0% found this document useful (0 votes)
338 views12 pages

Penlon SP M5 Patient Monitor Technical Specifications: Physical Specification

Documentos

Uploaded by

Julian García
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
338 views12 pages

Penlon SP M5 Patient Monitor Technical Specifications: Physical Specification

Documentos

Uploaded by

Julian García
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 12

Penlon SP M5 Patient Monitor Technical Specifications

PAT I E N T M O N I T O R I N G S O LU T I O N S

Flexible solutions to suit Multi-parameter module


changing clinical situations (MPM)
Five on-board slots and Integrated carry handle
optional module rack with
High visibility, prioritised
eight additional slots
alarms
Up to eight waveforms
Intelligent, quiet cooling
Easy to upgrade system
12.1” colour display with Configurable QuickKeys for
optional touch screen fast access to functions

Physical Specification

Weight <6.6 kg (Standard configuration excluding modules, recorder, batteries and


accessories)

Size (H × W × D) 297 × 336 × 186 mm


Display Screen 12.1” (800 x 600 pixels) Medical-grade colour TFT LCD
Display Traces Up to 8 waveforms

External Display 1 × display through DVI-D connector


2 × displays through RDD

ECG
Meets the standards of IEC 60601-2-27 and IEC 60601-2-25
Lead Set 3-lead: I, II, III
5-lead: I, II, III, aVR, aVL, aVF, V
12-lead: I, II, III, aVR, aVL, aVF, V1 to V6
Automatic 3/5/12 - lead recognition
Input Signal Range ±8 mV (p-p)
Electrode Offset Potential Tolerance ±500 mV
Gain × 0.125, × 0.25, × 0.5, × 1, × 2, × 4, auto
Sweep Speed 6.25 mm/s, 12.5 mm/s, 25 mm/s, 50 mm/s
Waveform format Standard, Cabrera
Bandwidth Diagnostic Mode: 0.05 to 150 Hz
Monitor Mode: 0.5 to 40 Hz
Surgical Mode: 1 to 20 Hz
ST Mode: 0.05 to 40 Hz
Penlon SP M5 Patient Monitor Technical Specifications
PAT I E N T M O N I T O R I N G S O LU T I O N S

CMMR Diagnostic: > 90 dB


Monitor, Surgical, ST Modes: > 150 dB
Pace Detection Amplitude: ±2 mV to ± 700 mV
Width: 0.1 to 2 ms
Rise Time: 10 to 100 µs (without overshoot)
Defib. Protection Withstand 5000 V (360 J) defibrillation
Defib. Recovery Time ≤5s
ESU Recovery Time ≤ 10 s
Provides Glasgow resting 12-lead ECG algorithm

Heart Rate
HR Range Adult: 15 to 300 bpm
Paediatric/Neonate: 15 to 350 bpm
HR Accuracy ± 1 bpm or ± 1%, whichever is greater
HR Resolution 1 bpm

Arrhythmia Analysis
Intended Use Adult, Paediatric

Multi-lead 24 classifications (Asystole, VFib/VTac, Vtac, Vent. Brady, Extreme Tachy,


Extreme Brady, Vrhythm, PVCs/min, Couplet, Bigeminy, Trigeminy, R on T,
Run PVCs, PVC, Tachy, Brady, Missed Beats, PNP, PNC, Multif. PVC,
Nonsus. Vtac, Pause, Irr. Rhythm., Afib.

ST Segment Analysis
Intended Use Adult and paediatric
ST Range -2.0 to +2.0 mV
ST Accuracy ±0.02 mV or ±10%, whichever is greater (-0.8 to +0.8 mV)
ST Resolution 0.01 mV

QT Analysis
Intended Use Adult, paediatric and neonate
Parameters QT, QTc, ∆QTc
QTc formula Bazett, Fridericia, Framingham or Hodges
QT/QTc Range 200 to 800 ms
QT Accuracy ±30 ms
QT Resolution 4 ms
QTc Resolution 1 ms

2 Penlon SP M5 Patient Monitor


Penlon SP M5 Patient Monitor Technical Specifications
PAT I E N T M O N I T O R I N G S O LU T I O N S

QT-HR Range Adult: 15 to 150 bpm


Paediatric/Neonate: 15 to 180 bpm

Respiration
Lead I or II, auto
RR Range 0 to 200 rpm
RR Accuracy ± 1 rpm (0 to 120 rpm), ± 2 rpm (121 to 200 rpm)
RR Resolution 1 rpm
Apnea Time 10, 15, 20, 25, 30, 35, 40 seconds
Sweep Speed 3, 6.25, 12.5, 25, 50 mm/second

