Spirometry. Operating Manual. Part 2: Hardware, description of device for custo spiro mobile

Transcription

1 Operating Manual Spirometry 1 Safety Hardware 3 Software 4 Hygiene Part : Operating characteristics: A spirometry testing device for the evaluation of pulmonary function MHW 0009 DK 1690 Version /01/018

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 0009 DK 1690 Version /01/018 custo med GmbH [] Spirometry Hardware, custo spiro mobile page

3 Operating Manual Spirometry 1 Safety Hardware 3 Software 4 Hygiene Part : Table of contents.1 Symbols on the devices Intended use Part names, components for the recording Operating the device Calibration Preparation for measurement, patient instructions Technical data and system requirements Manufacturer's declaration regarding EMC EC Declaration of Conformity List of product components and accessories MHW 0009 DK 1690 Version /01/018 custo med GmbH [] Spirometry Hardware, custo spiro mobile page 3

4 .1 Symbols on the devices custo spiro mobile pulmonary function testing device Manufacturer: custo med GmbH, Maria-Merian-Str. 6, 8551 Ottobrunn, Germany CE mark It is recommended to consult the Operating Manual Safety class classification of medical electrical equipment according to DIN EN (Type BF) Separate collection of electrical and electronic equipment, do not dispose with domestic waste custo spiro mobile measuring head Manufacturer: custo med GmbH, Maria-Merian-Str. 6, 8551 Ottobrunn, Germany Observe and follow the Operating Manual (especially cleaning and disinfection) custo spiro protect bacterial and viral filter: CE mark Single-use article Observe and follow the Operating Manual (especially cleaning and disinfection) MHW 0009 DK 1690 Version /01/018 custo med GmbH [] Spirometry Hardware, custo spiro mobile page 4

5 . Intended use custo spiro mobile is a pulmonary function testing device designed for measuring and evaluating a patient's pulmonary function. custo spiro mobile measures respiratory flow rates and lung volumes and displays them graphically in the software interface. The type and status of a lung disease can be diagnosed on the basis of the derived measured values. The quality of the evaluation depends largely on the patient's cooperation. custo spiro mobile is perfectly safe for patients with a pacemaker undergoing examination. Operators must decide themselves whether to use custo spiro mobile in certain situations (e.g. in the case of disablement). The system is intended for use by trained specialist staff or physicians in clinics and medical practices. MHW 0009 DK 1690 Version /01/018 custo med GmbH [] Spirometry Hardware, custo spiro mobile page 5

6 .3 Part names, components for the recording custo spiro mobile Measuring head for custo spiro mobile Adapter for custo spiro mobile (67 mm) Nose clip (not depicted) custo spiro protect bacterial and viral filter Calibration pump 3l MHW 0009 DK 1690 Version /01/018 custo med GmbH [] Spirometry Hardware, custo spiro mobile page 6

7 .4 Operating the device Function display The LED in the handhold of the device lights up when custo spiro mobile is connected to the PC. The device is ready for use. Function display illuminated when custo spiro mobile is ready for use USB cable for the connection to the PC Using the bacterial and viral filters custo spiro protect bacterial and viral filters are fitted to the mouthpiece before measurement. A filter is only to be used for a single patient and, after the examination, it must be disposed of in a safe and environmentally responsible manner. Disassembling and assembling the device To disassemble the custo spiro mobile, press firmly on the release key and detach the measuring head upwards. Pull the mouthpiece from the measuring head by rotating it slightly. When assembling, make sure that the measuring head and handhold engage. MHW 0009 DK 1690 Version /01/018 custo med GmbH [] Spirometry Hardware, custo spiro mobile page 7

