Resting and Stress ECG

Transcription

1 Operating Manual Resting and Stress ECG 1 Safety Hardware 3 Software 4 Hygiene Part : Operating characteristics: 1-channel PC ECG, Resting & stress ECG MHW 001 DK 1713 Version 00 09/05/018

2 018 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: 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 001 DK 1713 Version 00 09/05/018 custo med GmbH [] Resting and Stress ECG Hardware, custo cardio 400 BT page

3 Operating Manual Resting and Stress ECG 1 Safety Hardware 3 Software 4 Hygiene Part : Table of contents.1 Symbols on the devices Intended use Part names, components for the recording Assembly and device operation.4.1 Setting the telescope boom and mounting it on the device trolley Placing the device in the telescope boom Preparing patient leads custo cardio 400 BT device operation Examination procedure Attaching the device to the patient.6.1 Electrode application Instructions for the stress ECG with treadmill Technical data and system requirements Manufacturer's declaration regarding EMC EC Declaration of Conformity List of product components and accessories MHW 001 DK 1713 Version 00 09/05/018 custo med GmbH [] Resting and Stress ECG Hardware, custo cardio 400 BT page 3

4 .1 Symbols on the devices Manufacturer: custo med GmbH, Maria-Merian-Str. 6, 8551 Ottobrunn, Germany Production date (YYYY-MM, e.g ) CE mark, notified body Observe the Operating Manual Medical electrical equipment classification according to DIN EN (Type CF) Non-ionising electromagnetic radiation, Device contains a RF transmitter Separate collection of electrical and electronic equipment, do not dispose with domestic waste Hygiene seal of the German Society of Hospital Hygiene MHW 001 DK 1713 Version 00 09/05/018 custo med GmbH [] Resting and Stress ECG Hardware, custo cardio 400 BT page 4

5 . Intended use custo cardio 400 BT is a 1-channel electrocardiograph with an integrated electrode application system which is used in professional applications as a resting or stress ECG. The electrode application system uses underpressure to attach the electrodes to the body of the patient. The intercardial application is not intended. The terminal lines are R, L and F according to Einthoven and C1 to C6 according to Wilson. custo cardio 400 BT is perfectly safe for patients with a pacemaker. The ECG recording is not affected by pacemaker pulses. The device must be operated by suitably trained and qualified personnel in medical practices, laboratories, rehab centres and hospitals. In particular, these include doctors and medical-technical personnel. The intended use of this device does not include use in home settings, especially by laypersons. MHW 001 DK 1713 Version 00 09/05/018 custo med GmbH [] Resting and Stress ECG Hardware, custo cardio 400 BT page 5

6 .3 Part names, components for the recording custo cardio 400 BT with Bluetooth & USB custo cardio 400 BT ECG application system 6 thoracic wall leads (1.0 m) and 4 extremity leads (1.45 m) Electrode hair, other versions optional Spacer -fold Spacer 3-fold Telescopic boom for custo cardio 400 BT Bracket for telescopic boom Cable hook for electrode leads (not pictured) Bluetooth-USB adapter (Bluetooth 4.0) USB extension cable BT power supply unit for custo cardio 400 BT 1.5 m power cable for power supply unit 3 m USB cable MHW 001 DK 1713 Version 00 09/05/018 custo med GmbH [] Resting and Stress ECG Hardware, custo cardio 400 BT page 6

7 .4 Assembly and device operation.4.1 Setting the telescope boom and mounting it on the device trolley Anti-turn device for fixing the boom, in the open position during operation (70 swivel range) Continuous height adjustment with gas pressure spring Gas pressure spring Extraction lock to extend and pull in the boom arm Bracket for custo cardio 400 BT with safety bar Put the clamps and in position and secure them with an Allen key (size 5 mm). Mount the clamps straight (aligned) to keep the gas pressure spring from jamming. 160 mm 400 mm Use the screw set to fix the bracket to the device trolley, place the boom and protective plastic ring in the bracket, set the swivel range of the boom and then fasten the boom in the bracket. MHW 001 DK 1713 Version 00 09/05/018 custo med GmbH [] Resting and Stress ECG Hardware, custo cardio 400 BT page 7

