Otto Bock B400 User manual

Instructions for Use (Qualified Personnel)
B400

Ottobock | 3B400
Foreword1 5................................................................
Application2 5............................................................
Intended Use2.1 5....................................................
Indications2.2 6.......................................................
Contraindications2.3 6..............................................
Necessary qualifications2.4 6.....................................
Safety3 6.....................................................................
Explanation of Warning Symbols3.1 6.........................
General safety instructions3.2 6.................................
Safety instructions for assembly3.3 7..........................
Programming safety instructions3.4 8.........................
Further Information3.5 9............................................
Name plate3.6 10.....................................................
Delivery4 11................................................................
Scope of supply4.1 11..............................................
Options4.2 11..........................................................
Storage4.3 11..........................................................
Preparation for Use5 12............................................
Tools required5.1 12.................................................
Initial operation5.2 12...............................................
Installing the fuse5.2.1 13............................................
Charging the battery5.2.2 13........................................
Adjustments6 13........................................................
Prerequisites6.1 13..................................................
Basic Settings6.2 14.................................................
Changing control unit parameters6.3 14......................
Wheelchair control options6.3.1 14...............................
Attendant control6.3.2 14.............................................
Handover7 14.............................................................
Final inspection7.1 14...............................................
Transport to the customer7.2 15.................................
Reducing the transportation size7.2.1 15.......................
Preparing for transport7.2.2 16.....................................
Handover7.3 16.......................................................
Maintenance / repair8 16..........................................
Disposal9 17...............................................................
Disposal Information9.1 17........................................
Information on Re-Use9.2 17.....................................
Legal Information10 17...............................................
Liability10.1 17..........................................................
CE Conformity10.2 18................................................
Warranty Terms and Conditions10.3 18........................
Trademarks10.4 18....................................................
Table of contents
Table of contents

Appendices11 19..........................................................
Technical data11.1 19.................................................
4 | Ottobock B400
Table of contents

1 Foreword
INFORMATION
Date of the last update: 2013-08-15
►Please read this document carefully.
►Follow the safety instructions.
INFORMATION
Missing instructions for use or service manuals can be
downloaded from the homepage at www.ottobock.com.
Missing instructions for use can also be ordered directly
from the manufacturer's service department (see back cov
er or inside back cover for addresses).
Initial adjustments to the wheelchair were made according
to the order form. Nevertheless, fine adjustment may be
required and settings may have to be made according to the
medical conditions or the user's requirements.
These instructions for use provide the information necessary
for adjusting the settings. This work should be closely
coordinated with the user.
Please note the following:
• The instructions for use (qualified personnel) are inten
ded only for qualified personnel and remain with them.
• The operation of the product and functionality of the
options are described in the instructions for use (user).
These instructions for use must be given to the user.
• All users and/or their attendants must be trained by you
in use of the product with the aid of the instructions for
use (user). In particular, the user(s) and/or attendant(s)
must be informed of the residual risk using the safety
instructions in the instructions for use (user).
• The manufacturer recommends checking the product
settings regularly in order to assure an optimum fit over
the long term. A review is required every six months for
children and youths in particular.
• The installation and retrofitting of all optional compon
ents are generally described in the service manual.
2 Application
2.1 Intended Use
The wheelchair is intended solely for personal use by people
who are unable to walk or have a walking impediment, as a
means of transport operated by themselves or another per
son for everyday indoor and outdoor use. An option is avail
able to allow an attendant to control the power wheelchair
using an attendant control.
The wheelchair may only be used with the options which are
listed in the product order form.
The manufacturer assumes no liability for combinations with
medical devices and/or accessories from other manufactur
ers outside of the modular system.
The operational safety of the wheelchair can only be ensured
if it is used properly in accordance with the information con
Ottobock | 5B400
Foreword