8 .5 Calibration Calibration intervals The custo spiro mobile pulmonary function testing devices are pre-calibrated at custo med (10-stage calibration). If putting the device into operation on site, only a calibration as described in this chapter is required. Before using the device for the first time, a calibration must be carried out. In the event of mechanical impact, a calibration must be carried out immediately in order to check the functioning and precision of the pulmonary function testing device. If the pulmonary function testing device is used in conjunction with custo spiro protect bacterial and viral filters, daily calibration is not required. The use of custo spiro protect bacterial and viral filters reduces the need for cleaning and disinfection and, as a result, the formation of deposits in the measuring head. Deposits in the measuring head may falsify the measurement data obtained.if you suspect that there has been a drop in the quality of your measuring results (e.g. all measured values are significantly above the predicted values), carry out a calibration. If you own a calibrated calibration pump, you can carry out the calibration yourself. Otherwise please contact your authorised custo med dealer. Calibration pumps are available as accessories. Instructions for performing calibration Using a non-calibrated device will falsify the measurement data obtained. To ensure correct results, a calibration essential. Calibration is to be performed without a custo spiro protect bacterial and viral filter. Only use calibrated calibration pumps. The best results can be achieved by using l or 3l pumps. 1l pumps may result in inaccuracies. For calibration make sure to specify the correct pump volume. An incorrect pump volume will result in an incorrect calibration and falsify the measurement data obtained. MHW 0009 DK 1690 Version /01/018 custo med GmbH [] Spirometry Hardware, custo spiro mobile page 8

9 .6 Preparation for measurement, patient instructions custo spiro mobile Check to make sure that custo spiro mobile is connected to the PC. When the LED in the handhold is illuminated, the device is ready for use. Fit a new custo spiro protect bacterial and viral filter. Patient During the measurement the patient must sit upright (or stand). The patient must position the mouthpiece of the testing device as follows: The teeth are placed on the mouthpiece and the tongue is located below the mouthpiece. The lips must enclose the mouthpiece firmly. No air may escape from the corners of the mouth during the measurement. Before starting, explain the breathing manoeuvre to the patient and encourage the patient verbally to participate in the procedure! Use short, clear instructions: such as BREATHE IN - FURTHER - FURTHER - BREATHE OUT... Precise instructions serve to improve the quality of the measurement. The quality of the evaluation depends largely on the patient's cooperation. Put the nose clip on the patient just before commencing the measurement. Performing a breathing manoeuvre The patient must start by taking a few quiet breaths. During the last quiet breath before the actual breathing manoeuvre the patient must exhale as deeply as possible (signal tone and system indication). Next the patient must inhale as deeply as possible, if necessary holding his/her breath (max. 1 second) and then exhale again as deeply as possible. During the measurement the patient must sit upright or stand. Ensure the patient's upper body is not bent forward otherwise the measurement data obtained will be falsified. After taking the last breath the patient can put the device down again. MHW 0009 DK 1690 Version /01/018 custo med GmbH [] Spirometry Hardware, custo spiro mobile page 9

10 .7 Technical data and system requirements Technical data Measuring sensor Differential pressure gauge with laminar element Display of measured values BTPS (Body Temperature Pressure Saturated) Measuring range ± 14 l/s Detection of breathing at rest > 300 ml Detection of the end of measurement < 150 ml/sec for 5 sec Resolution 1 bit Accuracy ISO 3747 Linearity < 5% Air resistance < 35 kpa / l/s at 14 l/s Power supply Via USB (Universal Serial Bus) Power supply Standard USB port on the PC Operating conditions Temperature +10 C C Air humidity % rh Air pressure hpa Transport and storage Temperature -0 C C conditions Air humidity % rh Air pressure hpa Dimension Size 140 * 150 * 45 mm (L * W * H) Weight approx. 330 g Classification Safety class II Type BF MDD class IIa Applied standards DIN EN Bacterial and viral filter Single use Filter class H13 (HEPA, 99.95%) Manufactured according to DIN EN 18-1 Tested according to DIN EN ISO MHW 0009 DK 1690 Version /01/018 custo med GmbH [] Spirometry Hardware, custo spiro mobile page 10

11 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 sec.) Stress ECG: approx. 6 MB (for an ECG of approx. 0 min.) CPET: refer to stress ECG Spirometry: approx. 50 KB (max. 56 KB) Rehab: approx. 6 MB (for approx. 45 min. of exercise) MCT: approx MB for 4-hour ECG Hardware & ports DVD or CD-ROM drive, USB port MHW 0009 DK 1690 Version /01/018 custo med GmbH [] Spirometry Hardware, custo spiro mobile page 11

