Operating manual Reusable Pulse Oximetry Sensors FingerClip, Earclip, Multisite Wrap, Multisite Y, SoftTip plus (autoclavable), SoftTip 006-07-GA_SpO2_sensors_reusable-1 1002237 DEU GBR DNK GRC ESP HUN FRA ITA FIN JPN Technische Änderungen vorbehalten. Subject to technical changes. NOR NLD PRT SWE POL 03.2015 2015 EnviteC-Wismar GmbH RUS TUR ARE
Operating Manual - Reusable Pulse Oximetry Sensors GBR Operating manuel - Reusable Pulse Oximetry Sensors FingerClip, Earclip, Multisite Wrap, Multisite Y, SoftTip plus (autoclavable), SoftTip Indication for use The reusable SpO2 sensors are indicated for continuous, non-invasive or spot check monitoring of functional oxygen saturation of arterial haemoglobin (SpO2) and the pulse rate of patients in hospitals, hospital-type facilities and home health care. The sensors are suitable for use only by appropriately trained clinicians such as nurses, physicians, and EMS personnel for the treatment of patients in and out of a hospital, as well as during transport. The SpO2 sensor must only be used under the conditions specifi ed in the system s technical documentation and only in combination with recommended and approved monitors or oximetry modules. The sensor might not function properly when used in conjunction with non-compatible components. The user has to check the functionality relating the sensor and monitor before application. Please refer to the monitor s or oximetry module s operating manual for additional instructions and safety information. Selection and suitability of the sensor The sensor must be individually selected for each patient group and in consideration of the body weight limits or of the thickness of the fi nger/toe diameter of fi rst section. The method of application is specifi ed in the attached fi gures. Patient weight Patient weight see fi gures. Safety information In order to ensure the correct and safe operation of the product, it must be carefully and properly transported, stored and operated (see instructions on the packaging). Do not use sensors if damaged. Check sensor and application at least every 4 hours for proper functioning and change the location of the sensor after 4 hours. 28 006-07-GA_SpO2_sensors_reusable-1 / 03.2015
Operating Manual - Reusable Pulse Oximetry Sensors Regarding the special anatomical conditions of the ear, it could be necessary to change the EarClip all 2 to 3 hours. Check position and patient skin for integrity (danger of decubitus, circulatory disorder, skin irritation), and immediately reposition, if necessary. During the use of a long sensor cable or connection cable exists the risk of a strangulation. The materials used for manufacturing the sensor do not contain any natural rubber latex protein. The materials that come into contact with the patient have undergone extensive biocompatibility testing. Further information is available on request. Sources of interference The following objects / conditions have the potential to interfere with the sensor s proper functioning and to cause it to incorrectly measure SpO2: Strong sources of electromagnetic interference, e.g. electrical surgical instruments Strong ambient light and direct light, including infrared and UV light (if required, cover sensor) Intravascular dyes, nail varnish and artifi cial fi ngernails Strong movements (where relevant, consider coiling the sensor cable into a loop to take the strain off the cable and fasten to patient/subject using an adhesive tape) Use of the sensor in X-ray areas or in combination with MRI/MRT devices is not recommended. Compatibility The sensors were validated for proper function with appropriate monitors and for the intended application. Various EnviteC sensors are available for the different types of monitors (manufacturers). The respective monitor compatibility is indicated individually on the packaging of each sensor. The sensor may only be used in in conjunction with a compatible monitor (see: warning note indication for use ). Please refer to the current Cross Reference List on our website for further information on the compability of the sensor. Multicompatible sensors Some EnviteC pulse oximetry sensors are available as multicompatible sensors for connection to different monitors via special adapter cables. These multicompatible sensors are clearly identifi ed on the product packaging and also by the additional adapter cable description included with the sensor. 006-07-GA_SpO2_sensors_reusable-1 / 03.2015 29
Operating Manual - Reusable Pulse Oximetry Sensors Danger A correct measurement is not possible when the sensor is connected to an incompatible monitor. The measurement result may deviate signifi cantly from the actual measurement values. Possible damage Connecting incompatible system components can result in damage to the sensor and/ or monitor. Damage possible from cable breakage! Avoid mechanical stresses (pulling, stretching, twisting) on the sensor cable. During the removal of the sensor from the monitoring connection, don t pull at the cable, please. Using the sensor 1. Choosing a sensor see fi gure. 2. Position the sensor in a suitable location, such as on the index fi nger or on the thumb, big toe or little fi nger. 3. Affix the sensor as shown in the fi gure. The fi nger of the patient must be inserted up to the end of the sensor. Run the cable along the fi nger and parallel to the arm. If necessary, use tape to hold it in place. 4. Connect the sensor cable to the patient cable or monitor, and check the functioning according to the monitor manual. The sensor s reading will only be accurate if it is correctly positioned. If attached incorrectly, the sensor s light signal will not be aimed straight at the tissue, which will affect the SpO2 reading. Misapplication of a pulse oximetry probe with excessive pressure for prolonged periods can induce pressure injury. Cleaning and disinfection Disconnect the sensor from the monitor before cleaning or disinfecting. The sensor must be carefully cleaned and disinfected after every use and before use with a different patient. The sensor can be reused on the same patient for the patient s entire stay. Clean all of the sensor s surfaces (inside and outside) with a disposable cloth and cleaning agent (recommendation: cleaning with Prolystica 1, Steris Coperation). Don t dip the sensor in liquids or cleaning agents. Disinfect the sensor by wiping the sensor body and contact surfaces with a 70% isopropyl alcohol solution. Follow the manufacturer s instructions for use. 30 006-07-GA_SpO2_sensors_reusable-1 / 03.2015
