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2 Definitions

16 |

16

201000401000 / Rev 04

2.3.4

Biocompatibility

The system components described in these instructions for use, including accessories, that come 
into contact with the patient during the intended use, meet the biocompatibility requirements of 
the applicable standards. If you have questions in this matter, please contact ergoline or one of 
their representatives.

2.4 Responsibility of the Manufacturer

The manufacturer is responsible for the results with respect to safety, reliability and performance 
only if the following conditions are met:

• Assembly operations, extensions, readjustments, modifications or repairs are carried out by per-

sons authorized by ergoline.

• The electrical installation of the relevant room complies with the requirements of the applica-

ble standards.

• The system is used in accordance with the operator's manual.
• Information is obtained from ergoline before any devices not recommended in this manual are 

connected to the equipment.

NOTICE

This equipment has been tested and found to comply with the limits for a Class B digital device, 
pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection 
against harmful interference in a residential installation. This device generates, uses and can radi-
ate radiofrequency energy and, if not installed and used in accordance with the instructions, may 
cause harmful interference to radio communications. However, there is no guarantee that inter-
ference will not occur in a particular installation. If this device causes harmful interference to 
radio or television reception, which can be determined by turning the device off and on, the user 
is encouraged to try to correct the interference by one or more of the following measures
• Reorienting or relocating the receiving antenna.
• Increase the distance between the device and the receiver.

Содержание ers2

Страница 1: ...System Manual 201000401000 Version 2020 09 24 Rev 04 English ers2 1 Channel ECG Telemetry System ...

Страница 2: ......

Страница 3: ...rdware or software please let us know and we will correct the issue as soon as possible We reserve the right to modify the design and technical features of the device and are not bound by the information and illustrations provided in this manual All trademarks appearing in this document are trademarks of their respective owners Their protection is acknowledged No part of this manual may be reprint...

Страница 4: ...2 2 201000401000 Rev 04 Manufacturer Distributor ergoline GmbH Lindenstrasse 5 72475 Bitz Germany Tel 49 0 7431 9894 0 Fax 49 0 7431 9894 128 e mail info ergoline com http www ergoline com ...

Страница 5: ...peration Mode 24 3 2 2 Firmware Update 24 3 3 Receiver 25 3 4 Chest Belt 26 3 5 Adapter 27 4 Start up and Preparation 28 4 1 Receiver 28 4 2 1 Channel Transmitter 29 4 2 1 Replacing the Battery of the 1 Channel Transmitter 30 4 2 2 Battery Management of the 1 Channel Transmitter 31 5 Attaching the ECG System to the Patient 32 5 1 Visual Inspection of the ECG System 32 5 2 Applying the 1 Channel Tr...

Страница 6: ...ment 42 7 1 1 Warranty Information 43 7 2 Functional Test 43 7 3 Firmware Update 44 7 4 Troubleshooting 44 8 Disposal 45 9 Technical Specifications 46 9 1 1 Channel Transmitter 46 9 1 1 General Data 46 9 1 2 Electronic System 46 9 1 3 Environment 47 9 1 4 Bluetooth Module 47 9 1 5 Mechanical Data 47 9 2 Application Software ers2 48 9 3 Receiver 48 9 3 1 Summary 48 9 4 Chest Belt 49 9 4 1 Summary 4...

Страница 7: ...and later telemetry firmware version 5 0 added ECG system information added information to technical data update of intended use information 2019 02 19 03 ers2 software version 2 00 and later telemetry firmware version 5 0 and later ECG telemetry transmitter hardware version STR12 and later added new firmware functionalities added ECG chest belt information added ECG system maintenance information...

Страница 8: ...6 6 201000401000 Rev 04 ...

Страница 9: ...h product training it should rather be considered as a supple ment The symbol means Follow instructions in accompanying documents It indicates points that are of particular importance in the application of the device The manual reflects the device specifications and applicable safety standards valid at the time of printing All rights are reserved for devices circuits techniques software programs a...

Страница 10: ...sembly of ME systems and modifications during their actual operating life require the verifi cation of compliance with the requirements for electrical safety and of the essential performance The manufacturer and the competent authority of the member state where this ECG system is used must be notified of all serious incidents involving the system which directly or indirectly led or may lead to dea...

