dimensionless-诸葛弩
Usability File
MLD 9.05e
BS EN 62366:2008
Documentation of Compliance
Product Description
Product
Series
Issue:
Date:
Signed:
Bubble Humidifier
ACME001
1
18.3.10
J Bloggs
MLD
9.05e
Standard reference: BS EN
62366:2008
1
1.1
1.1.1
Inputs to the USABILITY SPECIFICATION
Specification of the INTENDED
USE/INTENDED PURPOSE
Description
The ACME Bubble Humidifier has been
design specifically to be used with Oxygen. The
unit can
be used in most types of
medical environments such as Hospital, Medical
Centres, Ambulances
and Domestic
purposes.
The humidifier works by
conducting gas down the small internal tube that
is submerged in water.
The gas passes
through the diffuser (sintered metal), which
breaks the gas into small bubbles,
increasing the surface area. The
bubbles float passively to the surface, absorbing
water vapour.
The humidified gas then
flows out through the outlet. The bottle component
is moulded in
autoclavable HDPE.
The Humidifier has been designed to
connect to Flowmetering Devices via a 9/16
Connector and
that can provide a flow
rates from 2 to 6 Lpm with a backpressure of 4
bar.
EQUIPMENT application
specification
To humidify the medical
gas flow (Oxygen) to a patient e.g. via attached
tubing and facemask.
Age: newborn to
geriatric
Weight: > 2.5 kg
Health: not relevant
Nationality: multiple
PATIENT state:
- PATIENT is
not the OPERATOR
No direct contact with
the patient
–
though
attached tubing and facemask would contact nose
and mouth.
Trained medical
or paramedical staff who understand how to connect
to a flowmeter and the use
of
humidified oxygen.
Environment
General:
-
-
-
-
-
-
-
-
-
-
-
Hospital
Care Home/Hospice
Ambulance
Could be damaged
by impact e.g. dropping or collision, then not
function.
When functioning is shall
keep humidifying the oxygen..
Ambient
luminance 100
–
500 lux
Viewing distance 20 cm to 1 metre
Viewing angle: normal to the scale
±
20°
Working
pressure 400 kPa
Operation range 2 to 6
Lpm recommended
Permitted leakage -
zero
2
1.1.2
a)
b)
c)
d)
e)
1.1.2.1
Medical purpose
1.1.2.2
PATIENT population
1.1.2.3
Part of body or type
of tissue applied to or interacted with
1.1.2.4
Intended
OPERATOR
1.1.2.5
Application
a)
Conditions of visibility:
Physical:
-
Normal ambient conditions
apply.
b)
Frequency of use:
-
Once a year up
to 10+ times a day
c)
Mobility:
-
Intended to be fixed to gas supply,
which could be on a mobile trolley.
1.2
PRIMARY OPERATING FUNCTION
1.2.1
Frequently used
functions
a)
Filling with
water
b)
Reading scale
c)
Attaching to/removing
from gas supply/flowmeter
d)
Attaching to patient tubing/facemask.
e)
Cleaning
–
can be sterilised
f)
Storing
1.2.2
Functions related to SAFETY
a)
Reading scale
–
especially when water
supply exhausted
b)
Supplying correct flow for
condition/patient
c)
Cleaning
d)
Servicing & maintenance
1.3
Risk analysis
1.3.1
INTENDED USE/INTENDED
PURPOSE
See 1.1
1.3.2
USER PROFILE
See 1.1.2.4
1.3.3
Things That could go wrong
Sources: Literature, Device Alerts,
Sales, Healthcare Staff, Risk Analysis etc
a)
During normal use:
-
Water has
run out →
level not visible
b)
Use Errors:
-
Not refilling
-
Applying excessive
force/mechanical stress/tampering
-
Dropping/Impact
-
Blockage
-
Leakage
c)
Environment:
-
Explosion when exposed to
ignition source
d)
Patient:
-
Tampering
e)
Reading:
-
Not reading water level
correctly
f)
Hygiene:
-
Cross-
contamination
3