IP-Set ECG PREWIRED ELECTRODE STRIPS for
Contents
1. Each pre connected harness enables a clean positioning due to preset and adequate wire lengths and saves time The harness is then connected to any type of electrocardiograph or monitoring system by an interface cable This enables to keep the harness positioned on a patient between different hospital services and reconnect it to the different services hardware Monitoring specificity diagnostic coronary intensive care operating room stress control environment X rays and patient size adult pediatric neo natal require different number electrode numbers electrode sizes wiring lengths and material composition radio opacity This leads to a complete family of 16 different pre assembled sets of electrodes as summarized next pages Harness connection to interface cable amp example of interface cable 2 Technical Description 2 1 IP Set Product Set of disposable single use pre gelled ECG electrodes regrouped on a flat cable sole or by pair and located to ease their positioning on the patient Electrode number and positioning design vary according to the monitoring application Pre gelled electrodes are of Ag AgCl thin film on a carbon Eyelet construction with a sensor element area between 10 and 20 mm in diameter and an adhesive part between 20 and 90 mm in diameter Lead wires are regrouped in a flat cable and are made of copper or carbon fiber radio translucent Integral Process has developed a specific set jack plug to con2. STORAGE The storage conditions for the devices are as follows Please note e Ambient temperature 40 to 100 F 5 to 38 C Aras 7 l e A device must not be used for more than one patient g Aine obese Be aire 7 oS Ns 537 e e The device cannot be sterilised 500 to 1060 hPa 14 8 to 31 39 inHg e Expiratory date as shown on the packaging PACKAGING The devices are packaged either singly or in pairs in an aluminised plastic bag sealed foil available in boxes containing either 25 or 60 units depending on their types and or intended uses When they are not in use devices of this kind must be stored in their original packaging in order to prevent any damage which might reduce their service lives performances and or safety levels The device s use by date is shown on its packaging VI GUARANTEE LIABILITY INTEGRAL PROCESS can only guarantee that the device will work properly if it is stored under the conditions described in these instructions if it has not suffered any apparent mechanical damage and if the expiry date for its use is valid INTEGRAL PROCESS guarantees that the device complies with the specifications of the current safety and performance standards applicable to it The class and type of protection BF CF against electric shocks are defined by the type of electromedical device to which the devices are connected Please note f Always read the instruction manual for the particular apparatus before applying th
3. the IP Set ECG electrode strips are Class Il e The positioning of ECG electrodes can only be carried out by a health care provider familiar with proper placement and use The ECG electrodes can only be applied to intact clean skin not over open wounds lesions infected or inflamed areas e After use always remove carefully the ECG electrodes so as not damage the skin of the patient e inthe operating room ensure that all or part of the device is outside of the operating area This is done in order to reduce any risk of burning the patient while the electrosurgical unit is in operation as far as possible N PLEASE NOTE INTEGRAL PROCESS may not be held liable for any incidents which might occur to the patient to the user and to any other persons caused by the presence of dangerous electrical currents from other electromedical devices particularly Electro Surgical Unit or Defibrillator e IP Set cannot be used for more than one patient IP Set cannot be sterilised e 1P Set have to be used with caution in MRI environment e Always read the instruction manual for the particular medical device and for the ECG interface cable before applying the devices l DESCRIPTION FIELD OF APPLICATION DEVICE DESCRIPTION 1 Presentation To the difference to other marketed substantial equivalent ECG electrodes Integral Process electrodes are pre wired and are offered as a full range of combinations covering all main types of application
4. ARDEV125WO0001 A selon directive Nr 93 42 CEE Date d imposition du marquage CE 14 juin 1998 as per EEC directive No 93 42 Date of Imposition of EMI marking 14 June 1998 INSTRUCTION MANUAL IP Set ECG PREWIRED ELECTRODE STRIPS for single patient use Please carefully read the following information Failure to observe the precautions for use may lead to serious medical consequences Important note This insert is designed to provide guidance on the use and handling of the IP SET ECG prewired electrode strips No reference is made to a cardiological technique The manufacturer declines any responsibility for problems resulting from improper use of the product ON used Please read both the instruction manuals for the device and the Please adhere to current WEEE Waste Electrical and Electronic IPO Ype INTEGRAL PROCESS EGO imteriace cable ang ine Equipment disposal legislation in the scandent in question a leaflet or user for the Y medical device Q swe Use Maximum storage and handling temperature For Adults and For Ads and great ohiaren children Doesnotconaiitaiex Br CE marking Complies with directive 93 42 EEC xs Klar iorneonaise applicable with effect from 14 June 1998 Bd EE Keep in a dry place ae Expiratory date mi Not for paediatrics Wane away onion For paediatrics infants and p y young children The classification rules vary from country to country According to USA FDA and Canada CMDCAS regulations
