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MONITOR multiparameter(Mindray ePM10) ward+acc.230V 50-60Hz

https://unicat.msf.org/cat/product/96456
STD EEMDMONP23W

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Former Code(s): EEMDMONE23W
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
Z1203020201 - Multi–parameter patient bedside monitors
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
IIb
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
P
The order of this product needs to be justified and is only acceptable under certain conditions.
CT3+
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)
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MONITOR multiparameter (ePM10) for ward

For the patient monitors, MSF moves from 2 levels of GE healthcare monitors, the Dinamap V100 and the B125, to a more layered offer with 3 levels‌ of Mindray monitors, each levels corresponding to specific measured parameters

  • The vital signs monitor VS8 (with spot check and continuous measurements for Non Invasive Blood Pressure (NIBP) and SPO2; not temperature nor ECG)
  • The basic vital signs monitor ePM10 (with continuous measurement of NIBP, SPO2, temperature, ECG; but not spot check)
  • The advanced vital signs monitor ePM12M (with continuous monitoring of NIBP, SPO2, temperature, ECG, CO2, and IBP; but not spot check)

Definition

Basic vital signs monitor designed for continuous measurement of heart rate, respiratory rate, electrocardiogram, pulse oximetry, temperature, and non-invasive blood pressure.

This type of multiparameter monitor is aimed to be used in red zones (resuscitation area) of emergency departments​ (not for spot checking during triage), intensive care units (e.g. basic ICU-level 1 or intermediate ICU-level 2), and during medicalised transport.

This monitor replaces some of the uses of the monitor B125 of GE Healthcare.

Specifications

  • Non Invasive Blood Pressure (oscillometry NIBP)
    • modes: manual, auto, STAT, sequence
    • parameters: systolic, diastolic, mean
    • measuring time: <15 sec typical, max 180 sec adult
    • Systolic Range: 25 mmHg to 290 (adult) or 140 mmHg (new born)
    • Diastolic Range: 10 mmHg to 250 (adult) or 115 mmHg (new born)
    • +/-5 mmHg error and +/- resolution
  • Oxygen Saturation (SpO2)
    • range: 0-100% (from Mindray SPO2)
    • accuracy (@>70%): +/- 2% adult, 3% neonate
    • 1 sec refresh rate
  • Pulse Rate (PR)
    • 20-300 +/- 3 bpm (from Mindray SpO2)
    • 30-300 bpm +/- 3% (from NIBP)
    • 1 sec refresh rate
  • Electrocardiogram (ECG)
    • 5 lead set I, II, III, aVR, aVL, aVF, V
    • input signal range +/- 10mV (p-p)
    • 4 steps sweep speed
    • 6 step gain, plus auto
    • Defib protection up to 5000V (360J) with < 5s recovery time
  • Heart Rate (HR)
    • 15 to 300 bpm Adult; 350 bpm Child; +/- 1% or 1 bpm
    • HR Resolution +/- 1 bpm
  • Respiration Rate (RR)
    • Lead I, II or auto
    • range 0 to 200 rpm +/- 1 < 120 rpm then +/- 2 > 120 rpm
    • RR resolution of 1 rpm
    • 5 steps sweep speed
    • Apnea time: 10s to 40s in 5s increments
  • Temperature
    • 2 channel thermal resistance
    • range: 0 to 50 °C (32 to 152 °F)
    • Accuracy +/- 0.1 °C and resolution 0.1 °C
  • Data History
    • up to 1000 NIBP checks;
    • up to 120 hrs (@ 1 sec interval) in continuous mode
    • up to 1000 events (parameter or technical alarms)
  • Clincal Assistive Application
    • Early Warning Score (mews, news, pews)
    • GCS, pain score, targeted goal views
    • Orthostatic BP measurement
  • Alarms
    • prompting tone
    • 3 different tones/levels for alerts
    • Red/Yellow/Cyan LED levels
    • alarm message displayed
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Quality standards

  • EN IEC 80601-2-49, 2019, edition 1, Medical electrical equipment -- Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
  • EN IEC 80601-2-30, 2019, edition 2, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
  • ISO 80601-2-55, 2018, edition 2, Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
  • IEC 60601-1, 2022, edition 1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Components

EEMDMONE2300 are composed of

  • 1 x EEMDMONA2300 ePM 10 basic main unit with 10.1" touchscreen including
    • 2 USB ports, 2G Data Storage
    • Built-in NIBP, Temp, 3/5 ECG, Mindray SpO2
    • 1 x Li-ion Battery (2600mAh - 2hr runtime)
    • Algorithms: ECG summary, ARR, ST, CAA, GCS, EWS
  • 1 x Software/Manual English language - DJ10-0005-002
  • 1 x EEMDMONS2201 Power cord - EU (European) DJ10-0002-002

The EEMDMONP23- is a Package composed of EEMDMONE2300 and of all the necessary components to start performing NIBP, SPO2, ECG and temperature monitoring (see "Supplied with article" section below)

Technical specifications

  • Hardware
    • 10.1" capacitive color screen (1280x800 pixels)
    • up to 8 waveform channels
    • IPX2 ingress protection
    • 45-85 dB alarm tones
    • drop test 0.75m for all 6 surfaces (ePM10)
    • 1x equipotential grounding terminal
    • class 1 protection: type CF (SpO2, NIBP, Temp)
    • CISPR11 RF: Group 1 Class A
    • 0.5-5V 10mA Nurse Call signal
    • optional thermal printer (25mm/s)
  • Power
    • 100-240V +/-10%, 50-60Hz +/- 3Hz; 2.0A
    • rechargable Li-ion battery 2600mAh (2 hrs) or 5200mAh (4 hrs)
    • DC in connector for ePM10
    • Automatic switch between battery and mains powered mode when recharging or in mains power failure
    • Shutdown delay of at least 20 min after low battery alarm
  • Environmental Requirements
    • 0-40 C operating temperature
    • 15-95% non-condensing humidity
    • 427-805 mmHg (57-107.4 kPa) barometric pressure
  • Communication Interface
    • WiFi IEEE 802.11 a/b/g/n
    • 1x RJ45
    • 2x USB 2.0
    • 1x VGA port
    • 1x multi functions connector
    • optional HL7, eGateway, VistaIsLink data output

Dimensions

size: 271 x 226 x 173 mm

weight: 3.2 kg

Transport Dangerous Goods

  • UN3481 Lithium ion batteries contained in equipment
  • Class: 9
  • Packing Instructions: 967 Section II
  • The label must include the UN code of the battery + an emergency number to contact in case of an incident
  • Limit per package:
    • Pax A/C (Passengers & Cargo Aircraft) = 5 kg
    • CAO (Cargo Aircraft Only) = 5 kg
Image Image

Supplied with the Article

Only EEMDMONP23- package is supplied with

  • 1 x EEMDMONA2202 Rolling Stand (Standard) + commen Quick lock (all models 12" inch screen max and VS) - 045-004267-00

SpO2

  • 2 x EEMDMONA1601 SpO2 Connection cable, 7-pins - 0010-20-42710
  • 1 x EEMDMONA2314 SpO2 SENSOR adu/ped ear-clip reusable 513A
  • 1 x EEMDMONA2315 SpO2 SENSOR neo foot tie reusable 518BLH
  • 2 x EEMDMONA2325 SpO2 SENSOR adu finger-clip reusable 512F
  • 1 x EEMDMONA2326 SpO2 SENSOR child finger-clip reusable 512H

NIBP

  • 2 x EEMDMONA2327 NIBP Tubing, Adu/Child/Infant, with air plug connectors (3m) - 115-012522-00
  • 2 x EEMDMONA2301 CM1300 reusable cuff, neonate 7-13cm with connector - 040-000968-00
  • 2 x EEMDMONA2302 CM1301 resuable cuff, Infant, 10-19 cm, with connector - 040-000973-00
  • 2 x EEMDMONA2303 CM1302 resuable cuff, Infant, 18-26 cm, with connector - 040-000978-00
  • 3 x EEMDMONA2304 CM1303 resuable cuff, Adu, 25-35cm, with connector - 040-000983-00
  • 2 x EEMDMONA2305 CM1304 resuable cuff, Large Adu, 33-47cm, with connector - 040-000988-00
  • 2 x EEMDMONA2306 CM1305 resuable cuff, adult thigh 46-66cm, with connector - 040-000993-00

