Resting and Stress ECG

Operating Manual Resting and Stress ECG 1 Safety Hardware 3 Software 4 Hygiene Part : Operating characteristics: 1-channel PC ECG, Resting & stress ECG MHW 0013 - DK 1716 Version 001-3/0/018

018 custo med GmbH This Operating Manual may not be copied in its entirety or in part, duplicated in any form or by any means or translated into another language without the prior written consent of custo med GmbH. The manufacturer reserves the right to change the information in this Operating Manual without prior notice. The current version can be downloaded from our website: www.customed.de. CAUTION: This Operating Manual is part of a modular system consisting of four parts. All four parts must be downloaded from the Internet or from a CD to ensure the Operating Manual is complete. MHW 0013 DK 1716 Version 001 3/0/018 custo med GmbH [] Resting and Stress ECG hardware, custo cardio 300 page

Operating Manual Resting and Stress ECG 1 Safety Hardware 3 Software 4 Hygiene Part : Table of contents.1 Symbols on the devices...4. Intended use...5.3 Part names, components for the recording...6.4 Operating custo cardio 300...7.5 Attaching the device to the patient, applying the electrodes...10.6 Instructions for the recording.6.1 Instructions for the stress ECG with treadmill...11.6. Preparing the patient and the examination procedure...13.7 Technical data and system requirements...14.8 Manufacturer's declaration regarding EMC...........................................16.9 EC Declaration of Conformity...19.10 List of product components and accessories...1 MHW 0013 DK 1716 Version 001 3/0/018 custo med GmbH [] Resting and Stress ECG hardware, custo cardio 300 page 3

.1 Symbols on the device Manufacturer: custo med GmbH, Maria-Merian-Str. 6, 8551 Ottobrunn, Germany (Symbol also on the ECG cables) CE mark Notes in the Operating Manual Separate collection of batteries and electrical and electronic equipment, do not dispose with domestic waste Safety class classification of medical electrical equipment according to DIN EN 60601-1 (type CF, defibrillation protected) Non-ionising electromagnetic radiation, device contains a HF transmitter (the radio unit is only active with Bluetooth models (BT)) Observe the Operating Manual (Symbol only on the adapter cable for the suction system) MHW 0013 DK 1716 Version 001 3/0/018 custo med GmbH [] Resting and Stress ECG hardware, custo cardio 300 page 4

. Intended use custo cardio 300 is a 1-channel PC ECG device designed for the creation, analysis and evaluation of ECG recordings in medical practices and hospitals. The system is intended for use by trained specialist staff or physicians. custo cardio 300 is perfectly safe for patients with a pacemaker. ECG recording is not compromised by pace maker pulses. custo cardio 300 is not suitable for intracardial application. MHW 0013 DK 1716 Version 001 3/0/018 custo med GmbH [] Resting and Stress ECG hardware, custo cardio 300 page 5

.3 Part names, components for the recording Individual components on different custo cardio 300 versions custo cardio 300 Patient cable with clips (long) Patient cable with clips (short) Patient cable with banana plugs Adapter cable for suction system Carrying case for cardio 300 Belt for carrying case USB extension cable USB universal power supply unit custo sensive disposable electrodes Sets and accessories list with item numbers see List of product components. MHW 0013 DK 1716 Version 001 3/0/018 custo med GmbH [] Resting and Stress ECG hardware, custo cardio 300 page 6