8 .4. Placing the device in the telescope boom Push custo cardio 400 BT into the bracket on the boom. To do this, pull the safety bar back and push the device into the bracket until it clicks into place so that the safety bar is moved back to the front. Operating the telescope boom safely Follow the instructions below to safely move the device trolley with the telescopic boom: Fasten the telescope boom: Tighten the anti-turn device. Set the angle of the boom arm to 90 degrees: Height adjustment : Press the lever and simultaneously move the boom arm into the desired position by moving the end of the boom arm up or down. To NOT pull the device. Pull the boom arm in completely: extraction lock. Assembling custo cardio 400 BT Attach the USB cable to the device, pull the arm of the boom out until it reaches the maximum length. Route the USB cable along the boom and fix it using the Velcro fasteners. Important: Only connect the USB cable after the installation of the software to the PC. custo cardio 400 BT Power supply line for connection to the power supply unit 1) 1) Note on the power supply: Use only the power supply unit delivered with the device (item number 85037). MHW 001 DK 1713 Version 00 09/05/018 custo med GmbH [] Resting and Stress ECG Hardware, custo cardio 400 BT page 8

9 .4.3 Preparing patient leads Attach the coding labels to the ends of the patient leads. The labels C1 to C6 are glued to the chest wall leads (length: 1.0 m). C3 C C1 The labels R, L, F and N are glued to the longer extremity leads (length: 1.45 m). Connect the patient leads according to the coding on the device. Press the electrodes onto the ends of the electrode leads, until you hear a click. MHW 001 DK 1713 Version 00 09/05/018 custo med GmbH [] Resting and Stress ECG Hardware, custo cardio 400 BT page 9

10 .4.4 custo cardio 400 BT device operation On/off button, for starting processes manually. This is otherwise performed automatically by the software. Status display Suction level control Controls how strongly the electrodes are fixed to the skin of the patient (levels 1 to 6 can be set) Cleaning button for manually blowing out the leads. This is otherwise performed automatically by the software. Status display states: Prerequisites for the use of the device: Proper installation, configuration and commissioning of the system. Turquoise LED = USB mode Blue LED = Bluetooth/WLAN mode Orange LED = Manual recording Green LED = Blow out of the leads Yellow LED = Warning notification Examples of visual feedback from the device during operation Standby mode: The on/off button illuminates in blue State after opening the ECG user interface in custo diagnostic (or manual actuation by pressing the on/off button): The on/off button and suction level control are illuminated in blue, the status display shows the preset suction level in the colour of the connection type, blue for Bluetooth in this case. The suction level can be adjusted manually by pressing the suction level control button. State after ECG recording is exited / when the ECG user interface is closed: When ECG recording is exited, the electrodes are released and the leads are blown out. The on/off button and the cleaning button illuminate in blue, and the status display illuminates for the duration of the blow out. The green status display becomes smaller according to the progression of the blow-out time (if the entire duration of the blow-out time is less than one minute). MHW 001 DK 1713 Version 00 09/05/018 custo med GmbH [] Resting and Stress ECG Hardware, custo cardio 400 BT page 10

11 Recording functions and procedures: Changing the connection type If a USB connection is available, it is prioritised over the wireless connection because of the higher data rate. The connection can only be changed by the device (e.g. from Bluetooth to USB) if a recording is not currently underway. Manual starting and ending An ECG recording can also be started by pressing the on/off button in addition to using the software interface. To do this, open the ECG interface in custo diagnostic and press the on/off button on the device. The status display illuminates in orange, and the ECG recording proceeds according to the custo diagnostic configuration. Recordings without a time limit must be ended by pressing the on/off button again (e.g. rhythm strips). Automatic suction level control To use this function, the suction level must be set to at least level 3 in custo diagnostic. With automatic suction power control, the suction level is increased until the system is airtight and the electrodes rest tightly enough against the skin of the patient. If the suction level is set manually, automatic suction level control is deactivated. Cleaning the electrode leads The cleaning function should be used regularly, e.g. at the end of every work day. Pressing the cleaning button triggers an extended blows any moisture out of the electrode leads for an extended period of time. The duration is configured in custo diagnostic, factory default: 30 minutes. After the cleaning, the device switches to standby mode. Device warnings If there is a technical problem, the status display illuminates in red. Further information can be found in the custo diagnostic error log file. Contact your authorised custo med dealer. Resetting the Bluetooth connection At commissioning or if the device is deployed in mobile applications, the existing Bluetooth connection may need to be reset (e.g. to allow the device to connect to a different work station). To do this press the + and - buttons simultaneously for approx. seconds. The device turns off briefly. Figure: USB connection, status display changes from blue (wireless connection) to turquoise (USB connection) Figure: Starting a recording manually, status display orange MHW 001 DK 1713 Version 00 09/05/018 custo med GmbH [] Resting and Stress ECG Hardware, custo cardio 400 BT page 11

