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Dräger Infinity M300 series Supplemental Manual

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Supplement
Infinity M300 and M300+ Series
WARNING
For a full understanding of the
performance characteristics of this
device, the user should carefully read
this supplement and the related
instructions for use before use of the
device.
Infinity M300 and M300+ Series
Software VG2.4

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Table of Contents

   Related Manuals for Dräger Infinity M300 series

   Summary of Contents for Dräger Infinity M300 series

  • Page 1 Supplement Infinity M300 and M300+ Series Infinity M300 and M300+ Series WARNING For a full understanding of the Software VG2.4 performance characteristics of this device, the user should carefully read this supplement and the related instructions for use before use of the device.
  • Page 2 Trademarks Trademark Trademark owner ® Actichlor Ecolab ® BruTab 6S Brulin ® Dispatch Clorox ® Buraton Schülke & Mayr ® Mikrozid ® Perform ® acryl-des ® Descogen Antiseptica ® Dismozon Bode Chemie ® Klorsept Medentech ® Infinity Dräger ® Oxycide Ecolab USA ®...
  • Page 3: Table Of Contents

    Contents Supplement Infinity M300 and M300+ Series VG2.4 ........Infinity M300/M300+ Indications for use/Intended use .
  • Page 4 This page has been left blank intentionally. Supplement – Infinity M300 and M300+ Series – VG2.4...
  • Page 5: Supplement Infinity M300 And M300+ Series Vg2.4

    Supplement Infinity M300 and M300+ Series VG2.4 Supplement Infinity M300 and M300+ Series VG2.4 This supplement contains the VG2.4 instructions for use for the Infinity M300 and the new Infinity M300+, that features a swappable battery. The IFU that ships with this supplement is the Infinity CentralStation Wide SW VG 1.n and Infinity M300. M300/M300+ Device description The Infinity M300/M300+ is a patient-worn transceiver that includes a color display, local alarm alerts, wireless communication technology and is powered by a rechargeable Lithium-Ion battery.
  • Page 6: Infinity M300/m300+ Indications For Use/intended Use

    Infinity M300/M300+ Indications for use/Intended use When an Infinity M300+ swappable battery is exchanged it can be charged in the M300+ battery charger to be made ready for later use. NOTE TruST 6-wire calculated 12-lead ECG monitoring is optional. Infinity M300/M300+ Indications for use/Intended use The Infinity M300/M300+ is intended for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network.
  • Page 7 Infinity M300/M300+ Indications for use/Intended use WARNING Inaccurate SpO2 meansurements may result under the following conditions: – Elevated levels of methemoglobin – Elevated levels of total bilirubin – Excessive patient motion – Severe anemia – Low arterial perfusion WARNING Risk of electric shock and device malfunction. Penetrating liquid may cause the following: –...
  • Page 8: Environment Of Use

    Infinity M300/M300+ Indications for use/Intended use Environment of Use The device is intended to be used in an environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
  • Page 9: Device Symbols

    Infinity M300/M300+ Indications for use/Intended use Device symbols The following table lists the new hardware device symbols displayed on various Dräger hardware. Symbol Description Do not re-use, single patient use Do not re-use Not made with natural rubber latex Not made with natural rubber latex Not made with natural rubber latex Refer to the IFU, Infinity CentralStation Wide SW VG 1.n and Infinity M300, that ships with this supplement...
  • Page 10: Infinity M300/m300+ Features For Vg2.4

    Infinity M300/M300+ Features for VG2.4 Infinity M300/M300+ Features for VG2.4 This section contains the Infinity M300/M300+ features for the VG2.4 release. For specific information about the new M300+, refer to "Infinity M300+" on page 18. QRS Threshold Depending on the software versions running on the ICS and the M300/M300+ devices, the procedure you follow to set the QRS threshold on the M300/M300+ will differ: ...
  • Page 11 Infinity M300/M300+ Features for VG2.4 To set the QRS Threshold using earlier ICS and M300 versions For ICS 2.1 or earlier, or M300 VG2.3 or earlier, from the Main ICS screen: 1 Click System setup on the ICS. 2 Click Layouts. 3 Click the dropdown arrow of the appropriate Gain/Scale Channel.
  • Page 12: M300/m300+ Arrhythmia Processing

