Enraf-Nonius Mobile Stand SSV User manual

Enraf-Nonius
Brand
Enraf-Nonius
Model
Mobile Stand SSV
Type
User manual
Operating Manual
Index 2-EN
Page 1 of 14
Issue date: 2017-01-06
STAND SSV
Content
1
SAFETY SYMBOLS .................................................................................................................................... 2
2
GENERAL INFORMATION ...................................................................................................................... 2
3
APPROPRIATION ....................................................................................................................................... 2
4
POWER SUPPLY ......................................................................................................................................... 3
5
OPERATIONAL SAFETY .......................................................................................................................... 3
6
ENVIRONMENTAL CONDITIONS .......................................................................................................... 3
6.1
S
TORAGE
................................................................................................................................................. 3
6.2
O
PERATING
C
ONDITIONS
......................................................................................................................... 3
7
ACCESSORIES ............................................................................................................................................ 3
8
BEFORE THE USE ...................................................................................................................................... 4
9
START-UP ..................................................................................................................................................... 4
9.1
S
ETUP
...................................................................................................................................................... 4
9.2
C
HANGING OF
L
OCATION
......................................................................................................................... 4
9.3
S
TART
-U
P
................................................................................................................................................ 4
10
DAILY OPERATION ............................................................................................................................... 5
11
REGULAR TASKS ................................................................................................................................... 5
11.1
R
EGULAR
S
AFETY
C
HECKS
...................................................................................................................... 5
11.2
L
IMIT
V
ALUES FOR THE
A
NNUAL
S
AFETY
C
HECK
................................................................................... 5
11.3
C
ARE UND
M
AINTENANCE
....................................................................................................................... 5
11.4
S
URFACE
D
ISINFECTION
........................................................................................................................... 5
12
SERVICE ................................................................................................................................................... 6
13
LIMITED GUARANTEE ........................................................................................................................ 6
14
MANUFACTURER .................................................................................................................................. 6
15
TECHNICAL DATA ................................................................................................................................ 7
15.1
T
ECHNICAL
D
ATA
.................................................................................................................................... 7
15.2
S
TANDARDS AND
D
IRECTIVES
................................................................................................................. 7
15.3
E
LECTRICAL
S
AFETY
C
LASSIFICATION
.................................................................................................... 7
16
ASSEMBLY INSTRUCTION .................................................................................................................. 8
16.1
S
COPE OF
D
ELIVERY
................................................................................................................................ 8
16.2
T
OOL
-S
CREW
-S
ET
................................................................................................................................... 9
16.3
A
SSEMBLY
I
NSTRUCTION
......................................................................................................................... 9
16.3.1
Assembly of the Stand Base ....................................................................................................... 9
16.3.2
Assembly of the Telescopic Tube ............................................................................................ 10
16.3.3
Assembly of the Stand Arm ...................................................................................................... 11
16.3.4
Installation of the Infrared Spot TGS or IRS ........................................................................... 12
17
INSTALLATION CHECKLIST ........................................................................................................... 14
Operating Manual
Index 2-EN
Page 2 of 14
1 Safety Symbols
This symbol indicates a possible risk of danger. Read this manual
carefully and follow all safety advices that are marked by this sign.
This symbol indicates that the arm of the stand
SSV has to be fixed in the lowest position before
changing the location of the stand. Ignoring this
safety symbol bears risk for the patient, the
operator or other persons as well as risk for the
real values surrounding the equipment.
This symbol indicates the maximum permissible load at the
arm of the stand. Ignoring this safety symbol bears risk for
the patient, the operator or other persons as well as risk for
the real values surrounding the equipment.
This symbol warns against operating the foot pedal without
any load mounted to the arm of the stand. Ignoring this safety
symbol bears risk for the patient, the operator or other
persons as well as risk for the real values surrounding the
equipment.
2 General Information
The assembly of the stand SSV may be carried out by trained personnel only. It has
to be performed according to the assembly instructions (chapter 16.3 Assembly
Instruction) and documented by the enclosed installation checklist. This checklist
(signed by both user and mechanic) and the enclosed guarantee card have to be
sent to the manufacturer in original. It is the base for the limited warranty.
3 Appropriation
The stand SSV is intended to carry infrared spots of the series TGS and IRS
manufactured for Enraf-Nonius BV by Heuser Apparatebau GmbH. It is not intended
to carry other or additional loads. This use is contradictory to the appropriation and
not allowed.
Vor Standortwechsel
Infrarotstrahler in die
niedrigste Position bringen!
Maximale
Anhängelast
12,2 kg
Operating Manual
Index 2-EN
Page 3 of 14
4 Power Supply
The standard power supply for the stand SSV is 220-240V / 50/60Hz.
The fuse is 16 A maximum. A residual current protective device has to be installed.
Attention:
•
To avoid an electric shock the device may only be connected to a power
supply system that is equipped with a protective earth conductor.
•
For a complete disconnection from the power supply the plug has to be pulled
out of the socket. Unobstructed access to the socket has to be ensured, so
that in case of an emergency the plug may be pulled immediately.
•
The plug may never be pulled by the cable but only by the grip area. The plug
may never be touched with wet hands.
5 Operational Safety
The operating company is obliged to establish operational safety for the user of this
device. All legal requirements regarding operational safety have to be obeyed.
According to legal standards an annual safety check of the stand SSV has to be
performed and documented.
6 Environmental Conditions
6.1 Storage
The stand SSV has to be stored under the following conditions:
Storage temperature: -20 °C - +70 °C
Maximum relative humidity: 75 %, no condensation
Barometric pressure: 500-1060 hPa
6.2 Operating Conditions
Storage temperature: 0 °C - +40 °C
Maximum relative humidity: 75 %, no condensation
Barometric pressure: 500-1060 hPa
The stand SSV may only be used under dry conditions. All kinds of moisture have to
be kept away from the device. The use in explosive surroundings is not permitted.
7 Accessories
There is no accessory available for the stand SSV. Operation with non-approved
accessory will lead to the loss of warranty claim.
Operating Manual
Index 2-EN
Page 4 of 14
8 Before the Use
Before the use of the stand SSV the operator has to make sure that it is installed in a
tilt-proof way on a horizontal surface. The infrared spot has to be mounted according
to the installation instructions. All safety devices have to be present and correctly
installed. All stand roller brakes have to be locked. The maximum allowed load at the
arm of the stand may not be exceeded. It is not permitted to deposit or attach any
items on / to the stand. It is not permitted to lean any items against the stand. This
Operating Manual has to be kept close to the stand.
Missing safety devices discharge the manufacturer from every warranty liability.
9 Start-Up
9.1 Setup
The stand SSV is equipped with four lockable castors. The parking brakes may only
be released in case of a changing of location. The stand has to be positioned in a
way that all safety distances required by the installation instructions of the infrared
spot are achievable.
9.2 Changing of Location
Before changing the location of the stand SSV the power plug has to be pulled out.
The arm of the stand has to be lowered to the bottom position. After releasing the
parking brakes of the castors the stand may be pushed to the new location. Having
reached the desired position, the parking brakes have to be locked again.
It is not permitted to change the location of the stand by pushing / pulling at
the infrared spot!
Attention: Unevenness and obstacles on the floor increase the risk of
tipping!
9.3 Start-Up
Attention: Before using the stand SSV all legal safety instructions
according to the valid accident prevention regulations have to be
respected!
The power supply cable has to be laid in a way that there are no sharp bends or
clamped areas. Furthermore it has to be laid in a way that causes no risk of tripping
for patient, operator or other persons. During operation, the power supply cable may
not get moist or wet.
While pressing the foot pedal the level of the stand arm may be varied by
pushing / pulling the telescopic tube with moderate force. When reaching the desired
position, the pressure has to be released from the pedal. The arm is now fixed in the
position.
Changing the level of the stand arm by pushing / pulling at the infrared spot is
not permitted!
Operating Manual
Index 2-EN
Page 5 of 14
10 Daily Operation
Attention: Unsupervised operation with stand SSV and infrared spot,
even with a time switch, is not permitted!
For a well-organized daily use of the stand SSV we give the following non-binding
recommendations:
Infrared spots TGS and IRS are medical products with an own operating
instruction. For a patients treatment all requirements of those instructions are
obligatory!
At closing time the arm of the stand has to be lowered to the bottom position.