ECG

  • 1 x EEMDMONA2328ECG TRUNK CABLE 3/5-lead 12pins ESU 0010-30-42723
  • 1 x EEMDDEFA207 ECG WIRE 5-lead wires, adu/ped clip 1-1.4m cable EL6504A - 0010-30-42730

TEMP

  • 1 x EEMDMONA2316 SKIN TEMPERATURE PROBE adult reusable MR403B - 0011-30-37393
  • 1 x EEMDMONA2317 SKIN TEMPERATURE CABLE CHILD/NEO 0011-30-37395
  • 2 x EEMDMONA2318 TEMPERATURE PROBE esophageal/rectal adult reusable MR401B - 0011-30-37392
  • 2 x EEMDMONA2319 TEMPERATURE PROBE esoph/rect child/neo reus.MR402B - 0011-30-37394

To be Ordered Separately

Necessary based on medical activity and patient quantities

  • EEMDMONC2302 SpO2 Sensor adult (>30kg)/neo (<3kg) disposable with adhesive 20/pack 521N
  • EEMDMONC2304 ECG NEONATAL ELECTRODE single use 900E-10-04880
  • EEMDMONC2305 ECG CHILD/NEO ELECTRODE s.u. 040-002833-00
  • EEMDMONC2306 ELECTRODE ADULT s.u. 040-002711-00

Optional

  • EEMDMONA2401 WALL MOUNT BRACKET 045-003427-00
  • EEMDMONA2406 HOOK CABLE MANAGEMENT KIT 045-003814-00
  • EEMDMONA2205 QUICK LOCK ADAPTOR 045-003424-00
  • EEMDMONS2301 BATTERY HI CAP Li rech.10.9V 5200mA 115-065140-00
  • EEMDMONC2323 ACCESSORIES MANAGEMT STRAP 62cm 009-003903-00

SpO2

  • EEMDMONC2303 SpO2 Sensor infant disposable with adhesive 20/pack 521L
  • EEMDMONA2312 SpO2 Sensor adult finger-TIP reusable 512E
  • EEMDMONA2313 SpO2 Sensor child finger-TIP reusable 512G

NIBP

  • EEMDMONC2314 CM1500B single patient cuff neonate 4.3-8cm
  • EEMDMONC2316 CM1500D single patient cuff neonate 7-13cm
  • EEMDMONC2318 CM1501 single patient cuff infant 10-19cm
  • EEMDMONC2319 CM1502 single patient cuff child 18-26cm
  • EEMDMONC2320 CM1503 single patient cuffadult 25-35cm
  • EEMDMONC2321 CM1504 single patient cuff large adult 33-47cm
  • EEMDMONC2322 CM1505 single patient cuff adult thigh 46-66cm

Instructions for use

Device intended for the continual monitoring of patients in general or basic departments

Precautions for Use

Secure the electrical protection of the apparatus with a double conversion UPS (see related articles below).

Maintenance

Maintenance menu has 3 levels (clinical, service, factory) of password protection to adjust settings parameters [IFU Ch 25]

Contact your biomedical advisor to get the passwords if needed.

DAILY

  • Clean your equipment on a regular basis, consulting hospital IPC procedures. Only use slighly damp lint-free cloths‌ with a Surfanios solution. Clean screen, housing, cables but never inside the connectors or metal parts. [IFU Ch 27]
  • Visual inspection
  • Power-on self test

BATTERY [IFU Ch 26]

  • Functionality test on installation or replacement
  • Performance test every 3 months or if runtime is reduced significantly

EVERY 2 YEARS [IFU Ch 28]

  • Electrical safety tests
  • Performance test sensors, outputs and measurements and calibrate or repair as necessary

Storage

Temperature -30 to 70 °C

10 to 95% relative humidity (non condensing)

120 to 805 mmHg (16 to 107.4 kPa)

Waste management

Follow MSF GDPR, IPC and Watsan recommendations for disinfection and recyling of electronic waste

MSF requirements

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