5. DE AHA RA RIGHT ARM WHITE LA LEFT ARM BLACK LL LEFT LEG RED RL RIGHT LEG GREEN 4 intercostal space right edge of the sternum RED 4 intercostal space left edge of the sternum YELLOW on the 5 rib between C2 and C4 GREEN 5 intercostal space left medioclavicular line BLUE between C4 and C6 on the front left axillary line ORANGE on the left mid axillary line at C4 level VIOLET ALLERGICITY The materials used to manufacture INTEGRAL PROCESS devices have been subjected to allergicity tests These tests have not shown the presence of any products which might trigger an intolerable allergic reaction Report NAMSA no 04C_40861_02 04T_51183_01 04C_40861_01 etc For certain patients It is not totally excluded that a skin irritation may happen at the point of contact between the electrode and the skin V MAINTENANCE HYGIENE STORAGE PACKAGING HOW TO HANDLE SPECIAL CONDITIONS e Do not use a device or part of a device if there is any risk to the patient e g damaged insulating material PREVENTIVE MAINTENANCE e You must ensure that the expiry date shown on the protective wrapper is still valid after this date INTEGRAL PROCESS can no longer guarantee that the device will work properly e The conditions for the storage of these devices must be adhered to See chapter II of this instruction manual CORRECTIVE MAINTENANCE e There is no corrective maintenance for this product HYGIENE
6. ds 5 Proceed to record the 6 additional leads Disconnect the plug from the device corresponding to the precordials Plug the 50507 US device s connector into the appropriate ECG interface cable for the taking of the additional ECG Length in mm 300 1050 1700 Ref 50507 US Device for the taking of the additional ECG for example V3R V4R VE V7 V8 V9 Proceed to record the additional ECG signals A Carefully remove the ECG electrodes so as not damage the skin of the patient IV PERFORMANCES RELIABILITY SAFETY COMPATIBILITY MECHANICAL INTEGRITY SYMBOLS ALLERGICITY PERFORMANCES RELIABILITY The devices are inspected both during and at the end of the manufacturing process according to a technical protocol drawn up in line with current standards and regulations on this type of product The test results have been authenticated by a notified Body They have also undergone clinical testing and assessments LNE Gmed technical report no G011847 C2 SAFETY The devices are designed and manufactured to meet current recommendations based on the general and special specifications of the relevant current International European and or National standards International standards IEC 60601 1 1988 A1 1991 amp A2 1995 subclause 56 3 as required per 21CFR898 American standard AAMI ANSI EC 12 2000 amp EC 53 1998 International standard
7. e devices INTEGRAL PROCESS may not be held liable for any incidents which might occur in the event of any failure to adhere to the rules of installation and use mentioned in this instruction manual CAUTION FEDERAL LAWS USA RESTRICT THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN INTEGRAL PROCESS Z A des Boutries 12 rue des Cayennes BP 310 78703 CONFLANS SAINTE HONORINE CEDEX France Tel 33 0 1 39 72 66 66 Fax 33 0 1 39 72 61 61 www inteqral process com E MAIL FOR FRANCE ventes integral process com INTERNATIONAL E MAIL sales integral process com COMM DOCU 100 008 2 March 2013
8. electrode will be laid out on the patient Placing the electrodes gt Remove the electrode s protective sheet Place the electrode on the site corresponding to the location designated by the colour or symbol N B Always start by positioning the device s electrode which is the furthest from the connector Proceed in the same way for each of the chosen device s electrodes to be positioned on the patient ARDEV125WO0001 A INSTRUCTION MANUAL IP Set ECG PREWIRED ELECTRODE STRIPS for single patient use 1200 300 Ae l y Length in mm O O O 35 The electrode furthest away from the connector Chest electrodes for V1 V2 V3 V4 V5 V6 P N 50503 US 1500 P 600 amp Length in mm Limb electrodes for the standard ECG DI DII DIII P N 50500 US P N 50502 US 3 Placing devices conductors Fix the device s conductors in order to avoid any undesirable traction on the electrodes It is a good idea to fasten the device onto the patient using an adhesive plaster Plug the device s connector into the appropriate ECG interface cable for the taking of the standard ECG Plug the device s connector into the appropriate ECG interface cable for the taking of the precordial ECG See also the specific instruction manual for the particular IPC interface cable COMM DOCU 700 038 4 Proceed to record the 12 lea
9. ht occur to the patient to the user and to any other persons caused by the presence of dangerous electrical currents coming from the electromedical device ARDEV125WO0001 A INSTRUCTION MANUAL IP Set ECG PREWIRED ELECTRODE STRIPS for single patient use COMPATIBILITY In order to ensure compatibility between devices use only the specific IPC type ECG INTEGRAL PROCESS cables mentioned in the commercial documentation See catalogue COMM DOCU 001 027 On the company s website www integral process com INTEGRAL PROCESS offers its customers a downloadable document including information on the device s compatibility along with technical details about it MECHANICAL and ELECTRICAL INTEGRITY In order to ensure the mechanical integrity of the devices conductors connectors cable and to reduce the risk of damage during use INTEGRAL PROCESS has used high quality highly reliable materials The devices are designed to withstand repeated defibrillation shocks Adherence to the conditions of storage and use is crucial in order to keep the device s characteristics at an acceptable level The device must not be used after the expiry date shown on its packaging The electrodes are repositionable The maximum application time to the skin of the patient should not exceed 72 hours Over this delay or in case of less adhesitivity or conduction defect the IP Set has to be replaced if needed for the application ELECTRODES COLOUR CODES US COLOUR CO