.4 Operating custo cardio 300 On/off switch The large black button on the device switches the device on and off. Only switch the device on shortly before starting the recording. After the recording, the device does not need to be switched off. It deactivates automatically after 15 minutes of inactivity. The maximum duration of operation is ten minutes in Bluetooth mode at a sampling frequency of 4 khz. (Four hours in WLAN mode) Afterwards the battery needs to be recharged. If the device is operated in battery mode, the maximum duration of operation is five hours in Bluetooth mode. (1.5 hours in WLAN mode) LED display When the device is switched on, the upper LED indicates the state of charge of the accumulators/batteries. Accumulator mode Green / flashing green: Good / good and charging Yellow / flashing yellow: Medium / medium and charging Red / flashing red: Low / low and charging Battery mode Green: Good Yellow: Medium Red: Low If the LED is red and flashing quickly, the accumulator must be recharged / the battery replaced. The middle LED indicates whether the USB connection is active between the device and the PC. If there is a connection, the LED is illuminated continuously again. If there is no connection, the LED is dark. The lower LED indicates whether the radio connection is active between the device and the PC. It illuminates in blue when the device is in radio mode. The device can then be connected via BT or WLAN (depending on the version) or is already connected. This LED flashes as soon as data is transmitted via radio. If there is no connection, the LED is dark. MHW 0013 DK 1716 Version 001 3/0/018 custo med GmbH [] Resting and Stress ECG hardware, custo cardio 300 page 7

Switching on custo cardio 300 If you touch the capacitive on/off switch on custo cardio 300, all LEDs first start to flash and then the device switches on and can be connected Electrode control After the device is switched on, the LEDs in the LED ring indicate the electrode system quality. If the electrodes are not applied on the patient, all LEDs are illuminated in red. If the electrodes are applied to the patient correctly, they are illuminated in green. The same applies, even without a connection to custo diagnostic. Recording can start. Starting/stopping recording on the device The start/stop and blue LED ring functions depend on the settings in custo diagnostic and only work if the device is connected to custo diagnostic and a patient was already selected for a new recording: An x-second ECG is set in custo diagnostic (x is usually ten seconds). If the start button is then pressed on the device, a ten second recording starts. The blue LED ring indicates the progression of the recording, i.e. it is dark at zero seconds, half illuminates at five seconds and fully illuminated at ten seconds. In custo diagnostic, the ECG recording is configured to be stopped manually. The blue LED ring behaves as described above for the first ten seconds. Afterwards, it illuminates in the reverse order and needs a further ten seconds per additional cycle. The recording can be stopped by pressing. MHW 0013 DK 1716 Version 001 3/0/018 custo med GmbH [] Resting and Stress ECG hardware, custo cardio 300 page 8

Charging the accumulator (accumulator version) The port for the USB charging cable is located on the bottom of custo cardio 300. custo cardio 300 charges automatically if it is connected to a PC which is on (flashing battery symbol). The USB cable can also be charged by connecting it to the power supply unit provided. Changing the batteries (battery version) The battery compartment which hold two micro batteries (AAA) is located on the back of custo cardio 300. Connecting patient cable / suction system connection The ECG connection for the patient cable is located on the top of custo cardio 300. Various cables or the adapter cable for connecting the suction system can be connected here. Only suction systems with an integrated 10 kohm or 100 kohm protective resistor can be connected to the adapter cable. If this is not the case, the defibrillation strength of cardio 300 cannot be ensured. MHW 0013 DK 1716 Version 001 3/0/018 custo med GmbH [] Resting and Stress ECG hardware, custo cardio 300 page 9

.6 Attaching the device to the patient, applying the electrodes Thoracic wall resting and stress ECG, standard according to Wilson V1 (C1) red 4. Intercostal space at the right sternal border V (C) yellow 4. Intercostal space at the left sternal border V3 (C3) green on left-hand side of the 5th rib between C and C4 V4 (C4) brown 5th intercostal space on the left midclavicular line V5 (C5) black on the left-hand side of the anterior axillary line, at the same height as C4 V6 (C6) purple on the left-hand side of the midaxillary line, at the same height as C4 Extremities resting ECG R red right arm L yellow left arm F green left leg N black right leg Stress ECG (lying or standing): extremities R red on the right below the collarbone L yellow on the left below the collarbone F green on the left above the hip N black on the right above the hip Stress ECG (sitting position): extremities R red attach to the deltoid muscle on the right L yellow attach to the deltoid muscle on the left F green 9. Left rib N black 9. Right rib MHW 0013 DK 1716 Version 001 3/0/018 custo med GmbH [] Resting and Stress ECG hardware, custo cardio 300 page 10