12 .5 Examination procedure Prerequisites for an inspection: Proper installation, configuration and commissioning of the system. 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. Start custo diagnostic and click: Examination, Resting ECG, New Resting ECG see Software description.... Spray the contact spray 1) on the electrode application points. Place the electrodes on the patient according to the placement diagram, See.6.1 Electrode application. Start the recording. The patient must keep still during the recording process. Stress test 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 the patient is in the optimal seating position (the extended leg should be slightly bent). When using a treadmill, make sure to follow the instructions in.6. Instructions for stress ECG with treadmill. Start custo diagnostic and click: Examination, Stress ECG, New Stress ECG see Software description.... Spray the contact spray 1) on the electrode application points. Place the electrodes on the patient according to the placement diagram, See.6.1 Electrode application. Wait some minutes so that the contact between the skin and the electrodes can develop optimally. Apply the blood pressure cuff. Start the recording. 1) Contact spray warning Before each examination, make sure to spray contact spray on the electrode application points. Never spray the contact spray onto the electrodes or into the electrodes or leads. Do not use water or contact gel! Recommended contact sprays from: C+V Pharma Depot GmbH or GE Medical Systems Only use recommended contact sprays. Residues from other products can damage the custo cardio 400 BT electrodes. MHW 001 DK 1713 Version 00 09/05/018 custo med GmbH [] Resting and Stress ECG Hardware, custo cardio 400 BT page 1

13 Resting and Stress ECG.6 Attaching the device to the patient.6.1 Electrode application 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 R L F N R L F N R L F N Extremities resting ECG red right arm yellow left arm green left leg black right leg Stress ECG (lying or standing): extremities red on the right below the collarbone yellow on the left below the collarbone green on the left above the hip black on the right above the hip Stress ECG (sitting position): extremities red attach to the deltoid muscle on the right yellow attach to the deltoid muscle on the left green 9. Left rib black 9. Right rib MHW 001 DK 1713 Version 00 09/05/018 custo med GmbH [] Resting and Stress ECG Hardware, custo cardio 400 BT page 13

14 .6. 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. 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 001 DK 1713 Version 00 09/05/018 custo med GmbH [] Resting and Stress ECG Hardware, custo cardio 400 BT page 14

15 .7 Technical data and system requirements custo cardio 400 BT Number of ECG channels 1 Frequency response 0 to 0.6 * sampling frequency [HZ] Sampling frequency 1000, 000, 4000, 8000, (only with USB), 3000 (only with USB) Hz Sampling rate Identical for all channels, possible settings: 1.0 ms / 0.5 ms / 0.5 ms / 0.15 ms / ms (only with USB) / ms (only with USB) Deviation < 1.5 % A/D converter 4 bit Input impedance > 50 MΩ Amplitude quantification 1.56 μv/bit CMRR > 93 db Impedance measurement 1) at all electrode leads (not N) with automatic quality indication Defibrillation protection Electrical strength 5000 V Recovery time after defibrillation < 5 s Suction power Level 0 = 0 mbar Level 4 = 180 mbar Level 1 = 60 mbar Level 5 = 0 mbar Level = 100 mbar Level 6 = 80 mbar Level 3 = 140 mbar Power supply 1 V power supply unit Maximum power consumption 7 Watt EDV connection USB (3 m) and Bluetooth.1 EDR Radio frequency band Bluetooth.1 EDR: GHz (ISM Band) Radio transmitting power Bluetooth.1 EDR: max. 10 dbm Bluetooth range generally 10 m, depending on ambient conditions Time to standby mode ) after disconnection from USB 30 min last BT communication 30 min last manual configuration 30 min IP protection class IPX0 (not protected from water permeation) Dimensions 50 * 110 * 60 mm (L * W * H) Weight approx. 680 g (device without leads and electrodes) Patient leads approx mm (extremities) approx. 100 mm (chest wall) Operating conditions Temperature +10 C C Air humidity % rh Air pressure hpa Transport and Temperature -0 C C Storage conditions Air humidity % rh Air pressure hpa Classification Device with external power supply, Class IIa according to MDD, Type CF application part Underlying standards DIN EN , DIN IEC ; DIN EN ) Does not apply to Bluetooth devices. ) The pump and value are deactivated in standby mode. Communication via USB/BT as well as manual configuration of the system are still possible. Standby mode is not activated during an ECG recording. MHW 001 DK 1713 Version 00 09/05/018 custo med GmbH [] Resting and Stress ECG Hardware, custo cardio 400 BT page 15

