N
Spare Part list (Stocked and Non-stocked items) valid for two (2) years after warranty
Description
Unit Price
Stock
Item
Y/N
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31.
TRAINING
a.
Does your In-service training cover:
- equipment operation
* Yes/No
- general maintenance
* Yes/No
- equipment safety verification
(for use on patients)
* Yes/No
- others
pls specify
_____________________
_____________________
b.
Does your technical training cover:
- installation instructions
* Yes/No
- system overview with block diagram
* Yes/No
- detailed theory of operation
* Yes/No
- detailed preventive maintenance procedures
* Yes/No
- detailed calibration and performance checks
* Yes/No
- detailed trouble shooting
* Yes/No
- overhaul procedures
* Yes/No
- others
pls specify
_______________________
c.
Estimated date for technical training
to commence after the delivery
of the unit/system.
pls specify
_______________________
d.
Trainer’s Credentials
-
Name of Trainer
pls specify
_______________________
-
Designation
pls specify
_______________________
-
Educational qualification
pls specify
_______________________
-
Contact No/pager
for backup services
pls specify
_______________________
-
Years of service with
the employer
pls specify
_______________________
-
Trained by Manufacturer to
service product
(Pls submit certificates)
* Yes/No
____________________________________________________________
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-
Certified by manufacturer to
provide technical training
(Pls submit certificates)
-
Date of last technical training
received for this product
* Yes/No
pls specify
________________________
____________________________________________________________
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e.
S/N
Training Program
Contents
Duration
____________________________________________________________
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32.
AVAILABILITY OF EVALUATION UNIT
* Yes/No
33.
AVAILABILITY OF SERVICE MANUALS
* Yes/No
(2 X DVD/CD of operating/service manual in soft copy for Biomedical Engineering)
34.
DO YOUR COMPANY OWN A ELECTRICAL SAFETY ANALYSER?
*Yes/No
If yes, please specify the Brand: ____________ & Model:_____________
35.
OTHER FEATURES
pls specify
_______________________
_______________________
_______________________
36.
S/N
REFERENCES
Year
Purchased
Institution
Contact
Person/Number
I hereby certify that all information are true and correct and shall fully comply with all requirements stated in
this specifications, unless stated otherwise under the Statement of Non-compliance.
____________________________________________________________________
Signature & Stamp/Seal of the Contractor
____________________________________________________________________
Name/Designation/Contact Number
Date
** Please note that full information shall be provided before the closing date. Insufficient
information will not be accepted.
All information must be provided to avoid rejection of offer.
Every page of the Technical & Performance summary must be duly signed, company stamp and
return with the submission.
____________________________________________________________
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ANNEX A-1
COMPLIANCE TO REQUIREMENTS/SPECIFICATION
Please specify in the format below all areas of non-compliance. Failure to use this format may
render the Tender submission liable to rejection. KINDLY REPRODUCE ADDITIONAL COPIES
AS NECESSARY.
Requirements/
Specification
Clause No.
Full Details of Non-Compliance
____________________________________________________________
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ANNEX A-2
1.
CONTRACTOR CHECKLIST for
SUBMISSION OF DOCUMENTS
CONFORMITY CERTIFICATES
IMPORTANT: Please insert the required certificates after this page. (Mandatory)
a.
IEC/EN 60601-1/ IEC/EN 61010-1
* Yes/No
b.
IEC/EN 61000-4-x series or equivalent
EMC compliance
* Yes/No
c.
IEC/EN 60601-1-2 or equivalent
EMC compliance
* Yes/No
d.
Particular requirements for the safety
and performance for the tendered Article
* Yes/No
e.
Other related
__________________
__________________
2.
FDA CLEARANCE
a.
Pre-market notification (510K)
* Yes/No
b.
Pre-market approval (PMA)
* Yes/No
3.
MANUFACTURER’S LETTER
a.
Distributor appointment letter
* Yes/No
b.
Frequency of preventive maintenance
per year recommended by manufacturer
* Yes/No
4.
PREVENTIVE MAINTENANCE (PM)
a.
Checklist
* Yes/No
b.
Procedure for carrying out PM
* Yes/No
5.
SPARE PART PRICE LIST
a.
Full list with price valid for 2 years
* Yes/No
b.
Stocked spare parts
* Yes/No
____________________________________________________________
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6.
TRAINING PROGRAMME
a.
Detailed Technical training indicating
the number of days and the time
required for each segment of the training.
* Yes/No
b.
Operator
* Yes/No
7.
REFERENCE LIST
a.
Telephone no/contact person
* Yes/No
b.
Year in which they were supplied
__________________
__________________
8.
PERFORMANCE SUMMARY
a.
Fully completed
* Yes/No
(Performance summary is INCOMPLETE without the SUBMISSION of documents!)
9.
ORGANISATION CHART
* Yes/No
10.
CERTIFICATES OF TECHNICAL
SERVICE ENGINEERS
* Yes/No
11.
OTHERS
_______________________________________________________________________________
_______________________________________________________________________________
____________________________________________________________
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Contractor’s Authorised Signature and Company Stamp