11 Regular Tasks
11.1 Regular Safety Checks
In the context of the infrared spots TGS or IRS an annual safety check of the stand
SSV has to be performed and documented.
11.2 Limit Values for the Annual Safety Check
Measurement Limit Value
Protective earth conductor resistance
< 0,2
Ω
Insulating resistance > 2,0 M
Ω
Enclosure leakage current < 100 µA
Earth leakage current < 0,5 mA
Measurements have to be taken while the infrared spot is installed. If any of the limit
values is exceeded, the operation of the stand SSV is prohibited!
11.3 Care und Maintenance
For care and maintenance of the stand SSV the national rules and guidelines
concerning the operation of devices in health care facilities have to be obeyed.
Stands SSV may only be cleaned with a moist, lint-free cloth. Liquid remnants
(cleaning agents, water) have to be removed immediately. Before cleaning, the
power plug has to be pulled out.
11.4 Surface Disinfection
Recommended surface disinfectants:
•
Biguamed Perfekt N, Hersteller Desomed –Dr. Trippen GmbH
•
Cleanisept Wipes, Hersteller Dr. Schumacher GmbH
•
Incidin Plus, Hersteller Ecolab Deutschland GmbH
•
Mikrozid AF liquid, Hersteller Schülke & Mayr GmbH
•
TPH protect, Schülke & Mayr GmbH
Operating Manual
Index 2-EN
Page 6 of 14
12 Service
Apart from regular cleaning the stand SSV is maintenance-free, if it is verifiably
mounted and operated according to this manual. In case of a defect the repairing has
to be executed by a qualified person. If the repairing can’t be done locally, the device
may be sent to Enraf-Nonius BV, The Netherlands for service and repairs.
13 Limited Guarantee
The function of the stand SSV is guaranteed by Enraf-Nonius BV, if it is verifiably
mounted and operated according to this manual.
The guarantee time is twelve months after the delivery to the dealer.
The guarantee is limited to repair or exchange to a new device; the decision is up to
Enraf-Nonius BV exclusively. Please keep the original packaging for the time of
guarantee. Guarantee will only be granted, if the device is sent back in original
packaging. Damages caused by insufficient wrapping will be charged to the
dispatcher.
Further compensations are not included in this limited guarantee.
14 Manufacturer
The stand SSV is manufactured for Enraf-Nonius BV by:
Heuser Apparatebau GmbH
Am Schlagbaum 10
42781 Haan
Germany
Operating Manual
Index 2-EN
Page 7 of 14
15 Technical Data
15.1 Technical Data
Dimensions
Length 810 mm
Front width 820 mm
Rear width 560 mm
Minimum height 1640 mm
Maximum height 2040 mm
Height of stand base (front) 65 mm
Nominal Voltage 220-240 V
Power frequency 50/60 Hz
Cross section of the power cable 3 x 1 mm²
Packing dimensions (L x W x H) 165 x 29,5 x 16 cm
Net weight 18,5 kg
Packing - gross weight 21,5 kg
All dimensions are given in SI-units
The stand SSV has the following features:
4 castors, lockable
Gas pressure spring for lifting support
Maximum lifting force 150 N
Abbreviation on the identification plate: SN: Serial number
15.2 Standards and Directives
The stand SSV complies with the safety requirements of the following standards,
laws and directives:
•
German Medical Devices Act
•
MDD 93/42/EWG, 2007 – Medical Device Directive
•
DIN EN 60601-1: 2007 – Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance
15.3 Electrical Safety Classification
The stand SSV is class 1 equipment. To avoid an electric shock the device may only
be connected to a power supply system that is equipped with a protective earth
conductor.
Degree of enclosure protection IP 20
Operating Manual
Index 2-EN
Page 8 of 14
16 Assembly Instruction
16.1 Scope of Delivery
1 Stand, base
2 Side profiles
3 Spacer
4 Middle profile
5 Foot pedal with screw
M4x35 and nut
6 Telescopic tube
7 Stand arm
Operating Manual
Index 2-EN
Page 9 of 14
16.2 Tool-Screw-Set
16.3 Assembly Instruction
The stand SSV may be assembled by trained personnel only. Before assembling the
stand all packaging material, aids and foils have to be removed. The delivery has to
be checked for completeness.