Страница 11: ...ne English ETS ECG system ETS1 1 channel system ETS1 Transmitter 1 channel transmitter ETS1 Adapter adapter ETS1 Chestbelt chest belt ETS Receiver receiver Signal Word Meaning DANGER Indicates an imminent risk that if not avoided can result in death or seri ous injury Not used in this manual WARNING Indicates a potential risk or unsafe practice that if not avoided can result in death or serious in...

Страница 12: ... professional experience related to the product similar products or IT in general No product specific professional experience required specified education is sufficient Core task related to the medical device Prepare patient for ECG monitoring perform follow up tasks cleaning disinfection Replace battery of 1 channel transmitter Equipment typically used to perform the tasks Application software EC...

Страница 13: ...tion facilities Application Applied parts are only used on healthy intact skin The application is transient less than 60 minutes under normal conditions cumulative use for 20 training sessions 2 2 3 Characterization of the Environment of Use The ECG system is intended for use in medical training therapy for inpatient and outpatient care in professional healthcare institutions 2 2 4 Essential Perfo...

Страница 14: ...t exertion level by referring to independent subjective parameters e g the RPE value WARNING Conductive materials Electric shocks or malfunction of the ECG system may result from contact with conductive mate rials Conductive parts of the ECG system must not touch other conductive parts including ground during application to or removal from the patient Follow the sequence of steps for application a...

Страница 15: ...objects being attracted by the magnetic core of the MRI system missile effect Thermal injury and burns may occur due to metal components of the device heating up during MR scanning The system may generate artifacts in the MR image The system may not function properly due to the strong magnetic and radiofrequency fields generated by the MR scanner It is not permitted to use the ECG system in the vi...

Страница 16: ... ECG system Inform your ergoline service partner when you identify or suspect a malfunction NOTICE Safety only with approved accessories applied parts Safe and reliable operation of the ECG system is only possible when the supplied or approved applied parts or accessories are used Observe the appropriate instructions in this manual and the instructions supplied with the applied parts and accessori...

Страница 17: ...net when not in use NOTICE Protection from unauthorized access Switch off the 1 channel transmitter if not used for long periods of time NOTICE Protection from unauthorized access Inform your ergoline service partner if a 1 channel transmitter is stolen or lost WARNING Malfunction of the ECG system Use of portable telephones or other RF devices near the ECG system may cause unexpected or adverse o...

Страница 18: ...h the operator s manual Information is obtained from ergoline before any devices not recommended in this manual are connected to the equipment NOTICE This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation...

Страница 19: ...eign objects such as hands and fingers dust unintentional contact and liquids The first digit 4 indicates the protection against solid for eign objects in this case the protection against ingress of objects with a diame ter of 1 0 mm and more The second digit 2 indicates the protection against ingress of liquids in this case the protection against vertically falling drops when the enclosure is til...

Страница 20: ...part 15 of the FCC rules Operation is subject to the following two conditions 1 This device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired opera tion Follow instructions in accompanying documents Read and understand the instructions for use before using the device or product This is a mandatory sign identif...

Страница 21: ...are Keep dry Indicates that the product package needs to be protected from rain and other sources of moisture Air humidity limitations Indicates the upper and lower limits of air humidity The limit values are indi cated next to the upper and lower horizontal lines Atmospheric pressure limits Indicates the upper and lower atmospheric pressure limits The limit values are indicated next to the upper ...

Страница 22: ...fective sealing ring is identified during visual inspection Replacement by primary user Chest belt erg705 693 Spare part if a defect is identified during visual inspection Replacement by primary user Adapter erg161 831 Spare part if a defect is identified during visual inspection Replacement by primary user 3 1 Information on Product and Packaging This section describes the labels and type plates ...

Страница 23: ...nnel ECG Telemetry System 21 201000401000 Rev 04 Picture Label Location Type plate Back of the 1 channel transmitter Type plate Inside of the adapter Type plate Sewed on elastic chest belt Type plate Underside of the receiver ...

Страница 24: ...kage containing 1 channel transmitter kit chest belt Label Package containing 1 channel transmitter kit adapter Label Package containing receiver Label of individually pack aged adapter within kit Label of individually pack aged chest belt within kit ...

Страница 25: ...e Code structure 1 channel transmitter receiver 01 xxxxxxxxxxxxxx 11 xxxxxx 21 xxxxxxxxxx Adapter 01 xxxxxxxxxxxxxx 10 xxxxxxxxxxxxx 3 2 1 Channel Transmitter Via the applied part the 1 channel transmitter acquires a single channel bipolar raw ECG signal and sends it to a medical application software or other ME equipment by radio transmission The 1 channel transmitter is a type CF defibrillation ...

Страница 26: ...ess than 30 seconds and release LED is illuminated while button is held down Transmitter ON initializing Wait for connection LED continuously flashing twice Transmitter waiting for con nection in normal operation mode Normal mode LED continuously flashing once Transmitter connected in normal operation mode Low battery voltage in nor mal operation mode Replace battery LED continuously flashing thre...

Страница 27: ...de Press On Off button for more than 30 seconds and release LED is illuminated while button is held down Initializing Wait for connection LED continuously flashing 3 short blinks and 2 long blinks Transmitter waiting for con nection in firmware update mode Firmware update mode LED continuously flashing 3 short blinks and 1 long blink Transmitter connected in firmware update mode Low battery voltag...

Страница 28: ...tile chest belt contains two integrated dry conductive polymer electrodes The tex tile chest belt is attached to the 1 channel transmitter by means of snap fasteners A clasp and loop are provided on the end of the belt for fitting the belt to the body Different belt lengths can be adjusted by means of the buckle The chest belt is a type CF defibrillation proof applied part Product description Fron...

Страница 29: ...tical and supplied non sterile This means it may be reused on the same patient if cleaned and disinfected accord ing to instructions The adapter has two ECG leadwires integrated into the cradle The cradle is attached to the 1 channel transmitter by means of snap fasteners The patient wears the adapter on a neckband whose length can be adjusted with the cord stopper The adapter is a type CF defibri...

Страница 30: ...cable Install the receiver driver Check the installation in the Windows Device Manager After starting the PC system the receiver is ready for operation The receiver connects automati cally via the application software to a 1 channel transmitter that has been switched on and con figured appropriately Shutting down the PC system deactivates the receiver and terminates all connections to the 1 channe...

Страница 31: ...itter according to the instructions in this manual for the nor mal operation mode After switch on check the LED status on the 1 channel transmitter to verify the operating status Switch off the 1 channel transmitter according to the instructions in this manual for the normal operation mode After starting the PC system and the application software the activated 1 channel transmitter is ready for op...

Страница 32: ...or shocks When attaching and removing the transmitter or replacing the battery take care not to damage the battery Instructions for proper handling are given in this manual NOTICE Battery replacement closing the cover Screwing the cover too tight may damage the 1 channel transmitter The only part to open on the 1 channel transmitter is the battery compartment Please note that the cover of the 1 ch...

Страница 33: ...compartment of the 1 channel transmitter with the minus pole first Then place the cover on the thread and turn the cover approx one and a half revolution clock wise to close After switch on check the LED status on the 1 channel transmitter to verify the operating status 4 2 2 Battery Management of the 1 Channel Transmitter The 1 channel transmitter is powered from a commercially available recharge...

Страница 34: ... parts according to the cleaning and disinfection instructions in this manual CAUTION Risk of infection The ECG system may only be applied on intact skin e g not over open wounds lesions infected or inflamed areas CAUTION Wet environment There is a risk of burn injuries and insufficient ECG transmission quality The ECG system is not suitable for use in highly wet environments Do not wear it in the...

Страница 35: ...s in this manual CAUTION Insufficient ECG transmission quality If the 1 channel transmitter is not properly applied the ECG data may be incorrect or missing which may lead to inadequate therapy and or over exertion Check the 1 channel transmitter for correct application to the chest belt or adapter and patient according to the instructions in this manual NOTICE Mechanical impact The 1 channel tran...

Страница 36: ...e the chest belt at the sternum by introducing the belt loop into the clasp Adjust the width of the closed belt to the patient s chest by means of the buckle The chest belt should be adjusted to a snug fit so as not to move when the subject is active When the chest belt is adjusted to the correct length position it with the snap fasteners directly under the subject s sternum Figure 2 CAUTION Risk ...

Страница 37: ...tter and the chest belt are connected to each other by means of the inte grated snap fasteners Press the studs of the two snap fasteners on the 1 channel transmitter into the sockets of the snap fasteners on the chest belt until you feel them engage Check that the ergoline logo on the 1 channel transmitter and on the chest belt is presented in the proper orientation Figure 3 After attaching the 1 ...

Страница 38: ...ertion Check the 1 channel transmitter for correct application to the chest belt or adapter and patient according to the instructions in this manual NOTICE Mechanical impact The 1 channel transmitter may be damaged if exposed to strong mechanical impact dropping onto the floor shocks When attaching and removing the transmitter or replacing the battery take care not to damage the battery Instructio...

Страница 39: ...channel transmitter is presented in the proper orientation After attaching the 1 channel transmitter to the adapter switch it on 5 3 2 Applying Adhesive Electrodes Apply the electrodes according to the manufacturer s instructions to the right clavicle middle and the left costal arch at the level of the sixth rib below the pectoral muscle 5 3 3 Attaching the Adapter with the 1 Channel Transmitter t...

Страница 40: ...G electrodes Remove the adapter with the 1 channel transmitter from the patient Carefully remove the ECG electrodes from the patient following the manufacturer s instructions Remove the 1 channel transmitter from the adapter by holding the adapter with one hand and the 1 channel transmitter with the other hand and detaching it horizontally from the snap fasteners integrated in the cradle ...

Страница 41: ...ria or viruses Clean and disinfect the 1 channel transmitter and the applied parts according to the cleaning and disinfection instructions in this manual NOTICE Cleaning and disinfection Wrong cleaning agents or disinfectants or wrong application of these substances may damage the ECG system Use the recommended cleaning agents and disinfectants for cleaning and disinfection Clean and disinfect you...

Страница 42: ...nded cleaning agent Isopropyl alcohol 70 solution IPA Prepare the cleaning solution according to the manufacturer s instructions Dampen a clean cloth with the selected cleaning solution Wring excess liquid from the cloth and squeeze until dry Wipe the exterior surfaces of the adapter until all visible soil has been removed 6 2 2 Disinfection Clean the adapter before disinfecting it Recommended dis...

Страница 43: ...y the wet or dripping wet chest belt and take care not to overstretch it while wet 6 4 Receiver It is recommended to regularly remove dust etc from the receiver 6 4 1 Cleaning Dampen a clean cloth with distilled water Wring excess liquid from the cloth Wipe the exterior surfaces of the receiver Use another clean cloth to dry the surface of the receiver CAUTION Risk of infection Using the chest bel...

Страница 44: ... ergoline or one of the authorized representatives of any required maintenance WARNING Visual inspection before use Before each use visually inspect the ECG system for signs of damage If you detect damage that may result in a hazard to the patient or the operator the ECG system must be repaired before it can be used again Follow the instructions for visual inspection given in this manual NOTICE Ma...

Страница 45: ...he software set the heart rate limits and assign this patient to a training place FT1 3 Low battery check Insert an almost depleted battery in the 1 channel transmitter Switch on the 1 channel transmitter FT1 4 Full battery check Insert a fully charged battery in the 1 channel transmitter Switch on the 1 channel transmitter FT1 5 Check wireless ECG signal transmission Switch on the 1 channel trans...

Страница 46: ...ver the 1 channel trans mitter with your hand Expected result Once the 1 channel transmitter is connected a connection icon appears in the software The connection quality decreases For levels below 40 the icon is red Error Cause 1 channel transmitter cannot be switched on Check the battery charge level Check the contacts in the cover of the battery compart ment If they are bent replace the cover C...

Страница 47: ...ries have to be taken to a collection point They need to be recycled NOTICE Environmental impact Electronic devices and the accessories contain metal and plastic parts After the expiration of their useful life the parts must be disposed of in compliance with the valid waste regulations to pre vent any environmental impact Once the service life of the ECG system has expired it must be disposed of i...