.6 Instructions for the recording.6.1 Instructions for stress ECG with treadmill The patient should ideally be wearing running shoes or trainers. The patient should not hold onto the handles of the treadmill during the recording process. This will lead to muscle tension which will affect the ECG signal. Missing skin tension, in interaction with shoulder movement, will increase artefacts in the ECG signal. The extremity leads should if possible be applied on taut skin areas in order to avoid excessive movement artefacts and therefore interference in the other terminal lines. During the ECG recording, the electrode leads must not come into contact with the patient, the treadmill or other objects. Normal electrode application Artefact reduced electrode application Artefact reduced electrode application results in smaller amplitudes in the extremity leads. MHW 0013 DK 1716 Version 001 3/0/018 custo med GmbH [] Resting and Stress ECG hardware, custo cardio 300 page 11

Safe use of treadmills with stress ECG Always set the treadmill so that the patient can safely move on the device. Ensure that the acceleration, speed and inclination of the treadmill are adjusted to the patient s physical constitution, stamina and skill. Observe the manufacturer s safety instructions. Always inform the patient before you change the acceleration, speed or inclination. Otherwise, the patient may become injured, e.g. also due to an unexpected, abrupt stopping or starting of the treadmill. MHW 0013 DK 1716 Version 001 3/0/018 custo med GmbH [] Resting and Stress ECG hardware, custo cardio 300 page 1

.6. Preparing the patient and the examination procedure Resting ECG Make sure that the ECG device is connected to the PC and the power supply to the device is guaranteed. Check that your patient is lying comfortably and is not cold. Shave, clean (e.g. with custo prep ECG cream) and dry the electrode application points thoroughly. Place the electrodes (e.g. custo sensive) on the patient. Connect the patient leads to the electrodes. The patient should not move or talk during the recording process. Next step: Start the recording in custo diagnostic Stress ECG Make sure that the ECG device is connected to the PC and the power supply to the device is guaranteed. When using an ergometer, make sure that patient is in the optimal seating position (the extended leg should be slightly bent). When using a treadmill, observe chapter.6.1 Instructions for stress ECG with treadmill Shave, clean (e.g. with custo prep ECG cream) and dry the electrode application points thoroughly. Place the electrodes (e.g. custo sensive) on the patient. Connect the patient leads to the electrodes. Wait some minutes so that the contact between the skin and the electrodes can develop optimally. Apply the blood pressure cuff. Next step: Start the recording in custo diagnostic MHW 0013 DK 1716 Version 001 3/0/018 custo med GmbH [] Resting and Stress ECG hardware, custo cardio 300 page 13

.7 Technical data and system requirements custo cardio 300 Sampling frequency 1000, 000, 4000, 8000, 16000 (only with USB), 3000 Hz (only with USB), Deviation < 1.5 % Sampling rate Identical for all channels, possible settings: 1 ms, 0.5 ms, 0.5 ms, 0.15 ms, 0.065 ms (USB only), 0.0315 ms (USB only) A/D converter 4 bit Input impedance > 50 MOhm Amplitude quantification 1.55 µv/bit CMRR > 93 db Impedance measurement At all electrode leads (not N) with automatic quality indication Defibrillation protection Electrical strength 5000 V Recovery time after defibrillation < 5 s Voltage supply USB devices USB cable (standard connection to PC) USB/BT devices Lithium-ion accumulator or x AAA batteries USB/WLAN devices Lithium-ion accumulator or x AAA batteries Energy consumption Max. 1.5 Watt IT connection *) USB (cable length.50 m) Bluetooth range generally 10 m, depending on ambient conditions Bluetooth frequency.4 GHz ISM frequency band Software add-ons Mains filter, muscle filter, true wave filter, (custo diagnostic) pace maker detection and measuring Operating conditions Temperature +10 C... +40 C Air humidity 5... 95% rh Air pressure 700... 1060 hpa Transport and storage Temperature +5 C... +45 C conditions Air humidity 30... 93% rh Air pressure 700... 1060 hpa Dimension Size approx. 115 * 75 * 18 mm (L * W * H) Weight approx. 430 g Patient leads approx. 1050 mm (extremities) approx. 700 mm (chest wall) Classification custo cardio 300 USB Protection class II custo cardio 300 USB/BT Device with internal power supply custo cardio 300 USB/WLAN Device with external power supply Class IIa Type CF EN 60601-1 EN 60601--5 1) Does not apply to Bluetooth devices MHW 0013 DK 1716 Version 001 3/0/018 custo med GmbH [] Resting and Stress ECG hardware, custo cardio 300 page 14