6 | Ottobock B400
tained in these instructions for use (qualified personnel) and
in the instructions for use (user). The user is ultimately
responsible for accident-free operation.
2.2 Indications
The broad range of equipment options and the modular
design allow the wheelchair to be used in case of an inability
to walk or walking impediment, for example due to:
• Paralysis (paraplegia/tetraplegia)
• Loss of limbs (leg amputation)
• Limb defect/deformity
• Joint contractures / defects
• Neurological and muscular diseases
The following aspects should also be considered for custom
fittings:
• Body size and body weight (max. load capacity 140 kg /
310 lbs for standard version)
• Physical and mental condition
• Age of the patient
• Living conditions/environment
2.3 Contraindications
Due to the given seat dimensions, this wheelchair type can
not be used to fit children.
2.4 Necessary qualifications
The installation and adjustments described below may only
be carried out by qualified personnel.
3 Safety
3.1 Explanation of Warning Symbols
WARNING Warnings regarding possible risks of severe
accident or injury.
CAUTION Warnings regarding possible risks of acci
dent or injury.
NOTICE Warnings regarding possible technical dam
age.
3.2 General safety instructions
WARNING
Non-observance of safety instructions
Risk of pinching, crushing, tipping, falling, product mal
function/defect
►Observe all safety instructions in these instructions for
use and in all other applicable documents.
Safety

Ottobock | 7B400
WARNING
Incorrect settings
Risk of falling, tipping over or improper user posture due to
incorrect settings
►Adjustments may only be carried out by qualified per
sonnel instructed by the manufacturer.
►Check for safe function before delivering the product.
WARNING
Improper handling of packaging materials
Risk of suffocation
►Keep packaging materials away from children.
CAUTION
Wearing of unsuitable work clothing
Chemical burns due to insufficient protection
►Wear suitable work clothing (for example, gloves and
protective eyewear) when working on the batteries.
CAUTION
Use of unsuitable tools
Pinching, crushing or damaging the product
►When working, use only tools that are suitable for the
conditions at the workplace and whose proper use
ensures safety and health protection.
NOTICE
Improper preparation before making adjustments
Risk of damage to the product
►When you work on the product, secure it so that it can
not tip over or fall down.
►Turn the power wheelchair off and remove the fuse
before making any adjustments. Functional tests of the
electrical components are excepted from this rule.
►Before performing any work on the seat, ensure that
the cushion is sufficiently protected against mechanic
al, chemical, and thermal effects.
NOTICE
Use of unsuitable packaging
Damage caused by transport in the wrong packaging
►Use only the original packaging for delivery of the
product.
3.3 Safety instructions for assembly
WARNING
Exposed pinch points
Risk of pinching, crushing of limbs
Safety

8 | Ottobock B400
►While adjusting power seat options, note that inherent
pinch and shear points are located between the seat
frame and the power wheelchair frame.
►Ensure that no body parts, such as hands or feet, are
in the danger zone while you make adjustments to
power seat options.
CAUTION
Unsecured screw connections
Risk of pinching, crushing, tipping over, falling of user
►After all adjusting/readjusting work, retighten the
mounting screws/nuts firmly. Observe any torque set
tings which may be specified.
►Any time you loosen a screw connection with thread
lock, replace it with a new screw connection or secure
the old screw connection with medium strength thread
locker (e.g. Loctite 241®).
CAUTION
Improper lifting
Risk of pinching/crushing, blows to limbs
►Some parts of the power wheelchair, such as the bat
teries, frame, seat, and motors, are very heavy. Ensure
ergonomically correct lifting of these parts. Use suffi
ciently large hoisting devices or perform this work with
a helper.
►If it is necessary to work underneath raised parts or
equipment, make sure these are secured by suitable
means so that they cannot come loose, shift, or fall
down.
►When using lifting platforms, ensure that the power
wheelchair is centred on the platform and that no parts
protrude into the danger zone.
CAUTION
Improper assembly after making adjustments
Tipping over, falling due to incorrect assembly and settings
►Verify that the anti-tipper has been installed and adjus
ted properly.
CAUTION
Uncontrolled movement of components when making
adjustments
Risk of crushing, pinching, blows to limbs
►Ensure that body parts, such as hands or head, are
never in the danger zone.
►Perform the work with the aid of a helper for support.
3.4 Programming safety instructions
WARNING
Incorrect configuration settings
Falling, tipping over, collision due to programming errors
Safety