Страница 48: ...x 6 hours of continuous operation Battery charging time 2 5 hours charging current 500 mA 1020 mAh recharge able battery capacity Controls and indicators LED indicators for operating status On Off button Biocompatibility To ISO10993 Respiration leads off sensing and active noise suppression No Defibrillation protection Yes Avg recovery time 5 s Description Data Battery type 1 x HR03 AAA NiMH batte...

Страница 49: ...humidity 10 to 95 no condensation Atmospheric pressure 500 to 1060 hPa Description Data Transmission mode Bluetooth 2 1 EDR class 1 Frequency range 2402 2483 5 MHz ISM band Output power of the 1 channel transmitter max 9 8 dBm Receiver sensitivity min 94 dBm Range Up to 50 m open field Antenna type integrated Maximum antenna gain 0 5 dB Description Dimension Dimensions length 84 mm width 48 mm dep...

Страница 50: ...e 80 BPM increase to 120 BPM max 6 s 80 BPM decrease to 40 BPM max 12 s Time to alarm for tachycardia B1 11 s 0 5 B1 12 s 2 B1 23 s B2 11 s 0 5 B2 12 s 2 B2 16 s To IEC 60601 2 27 Visual alarm Location ers2 software monitoring screen Color Modulation 1 Hz modulation between red and yellow Size 160 23 pixels Monitor resolution 1920 1080 Visual alarm update every 2 min Audible alarm Source PC sound ...

Страница 51: ...lied part Type CF defibrillation protected AC Impedance typical approx 400 Ohm DC offset voltage typical 1 mV Defibrillation overload recovery typical approx 6 mV after 5 s Bias current tolerance 110 mV over 8 hours Combined offset instability and internal noise 50 mV Biocompatibility ISO 10993 Chest belt Textile Snap fastener contacts Nickel plated brass Sensor type Dry electrode Sensor material ...

Страница 52: ...mm D Length of sensor module 270 mm 2 mm E Length of sensor 63 mm 2 mm F Length of center textile 134 mm 2mm G Distance from edge of sensor module to loop end 45 mm 3 mm H Length of loop 15 mm FRONT SIDE C B A BODY SIDE F E H G D Description Data Applied part Type CF defibrillation protected ANSI AAMI EC53 Cord Silicone Cord stopper Plastic Cradle Thermolast K Leadwire M PUR Spring of snap fastene...

Страница 53: ...nd storage conditions Temperature 20 to 65 C Rel humidity 10 to 95 no condensation Atmospheric pressure 500 to 1 060 hPa Description Dimension Permitted Deviation Length of silicone cord 1020 mm 10 mm Length of ECG leadwire 250 mm 15 mm Width of cradle 58 8 mm 1 mm Length of cradle 87 mm 1 mm Distance between snap fastener contacts from center to center 44 5 mm 0 5 mm 115 16 8 0 87 01 47 5 10 25 1...

Страница 54: ...nt specified below It is the responsibility of the customer or user to ensure that the ECG system is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emissions to EN 55011 Group 2 The ECG system must emit electromagnetic energy in order to perform its intended function These emissions may cause interference in nearby electronic equipment RF emissions ra...

Страница 55: ...al environment Surge to EN 61000 4 5 1 kV differential mode 2 kV common mode not applicable Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines to EN 61000 4 11 5 UT 95 dip in UT for 0 5 cycles 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 se...

Страница 56: ...in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propaga...

Страница 57: ...um output power of the communications equipment Rated maximum output power of the 1 channel transmitter W Separation distance according to frequency of transmitter in meters m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 1 0 37 1 1 17 10 3 7 100 11 7 For transmitters rated at a maximum output power not listed above the recommended separation distance d...

Страница 58: ...10 Electromagnetic Compatibility EMC DIN EN 60601 1 2 56 56 201000401000 Version 2020 09 24 Rev 04 English ...

Страница 59: ......

Страница 60: ...ergoline GmbH Lindenstraße 5 72475 Bitz Germany Tel 49 0 7431 98 94 0 Fax 49 0 7431 98 94 128 e mail info ergoline com http www ergoline com ...

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