Operating Manual
Index 4-EN
Page 1 of 14
Issue date: 2017-01-06
STAND SSU
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 AND
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 4-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
SSU 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 SSU 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 SSU 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 4-EN
Page 3 of 14
4 Power Supply
The standard power supply for the stand SSU 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 SSU has to be
performed and documented.
6 Environmental Conditions
6.1 Storage
The stand SSU 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 SSU 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 SSU. Operation with non-approved
accessory will lead to the loss of warranty claim.
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8 Before the Use
Before the use of the stand SSU 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 SSU 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 SSU 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 SSU 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!
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10 Daily Operation
Attention: Unsupervised operation with stand SSU and infrared spot,
even with a time switch, is not permitted!
For a well-organized daily use of the stand SSU 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
SSU 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 SSU is prohibited!
11.3 Care and Maintenance
For care and maintenance of the stand SSU the national rules and guidelines
concerning the operation of devices in health care facilities have to be obeyed.
Stands SSU 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
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12 Service
Apart from regular cleaning the stand SSU 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 SSU 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 SSU is manufactured for Enraf-Nonius BV by:
Heuser Apparatebau GmbH
Am Schlagbaum 10
42781 Haan
Germany
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15 Technical Data
15.1 Technical Data
Dimensions
Length 800 mm
Front width 800 mm
Rear width 800 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 17,8 kg
Packing - gross weight 21,5 kg
All dimensions are given in SI-units
The stand SSU 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 SSU 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 SSU 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
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16 Assembly Instruction
16.1 Scope of Delivery
1 Stand, base
2 Side profiles
3 Spacer
4 Foot pedal with screw
M4x35 and nut
5 Telescopic tube
6 Stand arm
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16.2 Tool-Screw-Set
16.3 Assembly Instruction
The stand SSU 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 stand, base (1) and the side profiles (2) with a spacer (3) and
2 countersunk screws M6x50 (d) each. 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 M6x50 (4 pieces)
e Countersunk screw M5x16
f Grub screw M6x6 (2 pieces)
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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 (5).
Insert the bottom part of the
telescopic tube (5) 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!
Spring fixation
wrong
correct
Adhesive tape
Protection cap
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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.
Loosen the nut M4 of the fixing
screw M4x35 of the foot pedal (4)
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 (6) onto the top part of the
telescopic tube (5) 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
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Fasten the stand arm (6) on the
telescopic tube (5) 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!
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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).
Slide the safety sleeve down over the securing segment
as far as it will go.
Fasten the safety sleeve with the fixing screw.
1
2
3
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17 Installation Checklist
Product Serial Number Date of Assembly
Stand SSU
Date, Signature
of the
Technician
Was the stand SSU 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 SSU is
not permitted. In case of defects or harm due to incorrect installation all guarantee
will be declined.
Date, signature of user: ______________________________________
/