Ottobock | 9B400
►Programming may only be performed by qualified per
sonnel trained by the manufacturer. The manufacturer
of the product and the control unit manufacturer are
not liable in case of damage caused by programming
which was not performed properly and/or which was
not adjusted properly according to the user's abilities.
►Note that modified parameter settings in the configura
tion can lead to changes in driving characteristics. In
particular, changes to the speed, acceleration, braking
or joystick settings can lead to unexpected and there
fore uncontrollable driving characteristics and cause
an accident.
►After configuration/programming is complete, the user
must test the driving characteristics of the product
under the supervision of the qualified personnel.
3.5 Further Information
INFORMATION
The serial number required for further inquiries and orders
is found on the nameplate (see section "Nameplate").
Safety

3.6 Name plate
Label Meaning
AType designation
BRead the instructions for use before using the product. Observe safety
information in the instructions for use.
CSymbol for separate collection of electric and electronic devices. Com
ponents of the power wheelchair and batteries may not be disposed of in
household waste.
DEuropean article number (EAN)
EProduct reference number
FSerial number (including year of manufacture)
GMaximum load capacity (see section "Technical Data")
HMaximum climbing ability (see section "Technical Data")
IMaximum speed (see section "Technical Data")
JAllowable axle load, front
KAllowable axle load, rear
LMaximum gross weight
MManufacturer information/address
The name plate is located on the side of the frame
below the seat. NCE marking – product safety according to EU guidelines
See the instructions for use (user) for additional warning labels
10 | Ottobock B400
Safety

4 Delivery
4.1 Scope of supply
The scope of delivery includes:
• Fitted power wheelchair with main components
• Options installed according to the order
• Battery charger
• Instructions for use (qualified personnel), instructions
for use (user)
4.2 Options
The functionality and operation of the options are described
in more detail in the instructions for use (user).
All of the available options/accessories are listed on the
order form.
4.3 Storage
NOTICE
Deep discharge due to standby current
Risk of battery damage
►Remove the fuse if the wheelchair is not used for more
than 3 days.
INFORMATION
To remove the fuse: see Page13.
Storage Conditions
• Maintain an ambient temperature between -40 °C and
+65 °C and relative humidity between 45 % and 85 %.
• Store the product in a dry, enclosed room with sufficient
air circulation and protection from external influences.
• Protect the wheels against ground frost, e.g., by reliev
ing them completely through assembly blocks or
wooden boards.
• Fill the wheels with slight overpressure and rotate them
at regular weekly intervals to prevent flat tyres from
extended standing.
Note regarding the tyres
• If the product is not moved for several days, permanent
colour changes may occur where it comes into contact
with the surface it is standing on. A suitable surface
must therefore be ensured if the wheelchair is parked
for extended periods of time.
• Tyres contain chemical substances that can react with
other chemical substances (such as cleaning agents,
acids, etc.).
• Black tyres contain soot particles. They may leave black
marks where they come into contact with the ground.
Therefore the manufacturer recommends grey tyres if
the product is primarily used indoors.
Ottobock | 11B400
Delivery

12 | Ottobock B400
• Avoid unnecessary parking outdoors. Direct exposure to
sunlight/UV radiation causes the tyres to age more
quickly. As a result, the tread surface hardens and
corner pieces break out of the tread.
• The tyres must be changed when the tread is less than 1
mm in order to ensure safe driving behaviour.
• The tyres should be replaced every 2 years regardless
of wear and tear.
5 Preparation for Use
5.1 Tools required
The following tools are required to make fine adjust
ments/setting changes:
• Size 2 – 8 mm Allen wrenches
• Size 8 – 24 ring / open-end wrenches
• Size 8 – 20 socket wrenches
• Phillips screwdriver, size 2
• Torque wrench (measurement range 5 – 50 Nm)
5.2 Initial operation
WARNING
Incorrect charging or use of the battery
Risk of injury due to fire or explosion, battery damage,
short circuit
►Observe the safety instructions in the instructions for
use (user), chapter "Usage" > "Batteries/Charging
Process" > "Safety Instructions".
NOTICE
Short circuit
Risk of damage to the electrical/electronic components
►Remove the fuse before performing any work on the
battery.
►Only use insulated tools to perform maintenance work
on the batteries.
►Ensure correct polarity when you connect the battery
cables. Connect the black cable to the negative termin
al and the red cable to the positive terminal.
NOTICE
Insufficient ventilation of the battery charger while
charging
Risk of damage to the battery charger
►Avoid overheating of the battery charger during char
ging.
►Ensure that the cooling fins on the back of the device
are not covered.
Before initial operation of the power wheelchair, the 80-A
safety fuse must be installed in the corresponding fuse hold
er under the seat next to the controller.
Preparation for Use

Ottobock | 13B400
5.2.1 Installing the fuse
1) Remove the fuse from the protective cover.
2) Open the fuse holder cover.
3) Centre the fuse on the spring contacts and plug it in.
4) Close the fuse holder cover until you feel it engage.
Fig. 1 Fuse holder, vertical (basic model); fuse holder, hori
zontal
1 Fuse holder
2 Safety cap
3 Fuse
5.2.2 Charging the battery
See the power wheelchair instructions for use (user) for all
information regarding the charging process.
6 Adjustments
6.1 Prerequisites
WARNING
Incorrect settings
Risk of falling, tipping over or improper user posture due to
incorrect settings
►Adjustments may only be carried out by qualified per
sonnel instructed by the manufacturer.
►Check for safe function before delivering the product.
CAUTION
Unsecured screw connections
Risk of pinching, crushing, tipping over, falling of user
►After all adjusting/readjusting work, retighten the
mounting screws/nuts firmly. Observe any torque set
tings which may be specified.
►Any time you loosen a screw connection with thread
lock, replace it with a new screw connection or secure
the old screw connection with medium strength thread
locker (e.g. Loctite 241®).
Fine adjustments and setting changes to match the concrete
physical and mental condition of the user should always be
made in the user's presence.
All parts of the product should be cleaned thoroughly before
adjustments are made.
Adjustments

14 | Ottobock B400
6.2 Basic Settings
The following fitting tasks are described in more detail in the
included Instructions for Use (User) – reference number
647G945:
• Adjusting the seat
• Adjusting the side panels
• Adjusting the footrests
• Adjusting the belt lengths
• Adjusting the control panel
6.3 Changing control unit parameters
WARNING
Incorrect configuration settings
Falling, tipping over, collision due to programming errors
►Programming may only be performed by qualified per
sonnel trained by the manufacturer. The manufacturer
of the product and the control unit manufacturer are
not liable in case of damage caused by programming
which was not performed properly and/or which was
not adjusted properly according to the user's abilities.
►Note that modified parameter settings in the configura
tion can lead to changes in driving characteristics. In
particular, changes to the speed, acceleration, braking
or joystick settings can lead to unexpected and there
fore uncontrollable driving characteristics and cause
an accident.
►After configuration/programming is complete, the user
must test the driving characteristics of the product
under the supervision of the qualified personnel.
6.3.1 Wheelchair control options
If necessary, the pre-programmed wheelchair control sys
tem can be adjusted to the specific user requirements.
Further information on programming can be found in the
service manual (647G946=DE/647G946=EN)
Information on operation and troubleshooting of the wheel
chair control unit can be found in the instructions for use
(user).
6.3.2 Attendant control
The power wheelchair can be ordered and equipped with an
attendant control. It may be necessary to fit the already
installed attendant control to the actual body size of the
attendant.
The instructions for use (user) contain information on oper
ating the attendant control.
7 Handover
7.1 Final inspection
A final inspection should be performed before delivery of the
power wheelchair:
• Are all options installed according to the order form?
Handover

Ottobock | 15B400
• Was the power wheelchair fitted optimally to the physic
al and mental condition of the user (seat, armrests,
footrests, control panel, additional controls)?
• Are the batteries charged?
• Is the tyre pressure correct (see tyre sidewall for inform
ation)?
• Do all manual and power functions work properly?
• Do all control functions work properly?
• Do the brakes work?
• If intended: Are all options required to take part in road
traffic installed and fully functional (warning triangle,
lights, warning flashers)?
7.2 Transport to the customer
CAUTION
Securing the power wheelchair insufficiently during
transport
Risk of pinching, crushing, blows to body parts
►During transportation in vehicles, on lifting platforms or
in lifts, turn the control unit of the power wheelchair off
and lock the brake.
►The power wheelchair must be secured in accordance
with the regulations for the transport device.
►During transport in another vehicle, the power wheel
chair must be secured sufficiently with cargo straps.
Only attach the cargo straps to the corresponding
transportation eyelets and specified tie-down points.
NOTICE
Improper transport
Risk of damage to the power wheelchair
►Ensure that the seat is lowered all the way and the
backrest is in a vertical position prior to loading and for
transporting the power wheelchair.
►Only use sufficiently large hoisting devices to transport
the power wheelchair (see section "Technical Data" for
the weight of the power wheelchair).
NOTICE
Use of unsuitable packaging
Damage caused by transport in the wrong packaging
►Use only the original packaging for delivery of the
product.
7.2.1 Reducing the transportation size
The instructions for use (user) contain information on redu
cing the transportation size.
Handover

16 | Ottobock B400
7.2.2 Preparing for transport
1) Lift the power wheelchair and place it in its transport
location.
INFORMATION: To lift or carry the power wheel
chair, use the eyebolts in the front and back of the
frame.
2) Turn the control unit off.
3) Engage the brake.
4) Use the eyebolts and cargo straps to attach the power
wheelchair to the transport vehicle.
Fig. 2 Eyebolts
1 Eyebolt, front
2 Eyebolt, rear
7.3 Handover
WARNING
Lack of instruction
Risk of falling, tipping over due to lack of knowledge
►Instruct the user or the attendant in the proper use of
the product when handing it over.
The following steps must be performed for the safe delivery
of the wheelchair:
• Have the user get into the wheelchair and perform a trial
seat fitting. Pay special attention to proper positioning
according to medical considerations.
• The user and any attendants must be instructed in safe
use of the wheelchair. In particular, the enclosed
instructions for use (user) are to be used.
• The instructions for use (user) must be issued to the
user or an attendant during handover of the wheelchair.
• The user should acknowledge that they have been
instructed in how to use the product and were informed
of the residual risks.
8 Maintenance / repair
The manufacturer recommends regular maintenance of the
product every 12 months.
The instructions for use (user) contain further information on
cleaning/disinfection as well as maintenance/repair by the
user.
Maintenance / repair

Ottobock | 17B400
Detailed information on repairs and program
ming/troubleshooting of the control unit can be found in the
service manual.
9 Disposal
9.1 Disposal Information
NOTICE
Disposal of batteries
Pollution due to incorrect disposal
►Observe the information printed on the batteries by the
manufacturer.
►Note that the batteries may not be disposed of as
household waste.
All product components must be disposed of properly in
accordance with national regulations.
9.2 Information on Re-Use
CAUTION
Use of used seat upholstery
Functional and hygiene risks for the skin
►Replace the seat upholstery if the wheelchair is to be
re-used.
The product is suitable for re-use.
Similar to second-hand machines or cars, products that are
being re-used are subject to increased strain. Features and
functions must not change in a way that could endanger
patients or other persons within the product’s lifespan.
Based on market observations and the current state of tech
nology, the manufacturer has calculated that the product
can be used for a period of 5 years, provided that it is used
properly and that the service and maintenance instructions
are observed. Storage times at the dealer or with paying
parties are not included in this period. However, we would
like to emphasise that the product is reliable far beyond this
defined period of time, provided that it is cared for and
maintained properly.
The product must first be thoroughly cleaned and disinfec
ted before it can be re-used. Then the product must be
examined by an qualified specialist to check the condition
and to look for wear and possible damage. All worn and
damaged parts as well as components which do not fit or
are unsuitable for the new user must be replaced.
Detailed information on replacing components as well as
information on the required tools and the prescribed service
intervals can be found in the service manual.
10 Legal Information
10.1 Liability
The manufacturer’s warranty applies only if the device has
been used under the conditions and for the purpose
Disposal

18 | Ottobock B400
described. The manufacturer recommends that the device
be used and maintained according to the instructions for
use.
The manufacturer is not responsible for damages caused by
components and spare parts not approved by the manufac
turer. Repairs must be carried out exclusively by authorised
dealers or by the manufacturer.
10.2 CE Conformity
This device meets the requirements of the 93 / 42 / EEC
guidelines for medical devices. This device has been classi
fied as a class I device according to the classification criter
ia outlined in appendix IX of the guidelines. The declaration
of conformity was therefore created by the manufacturer
with sole responsibility according to appendix VII of the
guidelines.
10.3 Warranty Terms and Conditions
Further information on the warranty terms and conditions is
available from the manufacturer's service (see inside back
cover for addresses).
10.4 Trademarks
All denotations within this accompanying document are sub
ject to the provisions of the respective applicable trademark
laws and the rights of the respective owners, with no restric
tions.
All brands, trade names or company names may be
registered trademarks and are subject to the rights of the
respective owners.
Should trademarks in this accompanying document fail to be
explicitly identified as such, this does not justify the conclu
sion that the denotation in question is free of third-party
rights.
Legal Information

Ottobock | 19B400
11 Appendices
11.1 Technical data
General Information
Type class (according to DIN EN 12184) Wheel combination 14"/9" (Standard): Class B
Wheel combination 12.5"/8" (Option): Class A
Dimensions and weights Standard seat Contour seat
Seat depth 380 – 500mm 360 – 480mm
Seat width 380 – 480mm 380 – 480mm
Seat height 400/450/500mm 470/520/570mm
Lower leg length 250 – 490mm 280 – 540mm
Dimensions and weights
Armrest height (telescoping armrest) 225 - 350 mm; standard seat, junior: 205 - 275 mm
Armrest length (standard) 260mm
Back height (standard seat) 450 mm or 550 mm (depending on the version)
Back angle -9/1/11/21° or 0/10/20/30°
Overall width 580mm
Overall height 1030mm
Total length 1080mm
Weight when empty (basic equipment)1) 95kg
Appendices

20 | Ottobock B400
Dimensions and weights
Transport weights* see weight when empty1), of which:
Side panel: < 1kg
Footrest (standard): approx. 1kg
Footrest (manually elevating): 1.8kg
Max. load capacity
(Permissible user weight)
Wheel combination 14"/9" (Standard): 140 kg
Wheel combination 12.5"/8" (Option): 100 kg
Model with standard seat, junior option: 100 kg
Turning radius 870 mm
Turning circle** 1450mm
Caster wheel tyre size
Drive wheel tyre size
9" (optional: 8")
14" (optional: 12.5")
Tyre pressure see casing
* The specified weights vary according to the selected options and model.
*** = 3-point turn by 180°
Electrical system
IP protection rating (according to DIN EN
60529)
IP44
Operating voltage 24V
Batteries
AGM (Standard)
Gel (Option)
2 x 12V, 50Ah(C5)
2 x 12V, 63Ah(C5)
Appendices