operating manual reusable pulse oximetry sensors - spo2 réutilisable...

Operating manualReusable Pulse Oximetry Sensors

FingerClip, Earclip, Multisite Wrap, Multisite Y, SoftTip® plus (autoclavable), SoftTip®

006-07-GA_SpO2_sensors_reusable-11002237

Technische Änderungen vorbehalten. Subject to technical changes.

03.2015 © 2015 EnviteC-Wismar GmbH

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28 006-07-GA_SpO2_sensors_reusable-1 / 03.2015

Operating Manual - Reusable Pulse Oximetry Sensors

Operating manuel -Reusable Pulse Oximetry SensorsFingerClip, Earclip, Multisite Wrap, Multisite Y, SoftTip® plus (autoclavable), SoftTip®

Indication for useThe reusable SpO2 sensors are indicated for continuous, non-invasive or spot check monitor-ing 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, phy-sicians, 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 con-junction with non-compatible components. The user has to check the functionality relat-ing 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 sensorThe 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 weightPatient 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.

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• 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 interferenceThe following objects / conditions have the potential to interfere with the sensor’s proper func-tioning 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 recom-

mended.

CompatibilityThe 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 (manufac-turers). 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 sensorsSome 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 includ-ed with the sensor.


DangerA correct measurement is not possible when the sensor is connected to an incompat-ible monitor. The measurement result may deviate signifi cantly from the actual mea-surement values.

Possible damageConnecting 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 sensor1. 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. Affi x 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 incor-rectly, 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 Prolystica1, 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.



Automated Cleaning, Disinfection and Sterilisation (SoftTip® plus)Only SoftTip plus sensors are suitable for cleaning in automated instrument processing de-vices (e.g. sterilisation with steam in autoclaves). Only sterilise the sensor at low-temperatures with the Advanced Sterilization Products validated >Sterrad Low Temperature Plasma-Sterili-sation< procedure.

Please observe the instrument processing instructions when doing so.

Further indications regarding the hygiene reconditioning as well as information about the max-imum 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“.

Specifi cationsBecause 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:

70 – 100%: See box label

< 70%: not specifi ed

Pulse rate: 30 – 250 BPM: ±3 BPMWith ChipOx® 20-300 BPM: ±3 BPM For specifi cations, instructions and warnings, refer to the operating manual of the monitor.

IPX information: See box label

Accuracy of valuesA 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 pig-mentation of human skin.

Please refer to the sensor packaging for further information on their accuracy, wavelengths and output power*.



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.



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.

NONSTERILE

LATEX

Non-Sterile Dispose of Responsibly Latex Free

104°F 40°C

41°F 5°C

158°F 70°C

-4°F-20°C

Relative Humidity Operation Temperature Storage Temperature

Year-Month

REF

Manufacturing Date Article Number Manufacturer

Rx ONLY SNPrescription Use Only Serial Number Global Trade Item Number

134 °C273 °F

Autoclaving 1) Thermal Disinfection 1) Automated Cleaning 1)

IPX IPX2 IPX7Protection class against water

and dustProtection against dripping

waterProtected against the effect

of immersion

1) only applies to SoftTip® plus

Symbols and Figures

Symbols and Figures


Reusable SpO2 Sensor FingerClip

> 20 kg

Adults / Pediatrics

Figures

Fig. 1

FingerClip

Fig. 2

Symbols and Figures


Fig. 3

Reusable Pulse Oximetry Sensor EarClip

Reusable Pulse Oximetry Sensor MultiSite Wrap

Reusable Pulse Oximetry Sensor MultiSite Y

> 30 kg

Adults / Pediatrics

Adults

Infants

Neonates

> 3 kg≤ 20 kg

≤ 3 kg

> 10 kg

Fig. 4

EarClip

Symbols and Figures

MultiSite Wrap

Outside

Inside

06-00-1463R T T R

R T T R

R T T R

T

R

Fig. 5

T

TT

R


Symbols and Figures

MultiSite YTransmitter

Receiver

Inside

Outside


Fig. 6

Symbols and Figures

Fig. 7

SoftTip®, SoftTip® plus

Ø 7.5 mm to 12.5 mm ► RS (small) model

Ø 10 mm to 19 mm ► RM (medium) model

Ø 12.5 mm to 25.5 mm ► R (large) model


Symbols and Figures

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Operating Manual Reusable Pulse Oximetry Sensors


Notes

99

Operating Manual Reusable Pulse Oximetry Sensors


EnviteC-Wismar GmbH a Honeywell Company

Alter Holzhafen 1823966 WismarGermany

Tel.: 49 - (0) 3841 360-200Fax.: 49 - (0) 3841 360-222Internet: www.envitec.com

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