DX 5010 Verification Plan

VERIFICATION PLAN OF HOSING TO DX 5010 VL50133A
PAGE: 1 of 9
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
<>
DIXTAL
Property of DIXTAL. Confidential information. Reproduction or distribution is prohibited.
PAGE: 2 of 12
REFERENCES
<List all mentioned documents>
MATERIAL
<Describe materials, equipment and tools necessary for the verification performance>
OBSERVATIONS
<If necessary, write here other information, notes>
DIXTAL
PAGE: 3 of 12
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.
DIXTAL
PAGE: 4 of 12
All o’rings of the

Specification Check if all o’rings of the patient circuit are in medical grade Verification of product
patient circuit are in
MC 45 silicone. structure.
medical grade silicone
Check if the APL exhaustion follows the 30mm conic FEQ related OK,
Specification Review of inspection
standard and may be connected through standard pipes to piping fits properly to
MC 53 and visual documents
the independent anti-pollution system. exhaustion.
Specification There is a filter
MC 58 Check if manometer and pressure sensor are protected by a protecting the
Visual
ISO 8835-2 hydrophobic filter at the taking pressure line. manometer and the
8.1.3 sensor.
Specification Check if the outlet of the fresh gas flow is easily accessible The FGF outlet is
Visual
MC 71 to the user, in the frontal part of the equipment. accessible to the user.
The outlet to the aid
Specification Check if the outlet of for the aid flowmeter is placed in the flowmeter is places in
Visual
MC 72 frontal part of the equipment the frontal part of the
equipment.
The outlet to the
Specification Check if the outlet for the aspirator is placed in the left side aspirator is placed in
Visual
MC 73 of the equipment. the left side of the
equipment.
Specification The airway
MC 74 Check if the airway manometer is placed in the frontal part of manometer is placed
Visual
ISO 8835-2 the equipment, visible, but independent of the circle filter. in the frontal part of
8.1.1 the equipment.
Check if manometers of gas inlet are placed in the frontal The gas inlet
Specification part of the equipment, from left to right following this order: manometer is placed
Visual
MC 75 oxygen, nitrous oxide, air, and oxygen from the spare in the frontal part of
cylinder. the equipment.
Specification Place 5kg in each draw and check if they do not suffer any The drawers bear 5kg
Visual
MC 76 damage or deformity. each.
DIXTAL
PAGE: 5 of 12
Specification There is a key for the

Check if there is a key for the upper drawer. Visual
MC 77 upper drawer.
Specification Place 20kg on the upper table and check if it does not suffer The upper table bears
Visual
MC 78 any damage or deformity. 20kg.
Specification Place 5kg on the lower table and check if it does not suffer The lower table
Visual
MC 78 any damage or deformity. supports 5kg.
There is an integrated
The DX 2020 monitor bearer is integrated to the equipment,
Specification articulate bearer for
has internal plug, is articulated, and bears the weight with no Visual
MC 79 the DX 2020 is and it
damage or deformity.
bears its weight.
The monitor generic bearer is articulated, with external plug. There is a generic
Specification
Check if it bears the DX 2010 weight with no damage or Visual articulate bearer for
MC 80
deformity. the DX 2010.
The generic articulate
bearer supports the
Check if the generic bearer supports safely the other DIXTAL
Specification DX 2023 e DX 2022
monitors: DX2023 and DX2022. Check the presence of a Visual
MC 80 monitors and the
dedicated and functional plug for these monitors.
dedicated plug is
functional.
The upper part of the
Specification Place 20kg on the upper part of the equipment and check if it
Visual equipment bears
MC 81 does not suffer damage or deformity.
20kg.
Both frontal casters
Specification Check if the equipment has 4 carters and if the frontal ones
Visual have lock, the back
MC 82 have lock.
ones do not.
DIXTAL
PAGE: 6 of 12
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
DIXTAL
PAGE: 7 of 12
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
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
7.2.18 the connectors (6bar).
NBRIEC60601-1
6.1 y) Check if the ground functional terminal is identified by its
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)
DIXTAL
PAGE: 8 of 12
The wires mentioned

NBR IEC
Check if only the internal ground wires for protection are are identified by green
60601-1 Visual
identified by green and yellow insulating material. and yellow insulating
6.5 b) c)
material.
All red and yellow
NBR IEC Check if the red LEDs indicate a warning related to high
LEDs are in
60601-1 priority alarms and the yellow ones indicate caution or Visual
accordance with the
6.7 a) attention (alarm and battery use).
description.
IEC 60601-1 Check if the Danger and Attached Documentation symbols
7.3.3 are next to the batteries.
NBR IEC
60601-1 There are no sharp-
Check if the anesthesia equipment presents sharp edges or
23 Visual edges or cutting
cutting surfaces.
IEC 60601-1 surfaces.
9.3
NBR
IEC 60601-2-13 Check the manufacturer’s address mark (Manaus). Visual The mark is present.
6.1. aa)
Check the serial number mark, with the respective symbol..
NBR
IEC 60601-2-13 Visual The mark is present.
6.1. aa)
NBR
Check the flow direction mark to the inspiratory and
expiratory ports of the patient connection.
6.1. aa)
DIXTAL
PAGE: 9 of 12
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
the power of the aid power net plugs. (2400VA)
6.1 j)
NBR
Check the presence of a label with information on the
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)
DIXTAL
PAGE: 10 of 12
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
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
DIXTAL
PAGE: 11 of 12
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
DIXTAL
PAGE: 12 of 12
Use the equipment in ventilation default conditions and

Specification Technical failure There are no failures
2L/min FGF during 8 hours, in a room with temperature
MC 3 occurrence due to temperature.
controlled at 15 degrees.
Use the equipment, in ventilation default conditions and
Specification Technical failure There are no failures
2L/min FGF during 8 hours in a room with temperature
MC 3 occurrence due to temperature.
controlled at 35 degrees.
THIS MUST BE THE LAST TEST The marks must
Establishment of mark durability: handily rub, with no remain clearly visible
NBR IEC
improper pressure, with a cloth soaked in distilled water firstly and the adhesive
60601-1 Visual
during 15s. Then, for more 15s, rub with a cloth soaked with tapes must not be
6.1
methanol. Finally, during more 15s, rub with a cloth soaked loosening or present
with propane. rolled corners.
Check if all materials in contact with the patient gas are non-
NBR toxic or allergenic. The materials allowed: anodized
Project memorial All materials are non-
IEC 60601-2-13 aluminum, stainless steel, polycarbonate, polyurethane,
analysis toxic.
56.1 polypropylene, nylon, brass with chrome protection. Materials
not allowed: latex, brass, nickel, steel.
DIXTAL

DX 5010 Verification Plan

Diunggah oleh

Informasi Dokumen

Judul Asli

Hak Cipta

Format Tersedia

Bagikan dokumen Ini

Bagikan atau Tanam Dokumen

Opsi Berbagi

Apakah menurut Anda dokumen ini bermanfaat?

Apakah konten ini tidak pantas?

Hak Cipta:

Format Tersedia

DX 5010 Verification Plan

Diunggah oleh

Hak Cipta:

Format Tersedia

VERIFICATION PLAN OF HOSING TO DX 5010 VL50133A

<List all mentioned documents>

<If necessary, write here other information, notes>

All o’rings of the

Specification There is a key for the

The wires mentioned

Use the equipment in ventilation default conditions and

Anda mungkin juga menyukai