16 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 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 MB for 4-hour ECG Hardware & ports DVD or CD-ROM drive, USB port MHW 001 DK 1713 Version 00 09/05/018 custo med GmbH [] Resting and Stress ECG Hardware, custo cardio 400 BT page 16

17 Recommended system requirements Computer Intel Core i3-cpu with HD graphics 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 001 DK 1713 Version 00 09/05/018 custo med GmbH [] Resting and Stress ECG Hardware, custo cardio 400 BT page 17

18 .8 Manufacturer's declaration regarding EMC (electromagnetic compatibility) according to DIN EN :016 Lead lengths Patient leads USB cable approx mm (extremities) approx. 100 mm (chest wall) approx mm Manufacturer's declaration electromagnetic emissions The custo cardio 400 BT ECG application system is designed for use in the electromagnetic environment stated below. The customer or user of custo cardio 400 BT should make sure that it is used in such an environment. Emission measurements RF emissions according to CISPR11 Compliance Group 1 Electromagnetic environment - guidelines custo cardio 400 BT uses RF energy only for its internal function. custo cardio 400 BT BT uses the.4 GHz range frequency band to communicate with the PC. Its level of RF emission is therefore very low and is unlikely to be sufficient to interfere with other electronic devices. RF emissions according to CISPR11 Harmonics according to IEC Voltage fluctuations/flickers according to IEC Class B Class A Complies custo cardio 400 BT 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 400 BT ECG application system is designed for use in the electromagnetic environment stated below. The customer or user of custo cardio 400 BT should make sure that it is used in such an environment. Immunity tests Static electricity discharge (ESD) according to IEC Quick transient electric interference factors / bursts according to IEC Surges according to IEC Voltage drops, brief interruptions and fluctuations in supply voltage according to IEC Magnetic field at supply frequency (50/60 Hz) according to IEC IEC test level ± 8 kv contact discharge ± 15 kv air discharge ± kv for net wires ± 1 kv for input and Output leads (SIP/SOP) ± 1 kv lead against lead ± kv lead against end < 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) < 5 % U T for 5 s (> 95 % drop) 30 A/m Compliance level ± 8 kv contact discharge ± 15 kv air discharge ± kv for net wires ± 1 kv for input and Output leads (SIP/SOP) ± 1 kv lead against lead ± kv lead against end < 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) < 5 % U T for 5 s (> 95 % drop) 30 A/m COMMENT: U T is the alternating supply voltage prior to application of test levels MHW 001 DK 1713 Version 00 09/05/018 custo med GmbH [] Resting and Stress ECG Hardware, custo cardio 400 BT page 18

19 Manufacturer s declaration electromagnetic immunity The custo cardio 400 BT ECG application system is designed for use in the electromagnetic environment stated below. The customer or user of custo cardio 400 BT should make sure that it is used in such an environment. Immunity tests IEC test level Compliance level Conducted disturbances, induced by high-frequency fields according to IEC V effective value 0.15 MHz to 80 MHz 3 V effective value 0.15 MHz to 80 MHz 6 V effective value in ISM frequency bands 1) between 0.15 MHZ and 80 MHz 80% AM at 1 khz 6 V effective value in ISM frequency bands 1) between 0.15 MHZ and 80 MHz 80% AM at 1 khz Radio-frequency electromagnetic fields according to IEC V/m 80 MHz to.7 GHz 80 % AM at 1 khz 10 V/m 80 MHz to.7 GHz 80 % AM at 1 khz 1) The ISM bands (EN: Industrial, Scientific and Medical, i.e. frequency bands used for industrial, scientific and medical purposes) between 0.15 MHz and 80 MHz are to MHz; MHz to MHz; MHz to 7.83 MHz; and MHz to MHz. The amateur radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to.0 MHz; 3.5 MHz to 4.0 MHz; 5.3 MHz to 5.4 MHz; 7 MHz to 7.3 MHz; 10.1 MHz to MHz; 14 MHz to 14. MHz; MHz to MHz; 1 MHz to 1.4 MHz; 4.89 MHz to 4.99 MHz; 8 MHz to 9.7 MHz and 50 MHz to 54.0 MHz. COMMENT on the table Row : Applies for all other connections (patient leads, power supply unit, USB cable) Row 3: Applies for the custo cardio 400 BT housing General COMMENT: With 80 MHz and 800 MHz the higher frequency range is valid. General 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 001 DK 1713 Version 00 09/05/018 custo med GmbH [] Resting and Stress ECG Hardware, custo cardio 400 BT page 19