SpO2
Meets the requirements of ISO 80601-2-61
SpO2 Module Standard SpO2, Nellcor SpO2
SpO2 Range 0 to 100%
SpO2 Accuracy Adult/Paediatric: ±2% (70 to 100%)
Neonate: ±3% (70 to 100%)
Perfusion Indicator (PI) Yes, for Standard SpO2
Pitch Tone Yes
Dual-SpO2 Yes, SpO2, SpO2b, ∆SpO2

PR
PR Range 20 to 300 bpm (SpO2)
25 to 350 bpm (IBP)
30 300 bpm (NIBP)
PR Accuracy ±3 bpm (20 to 300 bpm, Standard SpO2)
±3 bpm (20 to 250 bpm, Nellcor SpO2)
±1 bpm or ±1%, whichever is greater (IBP)
±3 bpm or ±3%, whichever is greater (NIBP)
Refreshing Rate 1s

Temperature
Meets the requirements of ISO 80601-2-56
Technique Thermal resistance
Channels Up to 4 channels
Temp Range 0 to 50°C (32 to 122°F)

Penlon SP M5 Patient Monitor 3


Penlon SP M5 Patient Monitor Technical Specifications
PAT I E N T M O N I T O R I N G S O LU T I O N S

Temp Accuracy ±0.1°C or ±0.2°F (without probe)


Temp Resolution 0.1°C
Refreshing Rate 1s

NIBP
Meets the requirements of ISO 80601-2-30
Technique Oscillometry
Operation Mode Manual, Auto, STAT, Sequence
Parameters Systolic, Diastolic, Mean
Max Measurement Time Adult/Paediatric: 180 s Neonate: 90 s
Systolic Range Adult: 25 to 290 mmHg
Paediatric: 25 to 240 mmHg
Neonate: 25 to 140 mmHg
Diastolic Range Adult: 10 to 250 mmHg
Paediatric: 10 to 200 mmHg
Neonate: 10 to 115 mmHg
Mean Range Adult: 15 to 260 mmHg
Paediatric: 15 to 215 mmHg
Neonate: 15 to 125 mmHg
NIBP Accuracy Max Mean Error: ±5 mmHg
Max Standard Deviation: 8 mmHg
NIBP Resolution 1 mmHg
Assisting Venous Puncture Yes

IBP
Meets the requirements of IEC 60601-2-34
Channels Up to 8 Channels
Sensitivity 5µV/V/mmHg
Impedance Range 300 to 3000 Ω
IBP Range -50 to 360 mmHg
IBP Accuracy ±1 mmHg or ±2%, whichever is greater
IBP Resolution 1 mmHg
PPV Range 0 to 50%
PAWP Yes
ICP Measurement Supported
Overlapping Waveforms Supported

4 Penlon SP M5 Patient Monitor


Penlon SP M5 Patient Monitor Technical Specifications
PAT I E N T M O N I T O R I N G S O LU T I O N S

C.O.
Technique Thermodilution
C.O. Range 0.1 to 20 L/min
C.O. Accuracy ±0.1 L/min or ±5%, whichever is greater
C.O. Resolution 0.1 L/min
TB Range 23 to 43°C (73.4 to 109.4°F)
TI Range 0 to 27°C (32 to 80.6°F)
TB, TI Accuracy ±0.1°C (without sensor)
TB, TI Resolution 0.1°C

PiCCo Measurement Range Coefficient of Variation


CCO 0.25 to 25.0 L/min ≤ 2%
C.O. 0.25 to 25.0 L/min ≤ 2%
GEDV 40 to 4800 ml ≤ 3%
SV 1 to 250 ml ≤ 2%
EVLW 10 to 5000 ml ≤ 6%
ITBV 50 to 6000 ml ≤ 3%

(Coefficient of variation is measured using synthetic and/or database waveforms (laboratory testing).
Coefficient of variation = SD/mean error.)
TB Range 25 to 45°C
TB Accuracy ±0.1°C (without sensor)
TI Range 0 to 30°C
TI Accuracy ±0.1°C (without sensor)
pArt/pCVP Range -50 to 300 mmHg
pArt/pCVP Accuracy ±1 mmHg or ±2%, whichever is greater

ScvO2
ScvO2 Range 0 to 99%
ScvO2 Accuracy ±3% (50 to 80%)

ICG
Technique Thoracic electrical bioimpedance (TEB)

