User Manual kardiomed cycle 200 med
Version 1.0
Seite 13 von 15
Clean the parts of the seat post and seat sleigh with silicone spray and wipe it dry afterwards.
Check the pedal straps for damages.
Only use original spare parts, therefore please contact us.
Warning: Retorque cranks and pedals
After the first 10 hours in usage the cranks and pedals need to get retorqued.
If they don´t get retightened, damage of the axis, pedals or cranks is possible and the warranty doesn´t
cover the damage.
6.3
Maintenance for authorised specialists
According to the transposition of the medical device directive 93/42 EEC into national law, emotion fitness calls
for a maintenance check with examination of all relevant component parts by an authorized employee/partner.
This maintenance check needs to be conducted
every 12 months
on all medical devices of emotion fitness. For
all necessitated control steps please also consider your countries local requirements.
6.4
Performance of the metrological control pursuant Medical Devices Operator Ordinance
Medical products have to undergo a technical measurement check every
24 months
. The date of the next
control is shown on the control badge, which you will find next to the type plate.
The possible calibration in the course of the technical measurement check can only get performed by an
authorised company or professional. Contact your dealer in case you need a reference.
6.5
Conduction of a safety-related control (According to the transposition of the medical device directive
93/42 EEC into national law)
At all medical training devices a technical safety check has to be conducted at least every 12 months and after
repair by an authorized employee or partner. This check needs to also include the control of the measurement
functionalities (speed and pulse) and all safety-relevant components.
The conduction of the Maintenance, Safety-Related Controls and Metrological Controls is in the sole
responsibility of the operator!
§ 2 subparagraph 2: This law also applies to the use, operation and maintaining of products that have not been
placed on the market as a medical device but are being used with the intended purpose of a medical device as
described in the national laws resulting from medical device directive 93/42EEC.
They are regarded as medical devices in terms of the medical device guideline.
7
Technical Data
The information about measurements and weight can vary because of changes.
Measurements
Weight
Max. user weight
106 cm x 65 cm x 139 cm (L/B/H)
64 kg
130 kg
System of resistance: self-powered brake without the external power supply
buffer battery: 3 x AA/ R03/ UM4 – mignon cell
range of performance is between 25 and 300 watts/ rpm independent
freewheel: existing
Following EU-guidelines are fulfilled:
DIN EN ISO 20957-1 SA
DIN EN ISO 20957-5 SA
DIN EN 60601-1
2001/95/EG allg. general product safety guideline
93/42/EWG medical product guideline
