Stiegelmeyer Seta pro User manual

Seta pro
2020-11-12 | Version 00 | 288675
Instruction Manual
Model variant junior

[1] Top handrail of the headboard (re-
movable at head end only)
[2] Laminate panel (removable at
head end only)
[3] Release button for top handrail on
the headboard (head end only)
[4] Full-length safety side (full-length,
both sides)
[5] Backrest [6] Handset (optional equipment)
[7] Universal holder, sliding, on both
sides
[8] Thigh rest
[9] Storage compartment for handset,
on both sides, lockable with mag-
netic key (if optional manual switch
has been selected)
[10] Lower leg rest
[11] Wall deflection rollers (4x) [12] Linen holder, extensible, with gal-
lery rail, lockable with magnetic
key
[13] Release button for safety sides (2x
per long side of the bed)
[14] Brake pedal (both sides) for oper-
ating castor brakes or for steering
[15] Grab handles/side mattress guides
(4x)
[16] Lever (on both sides) for manual
adjustment or CPR release of the
backrest
[17] Castors (4x)
Seta pro hospital bed (junior variant)

1
2
3
3.1
3.2
3.3
3.4
3.5
3.6
3.7
4
4.1
4.2
5
5.1
5.1.1
5.1.2
5.1.3
5.1.4
5.1.5
5.2
5.2.1
5.2.2
5.3
5.3.1
5.4
6
6.1
6.2
6.3
6.4
6.5
6.5.1
6.5.2
Contents
Address, market information................................................................................. 1
Foreword..................................................................................................................2
Target groups, qualifications and duties.............................................................. 3
Operator................................................................................................................................... 3
Responsibilities of the operator............................................................................................ 3
Users (medical personnel)..................................................................................................... 4
Users (technical personnel)................................................................................................... 4
Qualification of users..............................................................................................................4
Duties of users........................................................................................................................ 4
Patient...................................................................................................................................... 5
Conventions of this instruction manual............................................................... 6
Safety instructions.................................................................................................................. 6
Icon information...................................................................................................................... 7
Safety instructions..................................................................................................8
Safety information for operating the bed..............................................................................8
Electrical cables and connections...............................................................................8
Operating time of electric drives..................................................................................9
Handset/control boxes................................................................................................ 9
Handset (optional: handset/LCD handset)................................................................ 11
Bed adjustment......................................................................................................... 12
Special hazards..................................................................................................................... 13
Risk of fire................................................................................................................. 13
Electromagnetic interference.................................................................................... 14
Safety information for attachments, accessories and additional equipment..................15
Use of additional electromedical equipment............................................................. 15
Safety information for disposal........................................................................................... 17
Product description.............................................................................................. 19
Product Description.............................................................................................................. 19
Intended use.......................................................................................................................... 19
Use for the intended purpose.............................................................................................. 19
Side effects............................................................................................................................ 20
Components of the bed........................................................................................................ 20
Headboard and footboard......................................................................................... 20
Mattress base............................................................................................................20

6.5.3
6.5.4
6.5.5
6.5.6
6.5.7
6.5.8
6.5.9
6.5.10
6.5.11
6.5.12
6.5.13
6.6
6.6.1
6.6.2
6.6.3
6.6.4
6.6.5
6.6.6
6.6.7
6.6.8
6.6.9
6.6.10
7
7.1
7.2
7.3
8
8.1
8.1.1
8.1.2
8.2
8.3
8.4
8.5
8.6
8.7
Chassis..................................................................................................................... 20
Electric drive system................................................................................................. 21
Control units..............................................................................................................21
Safety sides...............................................................................................................34
Linen holder.............................................................................................................. 34
Mains cable holder....................................................................................................36
Adapter sleeves for patient lifting pole/infusion stand (optional)............................... 36
Universal holders (optional)...................................................................................... 37
Attachment points for posey belts (optional).............................................................38
Li-ion battery (optional)............................................................................................. 39
Lead-acid battery (optional)...................................................................................... 40
Technical data........................................................................................................................42
Type plate..................................................................................................................42
Other labelling on the product...................................................................................43
Materials used...........................................................................................................44
Dimensions............................................................................................................... 44
Weight....................................................................................................................... 45
Adjustment ranges.................................................................................................... 45
Operating noise.........................................................................................................45
Ambient conditions....................................................................................................45
Medical device classification.....................................................................................46
Electrical data............................................................................................................47
Putting into service...............................................................................................51
Safety information for putting into service.........................................................................51
Safety information concerning the place of use................................................................ 51
Safety information for electric hospital beds..................................................................... 52
Bed reprocessing/bed adaptation....................................................................... 53
New occupancy after a change of patient...........................................................................53
Information on loading capacity of bed..................................................................... 53
Requirements............................................................................................................54
Inserting the mattress...........................................................................................................54
Insert/remove patient lifting pole.........................................................................................55
Attaching the grab handle.................................................................................................... 57
Attaching an infusion stand................................................................................................. 58
Using universal holders........................................................................................................59
Laying the patient in the bed................................................................................................61

