IEC 62366-可用性报告范例-Humidifier

Usability File MLD 9.05e

BS EN 62366:2008

Documentation of Compliance

1 Inputs to the USABILITY SPECIFICATION

1.1 Specification of the INTENDED USE/INTENDED PURPOSE

1.1.1 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.

1.1.2 EQUIPMENT application specification

1.1.

2.1 Medical purpose

To humidify the medical gas flow (Oxygen) to a patient e.g. via attached tubing and facemask.

1.1.

2.2 PATIENT population

a) Age: newborn to geriatric

b) Weight: > 2.5 kg

c) Health: not relevant

d) Nationality: multiple

e) PATIENT state:

- PATIENT is not the OPERATOR

1.1.

2.3 Part of body or type of tissue applied to or interacted with

No direct contact with the patient – though attached tubing and facemask would contact nose

and mouth.

1.1.

2.4 Intended OPERATOR

Trained medical or paramedical staff who understand how to connect to a flowmeter and the use of humidified oxygen.

1.1.

2.5 Application

a) 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..

Conditions of visibility:

- Ambient luminance 100 – 500 lux

- Viewing distance 20 cm to 1 metre

- Viewing angle: normal to the scale ± 20°

Physical:

- Working pressure 400 kPa

- Operation range 2 to 6 Lpm recommended

- Permitted leakage - zero

- 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

1.3.4 Task requirements

a) Clearly recognisable instructions on bottle

b) Easily assembled/disassembled

c) Readable/legible scale

d) Easy cleaning of device

e) Light-weight design

f) Easy to service & maintain

1.3.5 The context of use

See 1.1.2.5

1.3.6 Information on HAZARDS known for existing device

Included in 1.3.3

1.3.7 Resulting HAZARDOUS SITUATIONS and HARMS

a) No humidification → improper treatment

b) Too much O2 administered over time – i.e. no CO2 content for breathing response

c) Ineffective therapy e.g. for COPD if Air rather than O2 administered/Hypoxia

d) Introducing contaminants to the body

e) Used with patients whose supraglottic airways have been bypassed

1.3.8 Preliminary review of the USER INTERFACE concept

Note: This review could be conducted utilizing a combination of cognitive walkthroughs, mock-up testing and early prototype testing.

a) Connection into appropriate oxygen flowmeter:

- Flowmeters labelled & body/knob colour coded (black – AIR; White – Oxygen) Conclusion: No issues

b) Connecting patient tubing/face mask from flowmeter:

- Could supply Air to patient rather than Oxygen or vice versa

- Operating outside recommended flow rate

Conclusion: Training issue

c) Preparing use:

- Easy to assemble/disassemble

- Filling to maximum level with water

- Detailed operating function in instructions

Conclusion: no issues

d) Reading display:

- Font and lines clearly legible

- Instructions on bottle)

Conclusion: no issues

e) Cleaning:

- Can be autoclaved

- Easy visual identification of contaminated surfaces

- Surface finishes smooth

Conclusion: no issues

f) Removing from gas source/flowmeter

- Requires unscrewing from flowmeter

- Straight forward procedure

Conclusion: no issues

2 USABILITY SPECIFICATION

2.1 General

a) MEDICAL DEVICE

Bubble Humidifier – H110

b) Basis:

- Intended use, see 1.1

- Possible use errors, see 1.3.3

- Hazardous situations or harms related to use, see 1.3.7

- Context of use

o Patient attaches/un-attaches facemask connected to gas source –

flowmeter/humidifier assembly

- Preliminary use scenarios

o Patient searches for facemask/tubing connected to flowmeter/humidifier

assembly by bed Terminal Unit (TU)

o Operates attached flowmeter independently

2.2 USE SCENARIOS

Worst case scenarios to provide a basis for validation with patient = user

a) Breathing humidified oxygen in bed:

- user/patient = adult

- alone in room, not supervised

- lying in bed or in chair by bed

- operates flowmeter control knob

- breathes through attached facemask/tubing

- pulls out nasal cannula

- ignition source/materials

- allows water to run out

2.3 USER actions related to PRIMARY OPERATING FUNCTIONS

a) Turning attached flowmeter on/off

b) Placing connected facemask correctly over nose/mouth or cannula in nose

c) Observes water level – reading result

d) Cleaning device after use

e) Arranging servicing as necessary (PPM)

f) Removing device from gas source/flowmeter

g) Storing device correctly when removed (stores/EBME)

2.4 USER INTERFACE requirements for the PRIMARY OPERATING FUNCTIONS

a) Connection to gas source/flowmeter:

- easy connection to flowmeter with one hand

- indication on bottle instructions (label) not to use with patients whose supraglottic airways have been bypassed

b) Filling with water

- easy to fill

c) Reading display:

- scale and bobbin clearly visible under conditions of visibility, see 1.1.2.5

- minimum and maximum level indicated

- text on bottle for correct flow rate

d) Surface and material:

- body impact strength 80 kJ/m2 (Notched Charpy)

- smooth surfaces for easy cleaning

e) Holding part:

- bottle height 104mm

- bottle width 76mm

f) Measuring part:

- smooth translucent surface – water level easily visible

g) Cleaning:

- can be autoclaved

- smooth surfaces for easy access

h) Storage:

- should be kept in clean plastic bag (as supplied)

i) Accompanying Document – issues to be addressed:

- no leakage allowed

- no grease or oil to be used

- not to be exposed to naked flames or radiant heat source

- fill with water to maximum level before connecting to gas supply/flowmeter

- do not use if damaged

- always carry out Inspection prior to use

2.5 USER INTERFACE requirements for those USE SCENARIOS that are most frequent or

related to SAFETY

a) The whole setting and measurement procedure shall be easy to do after reading the

accompanying document

- connecting to flowmeter

- filling to correct level

- reading water level scale

- setting attached flowmeter to correct flow rate

- cleaning the device after use

b) Text: English

c) Font size 8 pt Arial minimum

d) Symbols to be intuitive for intended users

2.6 Requirements for determining whether PRIMARY OPERATING FUNCTIONS are easily

recognisable by USER

a) Placing device in correct flowmeter:

- no additional requirements

b) Filling:

- easy to see scale/level

c) Reading scale:

- no additional requirements

d) Cleaning:

- no additional requirements

e) Turning off:

- no additional requirements

f) Removing device from gas source/flowmeter

- no additional requirements

g) Storing:

- no additional requirements