    Infinity M300/M300+ Features for VG2.4 M300/M300+ Arrhythmia processing Arrhythmias are identified using an internal detection process. This process does the following: – Filters out ECG signal artifacts – Detects the beat pattern – Classifies the beat pattern – Detects the rhythm When arrhythmia analysis is enabled, multiple alarm conditions may occur simultaneously.
  • Page 13: Ecg Signal Processing And Display

    Infinity M300/M300+ Features for VG2.4 ECG signal processing and display The M300/M300+ calculates heart rates within a range of 15 beats to 300 beats per minute, using the R- R intervals of the last 10 seconds. This calculation excludes the two longest and two shortest R-R intervals.
  • Page 14: Ecg Precautions

    Infinity M300/M300+ Features for VG2.4 To maintain a clear signal, change electrodes every 24 to 48 hours or more often when the following occurs: – ECG signal degradation – Excessive patient perspiration – Skin irritation Consider the following when selecting electrode sites: –...
  • Page 15: Ics Telemetry Defaults Screen

    Infinity M300/M300+ Features for VG2.4 ICS Telemetry defaults screen To set the Adult QRS threshold or Pediatric QRS threshold, navigate to the Telemetry defaults screen and select the Layout/Parameters tab, then the Layout tab. Reduced Main screen showing vital signs in real time Main menu bar Telemetry Layout Tab page.
  • Page 16: M300 Demographic Screens

    Infinity M300/M300+ Features for VG2.4 M300 Demographic screens The Infinity M300 two Demographic screens display patient demographic information. All patient demo- graphic information is received from the ICS. Use the Up/Down arrows to jump from screen to screen. Screen 1 Name Bed label Care unit...
  • Page 17: Alarm Settings

    Infinity M300/M300+ Features for VG2.4 Alarm settings While the battery is attached to the M300+, alarm settings and current patient data remain intact for approximately 80 hours after the unit powers down due to a depleted battery. Low battery alarm When the battery power level has reached approximately 30 minutes of remaining charge, a Low battery message is reported visually and acoustically at both the ICS and M300/M300+ to indicate that the battery is low.
  • Page 18: Infinity M300

    Infinity M300+ Infinity M300+ This section contains information about the Infinity M300+ for the VG2.4 release. M300+ front of the device The following figure shows the M300+ front of the device. NOTE Figures of products and screen content in this document may differ from the actual products depending on configuration and design.
  • Page 19: M300+ Swappable Battery

    Infinity M300+ M300+ swappable battery The new Infinity M300+ operates with a swappable, externally rechargeable battery with the following specifications:  Battery recharging time of approximately 3.5 hours  Battery swaps retain clinical data and current alarm settings for approximately two minutes ...
  • Page 20 Infinity M300+ WARNING Risk if the swappable battery contacts are wet. If the battery is detached or removed for service and the electrical contacts are moistened with disinfectant, immediately reattaching or reinstalling the battery while the contacts are still wet could lead to corrosion and contact failure.
  • Page 21 Infinity M300+ Preventive Maintenance The following table shows the preventive maintenance interval for the M300+ swappable battery: Component Interval Measure Personnel Responsible M300+ swappable Every 12 months Replace swappable Users (Medical or Technical battery battery Personnel) Caring for the M300+ lithium-ion swappable battery The following table provides care instructions for the M300+ swappable battery.
  • Page 22 Infinity M300+ To remove the swappable battery from the M300+ 1 Press the two buttons on each side of the swappable battery. 2 Pull down to remove the battery. Press buttons Pull down to remove the battery Supplement – Infinity M300 and M300+ Series – VG2.4...
  • Page 23 Infinity M300+ To check the charge status on the swappable battery When you press the TEST button on the M300+ swappable battery, the battery LEDs light to indicate the battery charge status . Each lit LED indicates a charge percentage, as described below. Charge Indicator Lights Connector Contacts 1 2 3 4...
  • Page 24 Infinity M300+ To insert the swappable battery into the M300+ 1 Press the buttons on the swappable battery. 2 Align and insert the battery into place. NOTE Make sure the swappable battery correctly aligns with the M300+ before securing into place. Press buttons Align and insert the battery into place CAUTION...
  • Page 25: M300+ Battery Charging Station For Swappable Batteries