16.3.1 Assembly of the Stand Base
Fasten tightly the side profiles (2) with 2 countersunk screws M6x50 (d) each with the
stand, base (1), the spacer (3) and the middle profile (4) as shown in the picture.
Therefore the provided hexagon key 4 mm (a) may be applied.
a Hexagon key 4 mm
b Hexagon key 3 mm
c Open-end wrench 7 mm
d Countersunk screw M6x60 (4 pieces)
e Countersunk screw M5x16
f Grub screw M6x6 (2 pieces)
Operating Manual
Index 2-EN
Page 10 of 14
16.3.2 Assembly of the Telescopic Tube
Attention:
It is absolutely necessary to remove the white adhesive
tape and the white protection cap from the bottom part
of the telescopic tube (6).
Insert the bottom part of the telescopic tube (6)
into the mounting block of the stand, base (1) as
far as it will go. Make sure that the opening in the
telescopic tube and in the mounting block show in
the same direction.
Attention:
To allow a correct insertion of the telescopic
tube into the mounting block the spring
fixation may not stand out of the telescopic
tube!
Screw in the countersunk screw M5x16 (e) in the
mounting block to fix the telescopic tube in the
mounting block. Therefore the provided hexagon
key 3 mm (b) may be applied.
Spring fixation
wrong
correct
Adhesive tape
Protection cap
Operating Manual
Index 2-EN
Page 11 of 14
Loosen the nut M4 of the fixing
screw M4x35 of the foot pedal
(5) and remove the screw.
Therefore the provided
hexagon key 3 mm (b) and the
open-end wrench 7 mm (c)
may be applied. Insert the foot
pedal in the opening of the
mounting block; the fastening
sleeve must face downward.
Insert the fixing screw in the
brackets of the mounting block
and in the fastening sleeve of
the foot pedal and fix it with
the nut.
16.3.3 Assembly of the Stand Arm
Mount the arm of the stand (7) onto the top part of
the telescopic tube (6) as far as it will go. Align the
arm parallel to the side profiles (2). The drilling holes
in the arm and in the telescopic tube must lie on top
of each other.
Drilling holes
Drilling holes
Operating Manual
Index 2-EN
Page 12 of 14
Fasten the stand arm (7) on the telescopic tube (6) with the 2 grub screws M6x6 (f).
Therefore the provided hexagon key 3 mm (b) may be applied.
16.3.4 Installation of the Infrared Spot TGS or IRS
The infrared spot TGS or IRS may be installed by trained personnel only. For the
mounting of the infrared spot a second person is needed.
Loosen the fixing screw of the
safety sleeve and remove the
safety sleeve. Therefore the
provided hexagon key 3 mm (b)
may be applied.
Mind the
assembly position because the
safety sleeve is asymmetric!
Remove the securing segment from the
mounting device for the connection piece of the
infrared spot.
Mind the assembly position
because the securing segment is
asymmetric!
While one person keeps the safety
sleeve (mind the assembly position!) in
the highest possible position (step 1)
on the mounting device, the second
person inserts the connection piece of
the infrared spot as far as it will go into
the mounting device (step 2).
The first person inserts the securing
segment (mind the assembly position!)
into the corresponding slot (step 3).
2
3
1
2
3
Operating Manual
Index 2-EN
Page 13 of 14
Slide the safety sleeve down over the securing
segment as far as it will go.
Fasten the safety sleeve with the fixing screw.
Operating Manual
Index 2-EN
Page 14 of 14
17 Installation Checklist
Product Serial Number Date of Assembly
Stand SSV
Date, Signature
of the
Technician
Was the stand SSV installed on a horizontal
surface? yes
no
Are the safety distances that are required for
the infrared spots TGS and IRS observed? yes
no
Does the electrical connection comply with
the data on the identification plate? yes
no
Does the electrical installation have a residual
current protective device? yes
no
Does the residual current protective device
work properly? yes
no
Is the power supply fused with 16 A
maximum? yes
no
If any of the questions above is answered with „no“, the operation of the stand SSV is
not permitted. In case of defects or harm due to incorrect installation all guarantee
will be declined.
Date, signature of user: ______________________________________
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Enraf-Nonius Mobile Stand SSV User manual

Enraf-Nonius
Brand
Enraf-Nonius
Model
Mobile Stand SSV
Type
User manual
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