12 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 CPET) USB.0 port or network connection PCL-enabled (increases printing speed with the suitable driver) MHW 0009 DK 1690 Version /01/018 custo med GmbH [] Spirometry Hardware, custo spiro mobile page 1

13 .8 Manufacturer's declaration regarding EMC (electromagnetic compatibility) according to DIN EN :007 Length of USB cable: 3 m Manufacturer's declaration electromagnetic emissions The custo spiro mobile pulmonary function testing device is designed for use in the electromagnetic environment stated below. The customer or user of custo spiro mobile should make sure that it is used in such an environment. Emission measurements RF emissions according to CISPR11 RF emissions according to CISPR11 Harmonics according to IEC Voltage fluctuations/flickers according to IEC Compliance Group 1 Class B Not applicable Not applicable Electromagnetic environment - guidelines custo spiro mobile uses RF energy only for its internal function. Its level of RF emission is therefore very low and is unlikely to be sufficient to interfere with other electronic devices. custo spiro mobile 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 spiro mobile pulmonary function testing device is designed for use in the electromagnetic environment stated below. The customer or user of custo spiro mobile should make sure that it is used in such an environment. Immunity tests Electrostatic discharge (ESD) according to IEC IEC test level Compliance level ± 6 kv contact discharge ± 8 kv air discharge Electromagnetic environment - guidelines ± 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 Surges according to IEC ± kv for net wires ± 1 kv for input and output wires ± 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. 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 < 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) 10 A/m Not applicable The quality of the supply voltage should correspond to that of a typical business or clinical environment. If the user of custo spiro mobile requires continued function, even if interruptions in the energy supply occur, it is recommended to supply custo spiro mobile from an interruption-free power supply. Magnetic field with supply frequency (50/60 Hz) according to IEC A/m Magnetic fields with the mains frequency should correspond to the typical values, as they can be found in a business and clinical environment. COMMENT: U T is the alternating supply voltage prior to application of test levels MHW 0009 DK 1690 Version /01/018 custo med GmbH [] Spirometry Hardware, custo spiro mobile page 13

14 Manufacturer s declaration electromagnetic immunity The custo spiro mobile pulmonary function testing device is designed for use in the electromagnetic environment stated below. The customer or user of custo spiro mobile should make sure that it is used in such an environment. Immunity tests IEC 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 RF disturbances according to IEC V effective value 150 KHz to 80 Mhz U 1 = 3 V effective value d = (3.5/U 1 ) P d = (3.5/E 1 ) P 80 MHz to 800 MHz Radiated RF disturbances according to IEC V/m 80 MHz to.5 GHz E 1 = 3 V/m d = (7/E 1 ) P 800 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 abovementioned 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 0009 DK 1690 Version /01/018 custo med GmbH [] Spirometry Hardware, custo spiro mobile page 14

15 Recommended protective distances between portable and mobile RF telecommunication devices and custo spiro mobile custo spiro mobile is designed for operation 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. 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 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 0009 DK 1690 Version /01/018 custo med GmbH [] Spirometry Hardware, custo spiro mobile page 15

16 Spirometry.9 EC Declaration of Conformity MHW 0009 DK 1690 Version /01/018 custo med GmbH [] Spirometry Hardware, custo spiro mobile page 16

17 .10 List of product components and accessories Set no. Set name Part no. Qty. Set/product designation custo spiro mobile custo spiro mobile Measuring head for custo spiro mobile Adapter for custo spiro mobile (67 mm) Nose clip custo spiro protect bacterial and viral filter Accessories Part no. Set/product designation Measuring head for custo spiro mobile 11034/Z Adapter for custo spiro mobile (67 mm) 106 custo spiro protect bacterial and viral filter (box of 00 pieces) custo spiro comfort table support 1005 Nose clip 199 Calibration pump 3l MHW 0009 DK 1690 Version /01/018 custo med GmbH [] Spirometry Hardware, custo spiro mobile page 17

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