Combination With An Osseointegrated Implant System; Intended Use; Indications For Use; Conditions Of Use - Otto Bock C-Leg 3C98-3 Instructions For Use Manual

Promenade VS2
Body weight
Up to 100 kg (220 lbs)
101 kg to 115 kg (222 lbs to 253 lbs)
Maverik Comfort AT F22
Body weight
Up to 100 kg (220 lbs)
Thrive FS5
Body weight
Up to 100 kg (220 lbs)
RS2-00 Runway, RS2-K1 Runway HX
Body weight
Up to 75 kg (165 lbs)
76 kg to 100 kg (167 lbs to 220 lbs)

2.3.2 Combination with an osseointegrated implant system

This product can be connected to a socket or to an osseointegrated, percutaneous implant system.
In case of connection to an implant system, verify that the manufacturer of the implant system and the manufactur­
ers of the corresponding exoprosthetic components/adapters also permit this combination. It must be ensured that
all indications/contraindications, the field of application, the conditions of use and all safety instructions are com­
plied with for the implant system, corresponding exoprosthetic components, corresponding adapters and for the
knee joint.
Among other things, this relates to the body weight, mobility grade, type of activity, load capacity of the implant and
bone anchoring, freedom from pain under functional load and compliance with the permissible ambient conditions
(see page 48).
Please ensure that the qualified personnel applying the product is not only authorised for fitting this knee joint, but
also for the connection to the osseointegrated implant system.

3 Intended use

3.1 Indications for use

The product is to be used solely for lower limb exoprosthetic fittings.

3.2 Conditions of use

The product was developed for everyday use and must not be used for unusual activities. These unusual activities
include, for example, extreme sports (free climbing, parachuting, paragliding, etc.).
Permissible ambient conditions are described in the technical data (see page 48).
The product is intended exclusively for use on one patient. Use of the product by another person is not approved
by the manufacturer.
Our components perform optimally when paired with appropriate components based upon weight and mobility
grades identifiable by our MOBIS classification information and which have appropriate modular connectors.
The product is recommended for mobility grade 2 (restricted outdoor walker), mobility grade 3
(unrestricted outdoor walker) and mobility grade 4 (unrestricted outdoor walker with particularly
m°
high demands). Approved for a body weight of 136 kg max.
kg

3.3 Indications

• For patients with knee disarticulation, transfemoral amputation or hip disarticulation
• For unilateral or bilateral amputation
• Dysmelia patients with residual limb characteristics corresponding to knee disarticulation, transfemoral ampu­
tation or hip disarticulation
C-Leg 3C98-3/3C88-3
Approved foot size [cm]
Up to 31
Up to 28
Approved foot size [cm]
Up to 28
Approved foot size [cm]
Up to 26
Approved foot size [cm]
Up to 28
Up to 26
Intended use
Maximum stiffness
3
4
Maximum stiffness
7
Maximum stiffness
7
Maximum stiffness
5
4
13