8.8
8.8.1
8.8.2
8.9
9
9.1
9.1.1
9.1.2
9.1.3
9.1.4
9.2
9.2.1
9.2.2
9.3
9.3.1
9.4
9.4.1
9.4.2
9.5
9.5.1
9.5.2
9.5.3
9.6
9.6.1
9.6.2
9.6.3
9.7
9.7.1
9.7.2
9.7.3
9.8
9.8.1
9.8.2
9.8.3
9.9
9.9.1
Restoring factory settings....................................................................................................61
On the LCD handset................................................................................................. 62
On the control box.....................................................................................................64
Decommissioning................................................................................................................. 64
Use/routine............................................................................................................ 65
Move and immobilise the bed.............................................................................................. 65
Safety information on moving, braking and immobilising the bed............................. 66
Moving the bed..........................................................................................................67
Immobilising the bed................................................................................................. 68
Move with steering lock.............................................................................................68
Locking/unlocking electric adjustment functions..............................................................69
On the LCD handset................................................................................................. 70
On the control box.....................................................................................................71
Setting the normal position..................................................................................................72
On the control box.....................................................................................................72
Setting the auto contour position........................................................................................72
On the handset..........................................................................................................73
On the LCD handset................................................................................................. 73
Setting the backrest.............................................................................................................. 73
On the handset..........................................................................................................73
On the LCD handset (optional)................................................................................. 74
On the control box.....................................................................................................75
Setting the bed height...........................................................................................................76
On the handset..........................................................................................................76
On the LCD handset................................................................................................. 76
On the control box.....................................................................................................77
Setting the thigh rest............................................................................................................ 77
On the handset..........................................................................................................77
On the LCD handset................................................................................................. 77
On the control box.....................................................................................................78
Setting a sitting or sleep position........................................................................................78
On the handset..........................................................................................................79
On the LCD handset................................................................................................. 79
On the control box.....................................................................................................80
Setting a Trendelenburg or Reverse-Trendelenburg Position.......................................... 80
Trendelenburg and reverse-Trendelenburg positions on the LCD handset.............. 80

9.9.2
9.9.3
9.10
9.10.1
9.10.2
9.11
9.11.1
9.12
9.12.1
9.13
9.13.1
9.13.2
10
10.1
10.1.1
10.1.2
10.2
10.2.1
10.2.2
10.3
11
11.1
11.2
11.2.1
11.2.2
11.2.3
11.2.4
11.3
11.3.1
11.3.2
11.3.3
11.3.4
11.4
11.4.1
11.5
Trendelenburg Position on the Control Box.............................................................. 81
Reverse-Trendelenburg Position on the Control Box................................................81
Switching under bed light on/off (optional equipment).....................................................82
On the LCD handset................................................................................................. 82
On the control box (optional).....................................................................................83
“Easy Care” function............................................................................................................ 83
Activation on LCD handset........................................................................................84
Using safety sides.................................................................................................................86
Full-Length Safety Sides...........................................................................................88
Remove/insert headboard handrail..................................................................................... 90
To remove................................................................................................................. 90
Insert......................................................................................................................... 91
Special functions.................................................................................................. 93
Setting the shock recovery position................................................................................... 93
On the LCD handset................................................................................................. 93
On the control box.....................................................................................................94
Setting CPR position.............................................................................................................95
On the LCD handset................................................................................................. 96
On the control box.....................................................................................................96
Emergency adjustments: Lowering the backrest fast....................................................... 96
Special bed adaptations.......................................................................................98
Attaching posey belts........................................................................................................... 98
Restricting the maximum mattress base height................................................................ 99
On the LCD handset................................................................................................. 99
Deleting the maximum mattress base height setting (on the LCD handset)........... 100
Setting the minimum mattress base height (on the control box)............................. 101
Deleting the maximum mattress base height setting (on the control box).............. 101
Restricting minimum mattress base height......................................................................102
Setting the minimum mattress base height (on the LCD handset)..........................102
Deleting the minimum mattress base height setting (on the LCD handset)............ 103
Setting the minimum mattress base height (on the control box)............................. 104
Deleting the minimum mattress base height setting (on the control box)............... 104
Setting an intermediate backrest stopping position (optional)...................................... 104
On the LCD handset............................................................................................... 105
Adjusting the sitting position and the normal position...................................................106