    Infinity M300+ M300+ battery charging station for swappable batteries The wall-mountable or counter top M300+ battery charging station recharges up to 10 M300+ batteries at a time. Contact your service representative for the wall mounting installation instructions. Approximate charging time is 10 batteries within 4 hours. The charging station provides auto shut off to prevent overcharging, and indicates charging status through illuminated LEDs.
  • Page 26 Infinity M300+ Inserting the swappable battery into the charger 1 After removing the swappable battery from the M300+, insert it into the charging station. 2 Press the battery into place. Removing the swappable battery from the charger 1 Press the two tabs on each side of the swappable battery. 2 Pull the battery up to remove.
  • Page 27: Discharging A Patient

    Infinity M300+ Discharging a Patient CAUTION Failure to discharge previous patient information can result in the mixing of patient archive data at ICS when admitting a new patient using the ICS or the M300/M300+. Patient discharge occurs from the ICS as well as from the M300+. To discharge a patient from the M300+ screen, do the following: 1 On the M300+ keypad, press the Staff alert setting key and the Alarm pause setting...
  • Page 28: Technical Specifications

    Infinity M300+ Technical specifications Infinity M300+ Infinity M300+ specifications Physical specifications Size, H x W x D with battery 157.5 mm x 81.1 mm x 30.6 mm (6.2 in x 3.19 in x 1.2 in) attached Weight 310 g +/- 5g (10.93 oz) Cooling Convection Connections...
  • Page 29 Infinity M300+ Infinity M300+ specifications User interface Controls Six function keys: Alarm pause, view screen, staff alert, record/mark event, up/down scroll Display Size/viewing area 5.5 cm (2.17 in) diagonal LCD Resolution 220 x 176 pixels Communications Wireless Network IEEE 802.11 a/b/g/n wireless Ethernet standards (2.4 – 5GHz) Radio power output 30 mW (2.4 GHz) / 25 mW (5 GHz) Available leads...
  • Page 30 Infinity M300+ Infinity M300+ specifications Pacer detection Leads I and (II or lll) Amplitude ±2 to ±700 mV Width (dp) 0.1 to 2.0 ms ST segment analysis Leads analyzed 3-wire lead set: I, II, or III 5-wire lead set: I, II, III, aVL, aVR, aVF, V 6-wire lead set: I, II, III, aVL, aVR, aVF, V, V+ 6-wire lead set with Infinity TruST: I, II, III, aVL, aVR, aVF, dV1, V2, dV3, dV4, V5, dV6...
  • Page 31 Infinity M300+ Infinity M300+ specifications Accuracy SpO2: 0 to 69 % not specified 70 to 100 % sensor-specific as follows: Masimo LNCS Sensors 1, 2, 3, 4 SpO2 accuracy LNCS DCI, LNCS DCIP, LNCS Adtx, LNCS Pdtx Not specified Pulse rate accuracy: ±3 bpm or ±3 %, whichever is greater Low perfusion accuracy, SpO2:...
  • Page 32 Infinity M300+ Infinity M300+ specifications NOTE Since SpO2 measurements are statistically distributed, only about two-thirds of those measure- ments can be expected to fall within ±1 A of the value measured by a CO-oximeter. These accuracies have been validated using blood samples obtained from healthy adult volunteers during induced hypoxia studies in the range of 70 to 100% SpO2 against a laboratory CO-oximeter and ECG monitor.
  • Page 33 Infinity M300+ Infinity M300+ battery charging station Infinity M300+ battery charging station specifications Physical specifications Size, H x W x D 101.6 x 508 x 114.3 mm (4 x 20 x 4.5 in) Weight, with 0 batteries 1.46 Kg (3.25 lb) Weight, with 10 batteries 2.46 Kg (5.4 lb) Cooling...
  • Page 34: M300/m300+ Performance Data

    Infinity M300+ M300/M300+ Performance data The following disclosures related to algorithm performance using certain waveforms are added or updated to the monitoring specifications: M300/M300+ ECG/Arrhythmia/ST Supplemental information Time to alarm for Ventricular tachycardia 1mVpp, 206 bpm tachycardia Gain 0.5, range 3.0 to 3.5 seconds, average 3.3 seconds Gain 1.0, range 2.9 to 3.3 seconds, average 3.2 seconds Gain 2.0, range 2.8 to 3.5 seconds, average 3.0 seconds Ventricular tachycardia 2 mVpp, 195 bpm...
  • Page 35: M300/m300+ Accessories Overview