20 Recommended protective distances between portable and mobile RF telecommunication devices and custo cardio 400 BT custo cardio 400 BT is designed for use in an electromagnetic environment in which the RF transients can be controlled. The user can help avoid electromagnetic interference by maintaining the minimum distance between portable and mobile RF telecommunication devices (transmitters) and the device depending on the power output of the communication device, as indicated below. WARNING: Wearable RF communication devices (radio devices) (including their accessories, e.g. antenna cables and external antennas) should not be used at distances of less than 30 CM (1 inches) from the custo cardio 400 BT parts and leads described by the manufacturer. Failure to observe this warning can compromise the performance of the device. WARNING: Use of this device directly next to other devices or stacked together with other devices should be avoided, as this could result in fault operation. If the devices must nonetheless be used as described above, this device and the other devices should be monitored to ensure proper functionality. Frequency band a) MHz Radio service a) Maximum output in W Clearance in m Immunity test level in V/m 380 to 390 TETRA to 470 GMRS 460, FRS to 787 LTE Band 13, to 960 GSM 800/900, TETRA 800, iden 80, CDMA 850, LTE Band to 1990 GSM 1800, CDMA 1900, GSM 1900, DECT, LTE Band 1, 3, 4, 5, UMTS to 570 Bluetooth, WLAN b/g/n RFID 450, LTE Band to 5800 WLAN a/n COMMENT: If necessary, the clearance between the transmission antenna and the ME system can be reduced to 1 m until the immunity test level is reached. The 1m testing clearance is permitted as per IEC a) For some radio services, on the frequencies for the radio connection of mobile communication devices to the base station (uplink) were included in the table. COMMENT on protection clearances: The minimum clearances for increased immunity test levels must be calculated using the following equation: where P is the maximum output in Watt (W), d the minimum clearance in metres (m) and E the immunity test level in Volt per metre (V/m). General COMMENTS: With 80 MHz and 800 MHz the higher frequency range is valid. 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 001 DK 1713 Version 00 09/05/018 custo med GmbH [] Resting and Stress ECG Hardware, custo cardio 400 BT page 0

21 .9 EC Declaration of Conformity MHW 001 DK 1713 Version 00 09/05/018 custo med GmbH [] Resting and Stress ECG Hardware, custo cardio 400 BT page 1

22 MHW 001 DK 1713 Version 00 09/05/018 custo med GmbH [] Resting and Stress ECG Hardware, custo cardio 400 BT page

23 .10 List of product components and accessories Set no. Set name Part no. Qty. Set/product designation custo cardio 400 BT custo cardio 400 BT ECG application system Thoracic wall leads (1.0 m) Extremity leads (1.45 m) 8507 pck. electrode hair 8503 Spacer -fold Spacer 3-fold Telescopic boom for custo cardio 400 BT with velcro fasteners and hex key Bracket for telescopic boom Cable hook for custo cardio 400 BT Bluetooth 4.0 USB adapter LM m USB extension cable connector A power outlet A BET 061M power supply unit for custo cardio 400 BT Black 1.5 m power supply cable for power supply unit m USB cable for custo cardio 400 BT Accessories Part no. Set/product designation 8507/Z Electrode hair (bag of 10 pieces) 85064/Z Electrode standard (bag of 10 pieces) 85065/Z Electrode small (bag of 10 pieces) 85035/z Extremity lead (1.45 m) 85034/z Thoracic wall leads (1.0 m) Extra long suction lead (1.65 m) 8503 Spacer -fold Spacer 3-fold 85036/z Coding set (1 sheet of 10 pieces) Cable hook for custo cardio 400 BT Telescopic boom for custo cardio 400 BT with velcro fasteners and hex key Short telescopic boom (for custo easy plus device trolley) Bracket for telescopic boom including fixtures Universal bracket for custo cardio 400 BT Wall mounting set for custo cardio 400 BT BT 061M power supply unit for custo cardio 400 BT Black 1.5 m power supply cable for power supply unit m USB cable for custo cardio 400 BT Nano Bluetooth USB adapter custo power station for device trolley Clamp adapter with socket 4 mm for connection to patient simulator (5 pcs.) Adapter for patient simulator (10 pcs.) MHW 001 DK 1713 Version 00 09/05/018 custo med GmbH [] Resting and Stress ECG Hardware, custo cardio 400 BT page 3

24 Manufacturer's contact details: custo med GmbH Maria-Merian-Straße Ottobrunn Germany Phone: +49 (0) Fax: +49 (0) info@customed.de Internet: