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REGISTRO DE REVISÕES
REV. DATE PROJ BRIEF DESCRIPTION OF REVIEW
A 17-10-2007 ANES Initial Issue
CRITICAL ANALYSIS
EXECUTED BY: APPROVED BY: APPROVED BY (OPTIONAL) APPROVED BY (OPTIONAL)
Function Development Engineer
Date
Name Taciana Tonetto Castelo Branco
Initials TTCB
VERIFICATION PLAN
GOAL
<>
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VERIFICATION PLAN OF HOSING TO DX 5010 VL50133A
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REFERENCES
MATERIAL
<Describe materials, equipment and tools necessary for the verification performance>
OBSERVATIONS
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PLANNING
Reference Reference
Item (Standard or Description (Risk Acceptance Criterion Expected Result
Specification) Analysis)
Guidelines for
Specification Review of component checking components
Check if all mechanical parts are oil, grease and cavaco free.
MC 1 guidelines are OK for this
criterion.
Guidelines for
Specification Check if all mechanical parts are corner free and with no Review of component checking components
MC 2 cutting edges. guidelines are OK for this
criterion.
Specification Check if gas inlet peaks are in accordance to the regulation: Review of inspection
FEQ related OK.
MC 4 Air: 3/8”W, O2: ½” UNF and N2O: M12x1.75. documents
Specification Check the presence of water filter at the compressed air inlet
Visual Presence of filter.
MC 8 of the anesthesia equipment.
All o’rings of the high-
Specification Verification of product
Check if all o’rings of the high-pressure system are in Viton. pressure system are
MC 11 structure
in Viton.
Check if, internally to the Fresh Gas system, the pipe sizes
follow this standard::
Oxygen: Ø6 external and Ø4 internal The pipes of the fresh
Specification
Air: Ø8 external and Ø6 internal Visual gas system are
MC 22
N2O: Ø4 external and Ø3 internal standardized
Check with the pneumatic diagram of the DX 5010
equipment.
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NBRIEC60601-1
6.1 e) f)
IEC 60601-1 Check if there is a equipment model mark, name/trademark
Visual The mark is present.
7.2.2 of the manufacturer (DX 5010, DIXTAL)
IEC 60601-2-13
6.1. aa)
IEC 60601-1 Check if the symbol “refer to attached documentation” is next
Visual The mark is present
7.2.3to the plugs and the information on the spare cylinder
NBRIEC60601-1 Check if there is a mark for the inlet voltage range (100-
6.1 g) 240V), type of current (alternate, indicated by the electrical Visual The mark is present
IEC 60601-1
7.2.5 power frequency– 50/60Hz), class I symbol.
NBRIEC60601-1
6.1 h) j)
Check if there is a mark for the current used in A or power in
IEC 60601-1 Visual The mark is present
VA or W. (10A)
7.2.7
NBRIEC60601-1
6.1 k) p) Check if the aid plugs are marked with the Attention and the
IEC 60601-1 Maximum outlet symbols in A. [1A for plugs next to the
source, 3.15A for the plug dedicated to the monitor]. Visual The mark is present.
7.2.8.1
IEC 60601-2-13
6.1. k)
NBRIEC60601-1
6.1 l)
Check if there is the IPX1 classification mark. Visual The mark is present.
IEC 60601-1
7.2.9
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NBRIEC60601-1
6.1 l)
Check if there is a mark for the type B applied part. Visual The mark is present.
IEC 60601-1
7.2.10
NBRIEC60601-1
6.1 n) Check if by the side of the fuses accessible to the operator
Visual The mark is present.
IEC 60601-1 there is a mark with its technical features (type, voltage).
7.2.12
IEC 60601-1 Check if the gas inlet maximum pressure is marked next to
Visual The mark is present.
7.2.18 the connectors (6bar).
NBRIEC60601-1
6.1 y) Check if the ground functional terminal is identified by its
Visual The mark is present.
IEC 60601-1 symbol.
7.2.19
NBR IEC
Check if, internally, at the battery side, there is a mark related
60601-1 Visual The mark is present.
to “attention” and “check attached documentation”.
6.2 d)
NBR IEC
60601-1
6.3 a) Check if the on/off knob (general key) presents the symbols Visual The mark is present.
IEC 60601-1 I-on, 0-off.
7.4.1
NBR IEC
Check if the position of these controls is well identified: Air- Positions well
60601-1 Visual
N2O selection key, bag selection key – ventilator, APL valve. identified.
6.3 a)
NBR IEC
The knobs are clearly
60601-1 Check if the alarm knob and its silencer are clearly identified. Visual
identified.
6.3 f)
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Check if the specific gas inlets and outlets are identified with
the gas name or chemical symbol, besides the feeding
pressure range declared in SI. Specifically:
NBR - Air inlet: 300 to 600kPa;
IEC 60601-2-13 - Oxygen inlet: 300 to 600kPa; Visual The mark is present.
6.1. aa) - Nitrous Oxide inlet: 300 to 600kPa;
- Oxygen cylinder inlet: 7000 to 14700kPa;
- Air outlet to Aspirator: 300 to 600kPa;
- Oxygen outlet to Aid Flowmeter: 300 to 600kPa.
NBR Check if there is a mark on the oxygen flow and anesthetic
IEC 60601-2-13 steam condition when there is interruption in the gas net Visual The mark is present.
6.1. aa) supply.
NBR
IEC 60601-2-13 Check the mark for fresh gas flow outlet (FGF). Visual The mark is present.
6.1. aa)
NBR
Check if the mark for maximum inlet power declared includes
IEC 60601-2-13 Visual The mark is present.
the power of the aid power net plugs. (2400VA)
6.1 j)
NBR
Check the presence of a label with information on the
IEC 60601-2-13 Visual The mark is present.
equipment checking.
110
ISO 8835-2 Check if it is possible to observe the change in the soda lime The change in color is
Visual
7.1.1 color through the absorbent reservoir visible.
The operation is
ISO 8835-2 The operator may visualize the functioning of inspiratory and
Visual visible by the
7.6.1 expiratory unidirectional valves.
operator.
ISO 8835-2 Check if the manometer scale of the airway pressure ranges Scale and unit are in
Visual
8.1.2 from -10cmH2O to120cmH2O. accordance.
ISO 8835-2
Check the “exhaustion” mark of the APL outlet. Visual The mark is present.
10.1.2 d)
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ISO 8835-2
Check the “bag” mark in the reservoir bag connection. Visual The mark is present.
10.1.2. e)
Back part of the equipment: check in the bellows outlet to the
ISO 8835-2
circle filter the “to circle filter” mark, and in the doc-station the Visual The mark is present.
10.1.2 f)
“to ventilator” mark.
ISO 8835-2 Check in the bag-ventilator valve the respective words
Visual The mark is present.
10.1.2 h) indicating position.
INBR
Check if it is only possible to activate the off knob with an Non-intentional
EC 60601-2-13 Mechanical
intentional movement. activation is impeded.
49.101.1
NBR IEC It is possible to place
Check if it is possible to place the power net plug in any aid
60601-2-13 Visual the power plug in the
plug/socket?.
57.2 aid plugs.
NBR Pull the feeding cable from the equipment with a 100N The cable does not
IEC 60601-2-13 power. During the test, the cable must not loose and the Mechanical loose nor fails during
57.3 a) equipment must going on operating normally. the test.
Place the anesthesia equipment with all its accessories, in
NBR IEC There is no equipment
the most unfavorable normal usage configuration: including
60601-1 instability or risk to the
its casters in the most unfavorable position, as well as ports
24.1 operator. It is
and drawers, on a 10-degree angle plan and check its Risk analysis
necessary to describe
stability. Repeat the test for all directions. If the equipment
IEC 60601-1 the transport position.
must be placed in a specific position to be stable, this must
9.4.2.1
be considered the transport position.
NBR IEC
If there is a transport position for the equipment, repeat the
60601-1 There is no equipment
latter test in the most unfavorable configuration on a 5-
24.1 Risk analysis instability of or risk to
degree angle plan and check its stability. Repeat the test for
IEC 60601-1 the operator.
all directions.
9.4.2.2
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NBR IEC
60601-1
28.1 There is no bearer
Gradually place 25kg on the cylinder bearer and keep it there
NBR IEC instability or damage,
during 1 minute. The bearer must not be instable or suffer Risk analysis
60601-1 nor risk to the
any damage.
28.1 operator.
IEC 60601-1
9.8.2
NBR IEC
There is no bearer
60601-1 Gradually place a 37.5kg mass on the generic bearer and
instability or damage,
28.4 keep it there during 1 minute. The bearer must not be Risk analysis
nor risk to the
IEC 60601-1 instable or suffer any damage.
operator.
9.8.2
NBR IEC
There is no bearer
60601-1 Gradually place a 50kg mass on the generic bearer and keep
instability or damage,
28.1 it there during 1 minute. The bearer must not be instable or Risk analysis
nor risk to the
IEC 60601-1 suffer any damage.
operator.
9.8.2
NBR IEC
During 1 minute, pour 75mL water uniformly on the table,
60601-1 The electrical parts
simulating a 30% overflow (twice the required by norm) from
44.2 Visual were not reached by
the vaporizer reservoir, in the natural position. Check if the
IEC 60601-1 water.
internal electrical parts of the equipment are reached.
11.6.2
NBR IEC
During 15 seconds, pour 200mL water on the upper part of
60601-1 The electrical parts
the equipment, in a constant way, from a height lower than
44.2 Visual were not reached by
5cm. Check if the internal electrical parts of the equipment
IEC 60601-1 water.
are reached.
11.3
NBR IEC
With a pipette, let some water drops fall on the connections, The equipment must
60601-1 Risk analysis
sealing and hoses that may be damaged. be safe.
44.4
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