4.

Notes,
1. 5. Evaluation
2. 3. remarks,
numb committee’s
Specifications required Specifications offered ref to
er notes
documentati
on
19. Pulse Oximetry
NAME, CODE, CATEGORIES AND DEFINITION
1 Generic Name Pulse Oximeter.
2 Ethiopian MDN Pulse Oximeter.
3 European Pulse Oximeter.
MDN
4 Code # Z1203020408.
Alternative
5 Name (If Pulse Oximeter Battery Powered.
there
is)
Medical Equipment and Related Accessories,
5 Categories
Software and Consumables.
Keyword
6 SpO2, Oxygen, Monitor, Portable.
s
(optional
)
PURPOSE OF USE
Clinical To monitor the haemoglobin oxygen saturation of
1
Purpos patient, diagnosis for respiratory disorder.
e
2 Patient Type All
Speciality
3 For All selected Specialty.
Departme
nt
Displays patient oxygen saturation and pulse
rate in real time using an external probe on the
Overview skin.
4 of Display and probe built into one case.
Functional Intended for time-limited spot checks, so alarm
requireme features not required.
nt Operates from internal battery (locally available
type, rechargeable or non-rechargeable.)
 4.
Notes,
1. 5. Evaluation
2. 3. remarks,
numb committee’s
Specifications required Specifications offered ref to
er notes
documentati
on
TECHNICAL CHARACTERISTICS
SpO2 measurement range at least 70 to 99 %,
minimum resolution 1%.
Accuracy of SpO2 better than ± 2%.
Pulse rate range at least 30 to 240 bpm,
minimum gradation 1 bpm.
Accuracy of pulse rate better than ± 4 bpm.
Detailed Signal strength or quality to be visually displayed.
1 Automatic power-off facility required after
Requireme
nt minimum of 1 minute
Low battery display required.
Facility for data download preferred.
Digital equipment with autocorrelation algorithm.
Internal memory continuous data storage time not
less than 12 hours.
Integrated display for data visualization with size
not less than 5 inches.
Video display of at least the following parameters:
 SpO2 sensor connected.
 Alarms disabled.
 Low battery.
Display  Battery in charge.
2
Parameter
Plethysmography curves and tendency lines
s
visualization capabilities for monitored
parameters.
At least the following audio alarms:
 High frequency.
 Low frequency.
 Low saturation.
User
3 Optional.
Adjustable
Setting
 4.
Notes,
1. 5. Evaluation
2. 3. remarks,
numb committee’s
Specifications required Specifications offered ref to
er notes
documentati
on
PHYSICAL/CHEMICAL CHARACTERISTICS
Case is to be hard and splashproof.
Display must allow easy viewing in all ambient light
1 Components levels.
Supplied in protective case for clean storage
and safe transport.
Handlebar or facilities for easy transportation.
Mobility
2 N/A.
(if
relevant)
Raw
3 N/A.
Materials (if
relevant)
UTILITY REQUIREMENTS
Electric power supply for adapter: 220V AC, 50 Hz,
±10%.
Electrical, Plug should be schuko type.
Water and Battery powered alarm in the event of power
1
(Gas supply if failure, with temporary silence feature.
relevant) Voltage corrector / stabilizer to allow operation at
± 30% of local rated voltage.
Electrical protection by resettable overcurrent
breakers or replaceable fuses, fitted in both live
and neutral lines.
ACCESSORIES, CONSUMABLES, SPARE PARTS, OTHER
COMPONENTS
Battery charger, Batteries.
Oximeter cable with a length of at least 1 m.
1 Accessories 1 adult patient reusable oximeter sensor.
1 paediatric patient reusable oximeter sensor.
1 neonatal patient reusable oximeter sensor.
 Sterilization
2 N/A.
Processes
for
 4.
Notes,
1. 5. Evaluation
2. 3. remarks,
numb committee’s
Specifications required Specifications offered ref to
er notes
documentati
on
Accessories (if
relevant)
Consumables
3 and N/A.
Reagents (if
relevant)
4 Spare Parts Optional.
Other
5 Components Optional.
(if relevant)
PACKAGING
Sterility
1 Status on N/A.
Delivery (if
relevant)
Shelf Life
2 N/A.
(if
relevant)
Transportation
3 and Storage N/A.
(if relevant)
Labelling
4 N/A.
(if
relevant)
ENVIRONMENTAL REQUIREMENTS
Context Capable of being stored continuously in ambient
1 Depende temperature of 10 to 32 °C and relative humidity
nt of 15 to
Requirements 90%.
TRAINING, INSTALLATION AND UTILISATION
Pre-
1 Installation N/A.
Requirement
(if relevant)
 4.
Notes,
1. 5. Evaluation
2. 3. remarks,
numb committee’s
Specifications required Specifications offered ref to
er notes
documentati
on
Requirement
2 for Local clinical staff to affirm completion of
Commissioni installation.
ng
Training for Training of users in operation and basic
End Users maintenance shall be provided.
3
and Technical
Advanced maintenance tasks required shall be
Personal
documented.
User Care
4 The case is to be cleanable with alcohol or chlorine
(if
wipes.
relevant)
WARRANTY AND MAINTENANCE
1 Warranty N/A.
Maintenan
2 N/A.
ce Task
Type of
3 N/A.
service
contract
Spare Parts
4 Available N/A.
Post
Warranty
Software
and
5 N/A.
Hardware
Upgrade
Availability
DOCUMENTATION
Operational, technical and maintenance
manuals to be supplied in English language.
 List to be provided of important spares and
Documentati accessories, with their part numbers.
1
on Contact details of manufacturer, supplier and local
Requirement service agent to be provided.
s