General system requirements Operating system Windows 7 SP1 with current updates (3 bit and 64 bit operating system) Windows 8 (3 bit and 64 bit operating system) Windows 8.1 (3 bit and 64 bit operating system) Windows 10 (3 bit and 64 bit operating system) Windows Server 003 (3 bit and 64 bit operating system) Windows Server 008 (3 bit and 64 bit operating system) Windows Server 008 R Windows Server 01 Windows Server 01 R older versions are not supported PC The PC hardware should meet the minimum requirements of the operating system used. Provide additional RAM (1 GB) for custo diagnostic. Please ensure that there is sufficient free space on the hard disk for the custo diagnostic evaluations. The PC must meet the requirements of the safety standard DIN EN 60950 for information technology equipment. File sizes of the evaluations Holter: approx. 15 MB (max. 60 MB) ABPM: approx. 18 KB (max. 51 KB) Holter-ABPM: approx. 0 MB (max. 5 MB) Resting ECG: approx. 00 KB (for an ECG of approx. 10 seconds) Stress ECG: approx. 6 MB (for an ECG of approx. 0 minutes) CPET: refer to stress ECG Spirometry: approx. 50 KB (max. 56 KB) Rehab: approx. 6 MB (for approx. 45 minutes of exercise) MCT: approx. 10 15 MB for 4-hour ECG Hardware & ports DVD or CD-ROM drive, USB port Recommended system requirements Computer Intel Core i3-cpu with HD graphics 4400; 4 GB RAM 56 GB SSD or SSHD (for single-position systems TB HDD) 1 GBit network connection (not for single-position systems) Fanless Dual-DVI (or DP) graphics card (for CPET) Windows 8.1 x64 (PRO version for joining a domain) Ports One USB.0 port per USB device (preferably not USB 3.0) One COM port each for ergometer and treadmills (serial) At least Version 4.0 if Bluetooth is installed otherwise can be deactivated in the BIOS Monitor 0 TFT with DVI or DP port Full HD resolution Dual-TFT for spiroergometry Printer 600 dpi Monochrome (colour recommended for spiroergometry) USB.0 port or network connection PCL-enabled (increases printing speed with the suitable driver) MHW 0013 DK 1716 Version 001 3/0/018 custo med GmbH [] Resting and Stress ECG hardware, custo cardio 300 page 15