10. maximum functionality And they can be used on all type of patients adult paediatric or neonates in all disciplines which require the taking of an ECG according to the Physician s decision e g diagnosis medium or long term monitoring stress tests operating rooms Emergency departments Neonates department transfers of patients between different departments radiology angiography and coronarography Suggested Intended Use LIST OF REFERENCE NUMBERS P N AND INTENDED USE SUGGESTED APPLICATION CHART OF IP SET Electrodes sets AHA colour coded leads ee Electrode s Suggested Electrode s Suggested MODEL positioning Awos Intended use positioning ANW ONKS Intended use 4 Leads ECG 7 l 12 Leads Monitoring 1S T Le diagnostic ECG 4 Limb s 6 double IP SET 12 r chest s electrodes 6 chests Leads electrodes STANDARD APPLICATIONS 50507 US 6 additional chest s electrodes Pa IP SET C 50401 US fim e s pS Tooo 3 separate ECG wr cys m Leads P IP SETN3 50600 US ae 50602 US S O ae 4 Leads ECG 12 Leads Monitoring 5 he e diagnostic ECG IP SET M3RT 50603 US 6 chests Leads IP SET 12RT NS 903 Ah Limb s 6 double SZ electrodes HA oop e chest s electrodes X RAYS TRANSLUCENT APPLICATIONS 5 Leads ECG 12 Leads Monitoring a 0 o gt oop diagnostic ECG 3 4 Limb s amp 1 5 5 chests lead ahi Chest
11. nect the harness to the interface cable 2 2 Available Sets INTEGRAL PROCESS offers a full range of IP Set ECG electrode strips in its catalogue commbocuo01 027 which can be viewed and downloaded on the company s website at www integral process com Intended use is mentioned clearly on the different packaging labelling diagnostic monitoring neonates etc 2 3 Packaging Each set harness is packaged in one OPP PE laminated pouch Shipping cartons contain 12 boxes Depending pouch size 10 to 50 are supplied Sets are supplied non sterile For helping users quick colored graphic identification logo are used each ECG set reference is associated to a colored graphic logo for quick identification In case many different IP SET types are used in the same department the colored logo may help to save time and avoid errors IP Set ECG electrode strips are referred to as devices in the subsequent chapters of this instruction manual ARDEV125WO0001 A INSTRUCTION MANUAL IP Set ECG PREWIRED ELECTRODE STRIPS for single patient use II INTENDED USE SUGGESTED INDICATION There are several types of IP Set ECG prewired electrode strips offering different complementary features and designed for taking an ECG on a single patient Whether or not they are coupled they thus allow the ECG signal to be taken from 1 DII to 18 leads They can be used in various different applications always offering safe operation and
12. s ISO 14971 ISO 10993 1 ISO 10993 5 amp ISO 10993 10 Radiolucent tests conducted according to ASTM F640 The devices are part of the applied part to the patient as defined by the IEC 60601 1 International safety and essential performance standard The safety class the type of protection BF CF the degree of protection against electric shocks from the devices are closely linked to those of the electro medical device to which it is connected R Please read the instructions for the electromedical device before applying the ECG cable for IP Set ECG prewired electrode strips aaa devices are sensitive to electromagnetic fields So it is a good idea to remove these sources of radiation to a safe distance from the evices In the operating room ensure that all or part of the device is outside of the operating area This is done in order to reduce any risk of burning the patient while the electrosurgical unit is in operation as far as possible The devices have no accessible metal parts Their use in the surgical operation room requires additional precautions for application by ensuring that the ECG electrodes are outside of the operating area Low frequency leakage currents measured in accordance with the recommendations of the current standards which are applicable to this product are below the authorised values LNE GMED technical report no J021341 C2 PLEASE NOTE INTEGRAL PROCESS may not be held liable for any incidents which mig
13. s electrodes electrodes MONITORING DIAGNOSTIC FIELD OF APPLICATION Each set comes with repositionable pre gelled contact electrodes They are only designed for application to a single patient The innovative design of IP Set strips simplifies the electrodes positioning and avoids connection errors The positioning of ECG electrodes shall be carried out by a health care provider familiar with proper placement and use MN The ECG electrodes shall be applied to intact clean skin not over open wounds lesions infected or inflamed areas The flat connecting cable has a specific connector at the other end which can only be connected to the electromedical device using an IPC type INTEGRAL PROCESS ECG interface cable See catalogue COMM DOCU 001 027 Ill INSTALLATION USE INSTALLATION Please follow these instructions for optimum installation and operation of the devices and look at the electrodes placement shown on the packaging Example of taking the ECG signal with 12 18 leads 1 Choose the appropriate device s for the measurement ECG with 12 leads ref for the whole of the two devices 50502 US Additional set for 18 leads ref 50507 US 2 Place the device s or devices electrodes corresponding to the site in question by following these stages Preparing the patient gt Remove any hair by shaving if necessary First use an appropriate cleaning product ethyl alcohol ether etc to clean the location where the
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