    M300/M300+ accessories overview M300/M300+ accessories overview M300+ System Components The following parts are related components of the M300+. Contact your Dräger representative for additional information. M300+ Part Part Number SHIP UNIT M300+ MS33648 E/M ASY M300+ BATTERY MS33308 SHP OEM INF M300+ BATTERY CHGR MS33198 SHP EXC M300+ MS33659...
  • Page 36 M300/M300+ accessories overview LNCS Reusable SpO Sensors Global Part USA Part Japanese Description Number Number Part Number MP00796 MP03019 MP03097 Masimo SpO -Sensor LNCS DC-I MP00795 MP03020 MP03098 Masimo SpO -Sensor LNCS DC-IP MP00788 MP03021 MP03099 Masimo Sen LNCS-TC-I Ear MP00799 MP03022 MP03101...
  • Page 37 M300/M300+ accessories overview M-LNCS Reusable SpO Sensors Global Part USA Part Japanese Part Description Number Number Number MP02981 MP03080 MP03182 Masimo M-LNCS DCI Adult MP02982 MP03081 MP03183 Masimo M-LNCS DCIP Pedi MP02983 MP03082 MP03184 Masimo M-LNCS TC-I Ear MP02985 MP03083 MP03185 Masimo M-LNCS TF-I Adult MP02984...
  • Page 38: Electromagnetic Compatibility (emc)

    Electromagnetic compatibility (EMC) Electromagnetic compatibility (EMC) Medical electrical equipment is subject to special precautionary measures concerning electromagnetic compatibility. During installation and before initial operation, follow the information in section: "EMC declaration for M300+" (page 39). This device can be affected by other electrical devices. WARNING Risk due to electrostatic discharge Malfunctions that endanger the patient may occur if no protective measures against electrostatic...
  • Page 39: Emc Declaration For M300

    Electromagnetic compatibility (EMC) EMC declaration for M300+ General information This device was tested for electromagnetic compatibility using accessories from the list of accessories. Other accessories may only be used if they do not compromise the electromagnetic compatibility. The use of non-compliant accessories may result in increased electromagnetic emissions or decreased electromagnetic immunity of the device.
  • Page 40: Additional Information

    Additional information Recommended separation distances from wireless communication devices To ensure that the functional integrity of this device is maintained, there must be a separation distance of at least 1.0 m (3.3 ft) between this device and wireless communication devices. Additional information ECG, arrhythmia, and ST segment monitoring with M300/M300+ The ST algorithm has been tested for accuracy of the ST segment data.
  • Page 41: Known Issues

    Additional information M300 offline recordings While the M300 is offline or the R50N recorder is not available, the last five recordings (automatic or manual) are stored on the M300. When the connection is restored, those recordings are sent to the R50N recorder.
  • Page 42: Reprocessing Of Device-specific Components

    Reprocessing of device-specific components Reprocessing of device-specific components This section provides information for the reprocessing of M300 and M300+ device-specific components and accessories. Keep this supplement with the instructions for use. Safety Information WARNING Risk due to inappropriately reprocessed products Reusable products must be reprocessed, otherwise there is an increased risk of infection.
  • Page 43: Reprocessing List

    Reprocessing of device-specific components Reprocessing list The M300 and M300+ and all components and accessories are classified as non-critical. Components Surface Manual Machine Steam Special disinfection cleaning cleaning with sterilization reprocessing with cleaning followed by thermal measures disinfection by disinfection immersion M300 and M300+ Detachable battery...
  • Page 44 Reprocessing of device-specific components Class of active ingredient Surface disinfectant Manufacturer Quaternary ammonium com- Mikrozid sensitive liquid Schülke & Mayr pounds Mikrozid sensitive wipes Mikrozid alcohol free liquid Mikrozid alcohol free wipes acryl-des Aldehydes Buraton 10 F Schülke & Mayr 1) Virucidal against enveloped viruses Dräger recommends using a surface disinfectant from the list above.
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  • Page 46 This Supplement only applies to Infinity M300 and M300+ Series VG2.4 with the Serial No.: If no Serial No. has been filled in by Dräger, these Instructions for Use are provided for general information only and are not intended for use with any specific machine or unit.

This manual is also suitable for:

Infinity m300+ series

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