.8 Manufacturer's declaration regarding EMC (electromagnetic compatibility) according to DIN EN 60601-1-:007 Cable lengths of the patient leads and the USB cables Patient leads approx. 1050 mm and approx. 700 mm USB cable approx..50 m Manufacturer's declaration electromagnetic emissions The custo cardio 300 ECG device is designed for use in the electromagnetic environment stated below. The customer or user of custo cardio 300 should make sure that it is used in such an environment. Emission measurements HF emissions according to CISPR11 Compliance Group 1 Electromagnetic environment - guidelines custo cardio 300 uses HF energy only for its internal function. Its level of HF emission is therefore very low and is unlikely to be sufficient to interfere with other electronic devices. HF emissions according to CISPR11 Harmonics according to IEC61000-3- Voltage fluctuations/flickers according to IEC61000-3-3 Class B Not applicable Not applicable custo cardio 300 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes. Manufacturer s declaration electromagnetic immunity The custo cardio 300 ECG device is designed for use in the electromagnetic environment stated below. The customer or user of custo cardio 300 should make sure that it is used in such an environment. Immunity tests IEC 60601- test level Compliance level Electromagnetic environment - guidelines Electrostatic discharge (ESD) according to IEC 61000-4- ± 6 kv contact discharge ± 8 kv air discharge ± 6 kv contact discharge ± 8 kv air discharge Floors should be made of wood or concrete or be equipped with ceramic tiles. If the floor is provided with synthetic material, the relative air humidity must be at least 30 %. Fast transient electric interference factors/ bursts according to IEC 61000-4-4 ± kv for net wires ± 1 kv for input and output wires Not applicable The quality of the supply voltage should correspond to that of a typical business or clinical environment. Surges according to IEC 61000-4-5 ± 1 kv push-pull voltage ± kv push-push voltage Not applicable The quality of the supply voltage should correspond to that of a typical business or clinical environment. Voltage drops, short-time interruptions and fluctuations in the supply voltage according to IEC 61000-4-11 < 5 % U T for 0.5 periods (> 95 % drop) 40 % U T for 5 periods (60 % drop) 70 % U T for 5 periods (30 % drop) Not applicable The quality of the supply voltage should correspond to that of a typical business or clinical environment. If the user of custo cardio 300 requires continued function, even if interruptions in the energy supply occur, it is recommended to supply custo cardio 300 from an interruption-free power supply. < 5 % U T for 5 s (> 95 % drop) Magnetic field with supply frequency (50/60 Hz) according to IEC 61000-4-8 3 A/m 3 A/m Magnetic fields with mains frequency should correspond to the typical values of a business and clinical environment. COMMENT: U T is the alternating supply voltage prior to application of test levels MHW 0013 DK 1716 Version 001 3/0/018 custo med GmbH [] Resting and Stress ECG hardware, custo cardio 300 page 16

Manufacturer s declaration electromagnetic immunity The custo cardio 300 ECG device is designed for use in the electromagnetic environment stated below. The customer or user of custo cardio 300 should make sure that it is used in such an environment. Immunity tests IEC 60601- test level Compliance level Electromagnetic environment - guidelines Portable and mobile radio sets should not be used at a closer distance to the device including the leads than the recommended protective distance which is determined according to the equation applicable to the frequency of the transmitter. Recommended protective distance: Conducted HR disturbances 3 V effective value [U 1 ] V d = (3.5/U 1 ) P according to IEC 61000-4-6 150 KHz to 80 Mhz 10 V effective value d = (3.5/E 1 ) P 80 MHz to 800 MHz Radiated HR disturbances 3 V/m 10 V/m d = (7/E 1 ) P 800 MHz to.5 GHz according to IEC 61000-4-3 80 MHz to.5 GHz with P as the nominal power of the transmitter in watt (W) according to the indications of the transmitter manufacturer and d as the recommended protective distance in meters (m). According to an examination on-site a) the field strength of stationary radio transmitters should be inferior to the compliance level b) with regard to all frequencies. In the vicinity of devices carrying the following symbol, interference is possible: COMMENT 1: With 80 MHz and 800 MHz the higher frequency range is valid. COMMENT : These guidelines may not apply in every case. The propagation of electromagnetic variables is influenced by absorptions and reflections of buildings, objects and people. a) The field strength of stationary transmitters, such as e.g. base stations of mobile phones and land mobile radios, amateur radio stations, AM and FM broadcasting as well as television networks cannot be exactly predetermined theoretically. In order to determine the electromagnetic environment regarding the stationary transmitters, a study of the location should be considered. If the measured field strength exceeds the above-mentioned compliance levels at the location where the device is used, the device should be watched in order to prove the intended functions. If unusual performance features are observed, it may be necessary to take additional measures, for example reorienting or relocating the device. b) Within the frequency range of 150 khz to 80 MHz, the field strength should be less than 10 V/m. MHW 0013 DK 1716 Version 001 3/0/018 custo med GmbH [] Resting and Stress ECG hardware, custo cardio 300 page 17