12
12.1
12.1.1
12.1.2
12.2
13
13.1
13.2
13.2.1
13.3
13.4
13.4.1
14
14.1
14.2
14.3
14.4
14.5
14.6
14.7
14.8
14.8.1
14.8.2
14.9
15
15.1
15.2
15.3
15.4
15.5
15.6
15.6.1
16
16.1
16.2
Cleaning and disinfection.................................................................................. 108
Safety information on cleaning and disinfection............................................................. 108
Before starting cleaning.......................................................................................... 108
After cleaning.......................................................................................................... 108
Manual cleaning.................................................................................................................. 109
Maintenance.........................................................................................................111
Service address................................................................................................................... 111
Safety instructions on maintenance.................................................................................. 111
Legal principles....................................................................................................... 112
Recommended special varnishes......................................................................................112
Servicing plan...................................................................................................................... 113
Periodic inspection.................................................................................................. 114
Replacement of electrical components.............................................................116
Safety instructions.............................................................................................................. 116
Replacing the battery (lead-acid/Li-ion)............................................................................ 117
Mains cable replacement.................................................................................................... 119
Connect the earth conductor............................................................................................. 120
Replace handset..................................................................................................................121
Replace the control box......................................................................................................121
Replace the control unit..................................................................................................... 122
Initialising the control......................................................................................................... 123
On the LCD handset............................................................................................... 124
On the control box...................................................................................................126
Programming the LCD handset......................................................................................... 126
Troubleshooting.................................................................................................. 129
Faults and their rectification.............................................................................................. 129
Fault display on LCD handset............................................................................................132
RESET: Acknowledging faults on LCD handset...............................................................134
Displaying/deleting last fault on LCD handset................................................................. 135
Fault messages on control box......................................................................................... 137
RESET: Acknowledge faults on control box.....................................................................140
On the control box...................................................................................................140
Disposal............................................................................................................... 141
Disposal of the bed............................................................................................................. 141
Disposal of packaging........................................................................................................ 141

16.3
16.3.1
16.3.2
17
17.1
17.2
17.2.1
17.3
17.4
17.5
Disposal of components.....................................................................................................141
Electrical components.............................................................................................141
Batteries..................................................................................................................142
Appendix..............................................................................................................144
Available accessories......................................................................................................... 144
Information on electromagnetic compatibility (EMC)...................................................... 145
EMC information tables...........................................................................................146
Inspection report................................................................................................................. 149
Inspection by the user........................................................................................................ 154
Translation of EC Declaration of Conformity....................................................................156

1 Address, market information
Manufacturer
Stiegelmeyer GmbH & Co. KG
Ackerstraße 42, D-32051 Herford, Germany
Phone: [phone] - 0
Fax: [phone] - 252
Email:[e-mail]
Internet:www.stiegelmeyer.com
To order replacement parts in Germany and for any servicing requirements or other ques-
tions, please contact our service centre:
Stiegelmeyer GmbH & Co. KG
Ackerstraße 42, D-32051 Herford, Germany
Phone:[phone] - 777
Fax:[phone] - 219
Email:[e-mail]
Internet:www.stiegelmeyer.com
Customers outside Germany can contact our distribution companies in their particular coun-
try if they have any questions. Contact details can be found on our website.
No part of this manual may be reproduced without the prior written permission of the publish-
er.
All rights reserved.
Subject to technical changes without notice!
This product is not licenced for use on the North American market. This applies particularly to
the United States of America. The distribution and use of this hospital bed in these markets,
including through third parties, is prohibited by the manufacturer.
1 Instruction Manual

2 Foreword
Dear Customer,
Stiegelmeyer has built this bed to give you the best possible help with the challenges posed
by nursing and caregiving. We passionately pursue the goal of developing products that are
durable and of a high-quality. Our products should make patients feel as safe and comforta-
ble as possible during their stay in bed and also lighten the workload of nursing and care
staff. For this reason, the electrical safety and all functions are tested prior to delivery. Each
bed leaves our factory in perfect condition.
Correct operation and care are necessary to keep the bed in excellent condition during long-
term use. Please therefore read and observe these instructions carefully. They will help you
to put the bed into service for the first time and to use it on a daily basis. This instruction
manual contains all the information you will need to make it as easy and safe as possible to
control and handle this bed, both for you as the operator and for your users. It is a practical
reference book and should be kept close to hand at all times.
Even after you have purchased a bed, Stiegelmeyer is still on hand to help at any time. Our
Assist business division can provide you with customised solutions in all matters relating to
inspection and maintenance, repair and process optimisation. You can contact our service
centre in Germany by phone on [phone] - 777. Customers outside Germany can
contact our distribution companies in their particular country if they have any questions. Con-
tact details can be found on our website www.stiegelmeyer.com.
We wish you and your users every success and satisfaction in caring for your patients.
Stiegelmeyer GmbH & Co. KG
Instruction Manual 2

3 Target groups, qualifications and
duties
3.1 Operator
3.2 Responsibilities of the operator
An operator (e.g. clinic, hospital, hospital administration) is every natural and legal person
with property rights to the product. The operator is responsible for the safe operation of this
medical product.
Operators of medical beds in Europe are obliged, in accordance with the new Medical Device
Regulation (EU) 2017/745 (MDR) and any existing additional relevant national laws/regula-
tions, e.g. in Germany the Medical Devices Operator Ordinance (Medizinprodukte-Betreiber-
verordnung, German abbreviation: MPBetreibV), to ensure the long-term safe operation of
this medical product with no risk of danger to patients, users or third parties. In other coun-
tries outside Europe the relevant national regulations concerning the duties of the operator
must be followed!
Only permit persons who have been properly instructed to use this bed!
•Using this instruction manual, which is provided with this hospital bed, ensure that ev-
ery user is instructed in the safe operation of this bed before using it for the first time!
•Draw every user’s attention to the possible hazards that can arise if the hospital bed is
improperly used. This applies in particular to the use of electrical drives and safety
sides!
•Make sure that substitute staff are also sufficiently well instructed in the safe operation
of the hospital bed!
•Ensure that users know where this instruction manual is kept!
Check to ensure that the safety instructions are adhered to!
If the hospital bed is in long-term use, test the functions and check for any visible damage
after a reasonable period of time (at least once a year)!
If the owner of the hospital bed changes, the instruction manual should be handed over with
the bed.
If any other equipment is attached to the bed, (e.g. compressors for positioning systems,
etc.), ensure that this is securely fastened and is functioning properly.
If you have any queries or concerns, consult the manufacturer of the equipment or Stiegel-
meyer.
3 Instruction Manual

3.3 Users (medical personnel)
3.4 Users (technical personnel)
3.5 Qualification of users
3.6 Duties of users
Users (e.g. medical specialists, doctors, nursing staff, carers and attendants, ...) are persons
who, based on their training, experience or briefing, are qualified to operate the bed on their
own authority or to carry out work on it, or have been instructed in how to handle this bed.
Furthermore, they can recognise and avoid potential dangers and assess the clinical condi-
tion of the patient.
Users with a technical background, such as company technicians, service engineers or per-
sons who are capable of carrying out special technical work on the hospital bed due to their
training or briefing through the operator.
The operator must only appoint users with the following three minimum qualifications to oper-
ate the hospital bed:
•Medical training
•Experience in dealing with patients and hospital beds
•Instruction in handling this hospital bed through the operator
For adjusting (technician control level of the LCD handset) and maintaining the hospital bed,
the operator must only appoint persons with the following minimum qualification:
•Technical experience of setting and maintaining hospital beds
•Have read and understood the special operation and maintenance instructions for this
bed (technician control level of the LCD handset) contained in this instruction manual
Ensure that the operator instructs you in the safe operation of this bed.
In Europe: Before using a hospital bed, you, as the user, must check each time that the hos-
pital bed is fully functional and in perfect working order, and must observe the instructions in
the instruction manual - particularly the safety information - during operation and mainte-
nance in accordance with the new Medical Device Regulation (EU) 2017/745 (MDR). Only by
doing so can operating errors be prevented and correct handling ensured in order to prevent
injuries and damage from occurring.
In other countries: The relevant national regulations concerning the duties of the operator
must be followed!
Target groups, qualifications and duties
Instruction Manual 4

CAUTION
3.7 Patient
Please also follow the corresponding instructions in the instruction manual for accessories at-
tached to the bed.
Pay special attention here to the safe routing of all loose connector cables, tubing, etc.
Ensure that no obstacles such as bedside cabinets, supply rails or chairs could impede ad-
justments to the bed.
If other equipment (e.g. compressors for positioning systems, etc.) is attached, ensure that
all items of equipment are securely fixed and function properly.
If you have any queries or concerns, consult the manufacturer of the equipment or Stiegel-
meyer.
Risk of injury
Failure to heed this warning may result in physical injury and material damage!
•If any damage or malfunction is suspected, take the bed out of service.
•Unplug the bed from the mains supply immediately.
•Indicate clearly that the hospital bed is “OUT OF ORDER”.
•Report this immediately to the operator responsible.
A patient is defined as a person who is in need of care, ill, infirm or disabled, and occupies
this bed.
It is a requirement that the operator or user instructs each new patient in the bed functions
that are important for him/her.
Target groups, qualifications and duties
5 Instruction Manual

4 Conventions of this instruction
manual
4.1 Safety instructions
WARNING
CAUTION
ATTENTION
In this instruction manual, safety information is displayed in the following way:
WARNING
•WARNING indicates a potentially hazardous situation that, if not avoided, could result in
death or serious injury.
CAUTION
•CAUTION indicates a potentially hazardous situation that, if not avoided, could result in
minor or moderate injury.
ATTENTION
•NOTICE indicates a harmful situation that could result in damage to the product or some-
thing around it.
The safety symbols used are not a substitute for the written safety information. It is important
therefore to read the safety information and follow the instructions exactly!
Instruction Manual 6

4.2 Icon information
General information, tips and helpful courses of action.
General information and cross-references will be displayed in the following way:
Cross-reference or active link: Indicates the chapter name and page
number of the instruction manual where you will find what you are look-
ing for. Example: Safety instructions »8
Conventions of this instruction manual
7 Instruction Manual

5 Safety instructions
5.1 Safety information for operating the bed
WARNING
5.1.1 Electrical cables and connections
WARNING
Danger when used for unsuitable patient groups
This hospital bed is only suitable for patients (children and small adults) with a height of 125
cm to 155 cm.
•When used for smaller patients there is a potential increased risk of entrapment/strangu-
lation and falls within and over raised safety sides and between raised mattress base
parts.
⁃This hospital bed may only be operated by persons who have received instruction from
the operator in its safe operation.
⁃Electrical adjustments are only possible when the hospital bed is properly connected to
the mains supply (exception: emergency battery operation).
⁃If the owner of the hospital bed changes, the instruction manual must be handed over
with the bed.
Risk of electric shock
Failure to heed this warning may result in fatal electric shocks due to damaged mains power
cables! Take the following measures to prevent hazards due to electric shock and malfunc-
tions.
•Replace damaged mains power cables immediately! If a damaged mains cable continues
to be used, this can lead to electric shock, fire and other hazards as well as malfunctions.
•Connect the bed only to a properly earthed mains electrical socket.
Instruction Manual 8

