Field Of Application; General Safety Instructions; Patient Information - Otto HarmonyP3 4R147 Instrucciones De Uso

2.2 Field of application

Field of application according to the Ottobock MOBIS Mobility System:
Recommended for amputees with Mobility Grade 2 to 4 (restricted outdoor wal-
ker, unrestricted outdoor walker, unrestricted outdoor walker with particularly high
demands).
Approved for a patient weight of max. 125 kg / 276 lbs. A minimum weight of
40 kg / 88 lbs is required to activate the pump.
2.3 Safety instructions

2.3.1 General safety instructions

CAUTION
Health risk as a result of using wrong prosthetic socket. The application of wrong socket
techniques can cause health risks for the patient (increased accumulation of fluid in the resi-
dual limb, e.g. oedemas). The prosthetic socket has to be fabricated following exclusively the
Harmony socket fabrication technique.
NOTICE
Function loss due to mechanical damage. If the Functional Ring shows any signs of damage,
proper operation of the device cannot be ensured (impossible to create an elevated vacuum).
The Functional Ring is to be protected against mechanical damage. The Functional Ring must
be replaced by qualified personnel if it shows any signs of damage (see Sections 4.5 and 5).
NOTICE
Function loss as a result of improper use. The patient should be properly instructed in the use
of the Harmony Pump and Harmony System (see Section 2.3.2).

2.3.2 Patient information

Please pass this information on to your patients.
NOTICE
Function loss as a result of dirty valves. Proper maintenance and care require periodic flus-
hing 30-60 ml (1-2 fl-oz) of distilled water with about 5 to 10 pumps/steps through the Harmony
System in order to clean the valves. If flushing does not solve the issue the plastic valves (4Z106
straight & 4Z108 elbow) can be easily replaced (see figure 8).
INFORMATION
• Handle the Harmony Pump carefully and examine regularly for any signs of damage and wear.
• Work with your prosthetist to make sure you understand how the Harmony System feels when
functioning properly, when loss of vacuum occurs and what the overall effects of applying an
elevated vacuum to the limb are.
14 | Ottobock
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