Recommended protective distances between portable and mobile HF telecommunication devices and custo cardio 300 custo cardio 300 is designed for use in an electromagnetic environment in which the HF transients can be controlled. The user can help avoid electromagnetic interference by maintaining the minimum distance between portable and mobile HF telecommunication devices (transmitters) and the device depending on the power output of the communication device, as indicated below. Protective distance depending on the transmitting frequency in m Nominal power of the transmitter 150 khz to 80 MHz 80 MHz to 800 MHz 800 MHz to.5 GHz W d= (3.5/U 1 ) P d= (3.5/E 1 ) P d= (7/E 1 ) P 0.01 0.04 0.04 0.08 0.1 0.11 0.11 0. 1 0.35 0.35 0.70 10 1.11 1.11. 100 3.50 3.50 7.00 For transmitters whose maximum nominal power is not indicated in the above table, the recommended protective distance d can be determined in meters (m), using the equation affiliated with the corresponding column. P is the maximum nominal power of the transmitter in watt (W) according to the indications of the manufacturer of the transmitter. COMMENT 1: With 80 MHz and 800 MHz the higher frequency range is valid. COMMENT : These guidelines may not apply in every case. The propagation of electromagnetic variables is influenced by absorptions and reflections of buildings, objects and people. MHW 0013 DK 1716 Version 001 3/0/018 custo med GmbH [] Resting and Stress ECG hardware, custo cardio 300 page 18

.9 EC Declaration of Conformity MHW 0013 DK 1716 Version 001 3/0/018 custo med GmbH [] Resting and Stress ECG hardware, custo cardio 300 page 19

MHW 0013 DK 1716 Version 001 3/0/018 custo med GmbH [] Resting and Stress ECG hardware, custo cardio 300 page 0

.10 List of product components and accessories Set no. Set name Part no. Qty. Set/product designation 10 custo cardio 300 set 101 1 custo cardio 300 (USB version) 113 1 Neoprene carrying case and belt cardio 300 111 1 USB extension cable 104 custo cardio 300 BT-A set 103 1 custo cardio 300 (Bluetooth and accumulator version) 113 1 Neoprene carrying case and belt cardio 300 111 1 USB extension cable 11 1 USB universal power supply unit 55050 1 Bluetooth adapter (Stick) 106 custo cardio 300 BT-B set 103 1 custo cardio 300 (Bluetooth and battery version) 113 1 Neoprene carrying case and belt cardio 300 111 1 USB extension cable 0033 AAA LR03 Micro 1.5 V batteries 55050 1 Bluetooth adapter (Stick) 115 Patient cable banana plug set 114 1 10-wire patient cable with banana plug for custo cardio 300 40004 1 pck. Blue sensor disposable electrodes 117 Patient cable clip (long) set 116 1 10-wire patient cable with clip (long) for custo cardio 300 40007 pck. custo sensive disposable electrodes 119 Patient cable clip (short) set 118 1 10-wire patient cable with clip (short) for custo cardio 300 40007 pck. custo sensive disposable electrodes MHW 0013 DK 1716 Version 001 3/0/018 custo med GmbH [] Resting and Stress ECG hardware, custo cardio 300 page 1

Manufacturer's contact details: custo med GmbH Maria-Merian-Straße 6 8551 Ottobrunn Germany Phone: +49 (0) 89 710 98-00 Fax: +49 (0) 89 710 98-10 E-mail: info@customed.de Internet: www.customed.de