5.1.2 Operating time of electric drives
5.1.3 Handset/control boxes
Continuous operation must not exceed two minutes. After this time, a rest period of at
least 18 minutes must be observed.
If the electric drive is operated for a much longer period, e.g. due to the patient continual-
ly "playing" with the handset, the electronic thermal protection device integrated in the
control unit will deactivate the thermal protection device temporarily.
In this extremely rare case, the control unit will be available for use again after cooling
down for approximately 20 minutes.
•Route the mains cable in such a way that it cannot be pulled, driven over or damaged by
moving parts, or in any other way, when the bed is operated. Before moving the bed, al-
ways make sure that you have unplugged it from the mains supply.
•Before moving the bed, always make sure that you have unplugged it from the mains
socket.
•Hang the mains cable in the mains cable holder provided on the headboard to ensure that
it will not fall off or trail on the floor.
•At weekly intervals when the bed is being used, carry out a visual inspection of the mains
cable to check for damage (scuffing, exposed wires, kinks, pressure points, etc.). A check
should also be performed whenever the cable has been subjected to any mechanical
load, e.g. has been driven over by the bed itself or by an equipment trolley, or whenever
the cable has been bent, stretched or violently pulled, e.g. due to the bed rolling away
while it is still plugged into the mains socket, and before plugging the cable back into the
mains socket whenever the bed has been moved or relocated.
•Check the strain relief of the power mains cable regularly to ensure that it is securely
fixed.
•Do not place multiple socket bars under the bed. This could cause electrical hazards due
to damaged mains cables or penetrating fluids.
•Do not continue to use the bed if you suspect that the mains cable could be damaged.
Adjustments must only be performed by a person trained by the operator, or in the presence
of a trained person!
Safety instructions
9 Instruction Manual

WARNING
WARNING
Risk of injury and strangulation for children
Handsets and their cables must be stored safely out of reach of children when not in use if
children are left unsupervised in the same room as the bed.
•Stow all existing hand sets with cables in storage compartments located in the centre un-
der one or both long sides of the mattress base.
•Lock these storage compartments with the magnetic lock provided with them. More de-
tails: Handset (Standard) »22.
Risk of injury and strangulation for children
Control boxes and their cables must be kept out of reach of children when not in use if chil-
dren are left unsupervised in the same room as the bed.
•Stow any control boxes, if available, in the place provided in the linen holder at the foot
end of the bed.
•Lock the linen holder with the magnetic lock provided with it to prevent it from being pulled
out. More details: Control box »30.
In this way you avoid possible entrapment and crushing hazards for unsupervised chil-
dren, lying in bed or playing around the bed, due to unauthorised activation of electrical
bed adjustments and potential strangulation hazards due to loose cables. The following
sticker on the storage compartments and the linen holder reminds you to safely store the
handsets/control boxes (if available):
Safety instructions
Instruction Manual 10

5.1.4 Handset (optional: handset/LCD handset)
ATTENTION
ATTENTION
ATTENTION
Material damage
Failure to heed this warning may result in collisions between the handset and other items or
equipment. This can lead to defects or accidentally trigger unlocked adjustment functions.
•When not in use, stow the handset in the holders on the bed in such a way that it cannot
inadvertently fall off, and ensure that the keypad on the outside of the bed is protected
from unintended use.
Material damage
Failure to heed this warning may result in system faults due to locked adjustment systems.
•When routing the handset cable, ensure that it cannot be crushed, stretched or otherwise
damaged by any moving parts of the bed.
•Hang the handset with the keypad facing the inside of the bed.
Material damage
Failure to heed this warning may result in damage to property which could adversely impact
the loading capacity of the hospital bed or its adjusting functions. Before carrying out any
electrical adjustments, make sure that
•No obstacles such as bedside cabinets, supply rails, other equipment, chairs or wall pro-
tection rails are in the way,
•There are no objects lying on the chassis,
•People are not sitting on slightly raised sections of the backrest and leg rests.
Safety instructions
11 Instruction Manual