Operating Manual - Reusable Pulse Oximetry Sensors Automated Cleaning, Disinfection and Sterilisation (SoftTip plus) Only SoftTip plus sensors are suitable for cleaning in automated instrument processing devices (e.g. sterilisation with steam in autoclaves). Only sterilise the sensor at low-temperatures with the Advanced Sterilization Products validated >Sterrad Low Temperature Plasma-Sterilisation< procedure. Please observe the instrument processing instructions when doing so. Further indications regarding the hygiene reconditioning as well as information about the maximum number of reconditioning related to the life time of the product group are available on the EnviteC homepage Sterilizing reusable SpO2 sensors - Cleaning an d disinfecting SpO2 sensors. Specifications Because pulse oximeter measurements are statistically distributed, only about two-thirds of measurements can be expected to fall within ± Arms of the value measured by a CO-oximeter as reference method (see table). To determinate the BMP accuracy an original sensor and original monitor was used. SpO2 accuracy: Pulse rate: IPX information: 70 100%: See box label < 70%: not specifi ed 30 250 BPM: ±3 BPM With ChipOx 20-300 BPM: ±3 BPM For specifi cations, instructions and warnings, refer to the operating manual of the monitor. See box label Accuracy of values A functional tester cannot be used to assess the accuracy of a pulse oximeter probe or a pulse oximeter monitor. Recommended for testing and evaluation of SpO2 sensors is the use of a special fi nger simulator (e.g. Index 2, Fluke Biomedical). The clinical studies include a patient population with healthy, adult patient of either gender, different ages as well as different pigmentation of human skin. Please refer to the sensor packaging for further information on their accuracy, wavelengths and output power*. 006-07-GA_SpO2_sensors_reusable-1 / 03.2015 31
Operating Manual - Reusable Pulse Oximetry Sensors The duration of the guarantee is related to the expected life time of the products in case of appropriate use and storage. Earclip, Multisite Wrap, Multisite Y 9 months (max.) FingerClip 15 months (max.) SoftTip (R/RM/RS) 24 months (max.) SoftTip plus (R/RM/RS) 24 months (max.) or 100 reconditioning cycles. * This information is especially useful for clinicians. This product satisfi es the requirements of Directive 93/42/EEC. 1 Prolystica is a registered trademark of Steris Corporation. When the sensor is disposed of, the regulations regarding electronic waste must be heeded. Do not dispose of the sensor in domestic waste! Defective sensors can be returned to any authorised dealer. All sensor packaging may be disposed of as normal household waste. Please note that it is possible and sometimes required to separate the materials for recycling. 32 006-07-GA_SpO2_sensors_reusable-1 / 03.2015
Symbols and Figures Symbols and Figures Symbols Follow the instructions given in the operating manual. Danger of death, serious injury or considerable material damage if the relevant safety measures are not observed. Important information about the product or a specifi c part of the manual which should be read with particular attention. NON STERILE LATEX Non-Sterile Dispose of Responsibly Latex Free 104 F 40 C 158 F 70 C 41 F 5 C -4 F -20 C Relative Humidity Operation Temperature Storage Temperature Year-Month REF Manufacturing Date Article Number Manufacturer Rx ONLY SN Prescription Use Only Serial Number Global Trade Item Number 134 C 273 F Autoclaving 1) Thermal Disinfection 1) Automated Cleaning 1) IPX IPX2 IPX7 Protection class against water and dust 1) only applies to SoftTip plus Protection against dripping water Protected against the effect of immersion 92 006-07-GA_SpO2_sensors_reusable-1 / 03.2015
Symbols and Figures Figures Reusable SpO 2 Sensor FingerClip Adults / Pediatrics > 20 kg Fig. 1 FingerClip Fig. 2 006-07-GA_SpO2_sensors_reusable-1 / 03.2015 93
Symbols and Figures Reusable Pulse Oximetry Sensor EarClip Adults Reusable Pulse Oximetry Sensor MultiSite Wrap Adults / Pediatrics Reusable Pulse Oximetry Sensor MultiSite Y > 10 kg Infants > 30 kg Neonates > 3 kg 20 kg 3 kg Fig. 3 EarClip Fig. 4 94 006-07-GA_SpO2_sensors_reusable-1 / 03.2015
R T T R Symbols and Figures MultiSite Wrap Outside R T T R 06-00-1463 R T T R Inside T R T T T R Fig. 5 006-07-GA_SpO2_sensors_reusable-1 / 03.2015 95
Symbols and Figures MultiSite Y Transmitter Outside Receiver Inside Fig. 6 96 006-07-GA_SpO2_sensors_reusable-1 / 03.2015
Symbols and Figures SoftTip, SoftTip plus Ø 7.5 mm to 12.5 mm Ø 10 mm to 19 mm RS (small) model RM (medium) model Ø 12.5 mm to 25.5 mm R (large) model Fig. 7 006-07-GA_SpO2_sensors_reusable-1 / 03.2015 97
Operating Manual Reusable Pulse Oximetry Sensors Notes 98 006-07-GA_SpO2_sensors_reusable-1 / 03.2015
Operating Manual Reusable Pulse Oximetry Sensors 006-07-GA_SpO2_sensors_reusable-1 / 03.2015 99
EnviteC-Wismar GmbH a Honeywell Company Alter Holzhafen 18 23966 Wismar Germany Tel.: 49 - (0) 3841 360-200 Fax.: 49 - (0) 3841 360-222 Internet: www.envitec.com