GERATHERM Ergostik User Manual Download Page 4

User Manual 

Ergostik 

ERGOSTIK_MAN_ENG_V1.2.2_REV01.DOCX 

Page 4 

 

2.

 

Ergostik 

2.1

 

Device description and scope of delivery 

 
The Ergostik device is mainly used for CPET (Cardiopulmonary 
Exercise Testing). This investigation involves submaximal and 
maximal treadmill or bicycle exercise with continuous 
electrocardiographic monitoring and breath by breath determination 
of oxygen uptake and carbon dioxide output as well as spirometry. 
This allows determination of exercise capacity, peak heart rate, 
maximal oxygen consumption, anaerobic threshold, respiratory gas 
exchange ratio, and ventilatory equivalent for oxygen. Maximal 
oxygen consumption is the best indicator of maximal cardiac reserve 
and provides important prognostic information to guide the 
assessment and therapy of patients with heart failure as well as other 
cardiac conditions. 
 
The Ergostik connects via USB to PC and consists of housing with 
integrated electronics, oxygen analyser, carbon dioxide analyzer and 
pump. For the flow measurement the proven Ergoflow flow sensor is 
used. 
The Ergostik runs under the powerful Blue Cherry diagnostic software 
platform. The standard software is capable of measurements 
including CPET and Spirometry as well as Pre/post medication 
investigations and trend analysis. The software contains a powerful 
database for patient and test information. Ergostik together with 
Blue Cherry software has a modular design to allow the addition of 
further options in the future such as MVV or Pulse Oxymetry 
measurements.  
 
The Ergostik is designed with versatility in mind, and can be used in 
many areas including Sport Medicine, Pulmonary Rehabilitation, Pre-
operative assessment and Cardio Pulmonary Exercise Testing. It can 
be operated in a stationary or mobile way. Ergostik is not defined to 
check vital physiologic parameter. The following contraindications for 
CPET testing should be taken into account: Arrhythmia, resting BP 
higher than 180/100, severe respiratory insufficiency and other 
severe organic diseases.  

Summary of Contents for Ergostik

Page 1: ...Ergostik User Manual Version 1 2 2 Date 17th October 2014...

Page 2: ...12 2 3 SECURITY 13 2 3 1 GENERAL SECURITY INFORMATION 13 2 3 1 1 NORMS AND GUIDELINES 14 2 3 1 2 ELECTROMAGNETIC COMPATIBILITY 14 2 3 2 SECURE USE OF THE ERGOSTIK 15 2 3 3 CLEANING AND DISINFECTING T...

Page 3: ...e integrated into even the largest of requirements This document contains important information for the operation of Blue Cherry and Ergostik We strongly recommend reading this manual carefully in ord...

Page 4: ...ith integrated electronics oxygen analyser carbon dioxide analyzer and pump For the flow measurement the proven Ergoflow flow sensor is used The Ergostik runs under the powerful Blue Cherry diagnostic...

Page 5: ...rent export possibilities into Excel and XML Using the standard Microsoft clipboard all charts may be imported into standard software such as MS Word or MS PowerPoint Blue Cherry has a unique report i...

Page 6: ...l for indications for the conduct of the calibration Ambistik including USB Dockingstation 2 1 2 Accessories The following accessories can be purchased from you dealer Component Description Part numbe...

Page 7: ...r face mask Large Medium and Small 10 812 Headgear S for face mask Extra Small and Petit 10 829 Headgear for face mask Pediatric Small and Pediatric Large 10 826 Maskadapter 10 815 Mouthpiece includin...

Page 8: ...Ergostik ERGOSTIK_MAN_ENG_V1 2 2_REV01 DOCX Page 8 2 1 3 Spare parts The following spare parts can be purchased from your dealer Component Description Part number Permapure tube and filter 40 424 O2 S...

Page 9: ...user manual Attention should be paid to this information 2 2 1 Connecting the tubes to the front panel On the front side of the Ergostik device are three connectors for the connection of the pressure...

Page 10: ...ection The double pressure tube and the gas sample tube should be connected to the flow sensor as illustrated in the following illustrations Always ensure the tubes are firmly connected and are not be...

Page 11: ...e with a spare USB connector of the computer while using the provided USB cable Do not connect any tube to the yellow connector on the rear side of the device The maximum allowed pressure at the calib...

Page 12: ...power supply to the rear of the Ergostik then connect the power supply to a suitable power outlet The device can then be switched on using the switch at the rear side of the unit The Ergostik may only...

Page 13: ...dered as training for the medical or technical personnel Before using the equipment users should read and understand this included user manual paying attention to the operating instructions Geratherm...

Page 14: ...EN 60601 1 Medical electrical device DIN EN 60601 1 1 General safety requirements DIN EN 60601 1 2 EMV DIN EN 60601 1 4 Programmable electrical medical devices DIN EN ISO 14971 Risk management DIN EN...

Page 15: ...d close to a patient always ensure a minimum distance of 1 5m between patient and non medical computer systems Flow sensors and pressure tubes must not be cleaned Humidity inside the pressure tube may...

Page 16: ...re are no user serviceable components within the housing Never place the device on uneven or unsecured surfaces Should the device case become damaged the unit should be returned for repair The device...

Page 17: ...d cables are connected properly when using the Spirostik complete together with other devices All connected devices must comply with legal regulations and the total leakage current must not exceed the...

Page 18: ...in patient area and resource B in medical used room Resource A within patient area and resource B in medical used room See remarks below table Resource A within patient area and resource B in a non me...

Page 19: ...th local directives 2 3 6 Product Labelling Example of typical product labelling SN designates the serial number for the device The first 2 digits define the manufacturing year The example 13 shows th...

Page 20: ...se dry environment Application component type BF according to DIN EN 60601 1 Indicates single use device protection type II according to MDD Separate collection of electro and electronic devices IPX0...

Page 21: ...lter After 12 months Replace Oxygen cell and tubing set 2 4 2 Replace Oxygen cell Oxygen measurement is performed using an oxygen analyser based upon the electro chemical principle The Oxygen sensor w...

Page 22: ...ng a sample filter and Nafion drying line integrated into the gas sample tube Both the filter and the Nafion tube should be replaced at regular intervals A new sample tube is transparent but with use...

Page 23: ...be provided by Geratherm Respiratory or an authorized service partner of Geratherm Respiratory Geratherm Respiratory will not accept warranty claims on any unauthorised repairs 3 2 Warranty exclusion...

Page 24: ...0ml s Volume Measurement range Accuracy 0 20L 3 or 50mL O2 Analyser Measurement principle Measurement range Accuracy Resolution T90 Electro Chemical cell 1 100 O2 0 1 0 1 100 ms CO2 Analyser Measureme...

Page 25: ...rt 40 mA 2 4 GHz Measurement range Pulse rate 0 250 1 min Operating conditions Temperature Air humidity 5 C to 40 C 10 to 90 non condensing Storage and Transport conditions Temperature Humidity Explos...

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