Monitoring Parameters ACI, VI, PEP, LVET, TFI, TFC, HR, C.O., C.I., SV, SVI, SVR, SVRI, PVR, PVRI,
LCW, LCWI, LVSW, LVSWI, STR, VEPT

HR Range 44 to 200 bpm (ICG), accuracy ±2 bpm


C.O. Range 1.0 to 15 L/min
SV Range 5 to 250 ml

Penlon SP M5 Patient Monitor 5


Penlon SP M5 Patient Monitor Technical Specifications
PAT I E N T M O N I T O R I N G S O LU T I O N S

Artema Sidesteam CO2


Meets the requirements of ISO 80601-2-55
CO2 Sample Flow Rate 120 ml/min (DRYLINE II™ watertrap 90 ml/min (DRYLINE™ watertrap
(115-037385-00) for adult/paediatric) for neonate)

CO2 Sample Flow Rate Adult: 70, 100, 120, 150 ml/min Paediatric/neonate: 70, 100 ml/min
(115-020189-00)
CO2 Sample Flow Rate Accuracy ±15 ml/min or ±15%, whichever is greater
Sweep Speed 3, 6.25, 12.5, 25 or 50 mm/seconds
CO2 Range 0 to 99 mmHg
CO2 Accuracy 0 to 40 mmHg: ±2 mmHg
41 to 76 mmHg: ±5% of the reading
77 to 99 mmHg: ±10% of the reading
CO2 Resolution 1 mmHg
O2 Range 0 to 100%
O2 Accuracy 0 to 25%: ±1%
25.1 to 80%: ±2%
80.1 to 100%: ±3%
O2 Resolution 0.1%
awRR Range 0 to 150 rpm
awRR Accuracy 0 to 59 rpm: ±1 rpm
60 to 150 rpm: ±2 rpm
Apnea Time 10, 15, 20, 25, 30, 35, 40 seconds

Oridion Microstream CO2


Meets the requirements of ISO 80601-2-55
Sample Flow Rate 50 -7.5+15 ml/min
Sweep Speed 3, 6.25, 12.5, 25, 50 mm/second
CO2 Range 0 to 99 mmHg
CO2 Accuracy 0 to 38 mmHg: ±2 mmHg
39 to 99 mmHg: ±5% of the reading (0.08% increase in error for
every 1 mmHg if the reading is more than 38)

awRR Range 0 to 150 rpm


awRR Accuracy 0 to 70 rpm: ±1 rpm
71 to 120 rpm: ±2 rpm
121 to 150 rpm: ±3 rpm
Apnea Time 10, 15, 20, 25, 30, 35, 40 seconds

6 Penlon SP M5 Patient Monitor


Penlon SP M5 Patient Monitor Technical Specifications
PAT I E N T M O N I T O R I N G S O LU T I O N S

Capnostat Mainstream CO2


Meets the requirements of ISO 80601-2-55
Sweep Speed 3, 6.25, 12.5, 25, 50 mm/second
CO2 Range 0 to 150 mmHg
CO2 Accuracy 0 to 40 mmHg: ±2 mmHg
41 to 70 mmHg: ±5% of the reading
71 to 100 mmHg: ±8% of the reading
101 to 150 mmHg: ±10% of the reading
awRR Range 0 to 150 rpm
awRR Accuracy ±1 rpm
Apnea Time 10, 15, 20, 25, 30, 35, 40 seconds

Multi-Gas
Meets the requirements of ISO 80601-2-55
Gas CO2, O2, N2O, Des, Iso, Enf, Hal, Sev
Warm Up Time ISO accuracy: 45 seconds
Full accuracy: 10 minutes
Sample Flow rate Adult/paediatric: 120, 150, 200 ml/min
Neonate watertrap: 70, 90, 120 ml/min
Sample Flow rate Accuracy ±10 ml/min or ±10%, whichever is greater
CO2 Range 0 to 30%
O2 Range 0 to 100%
N2O Range 0 to 100%
Enf/Iso/Hal/Sev/Des Range 0 to 30%
awRR Range 2 to 100 rpm
awRR Accuracy ±1 rpm (2 to 60 rpm)
Apnea Time 10, 15, 20, 25, 30, 35, 40 seconds
Provide MAC value (support calibration by age)
Support two mixed gas identify and monitoring

Penlon SP M5 Patient Monitor 7


Penlon SP M5 Patient Monitor Technical Specifications
PAT I E N T M O N I T O R I N G S O LU T I O N S

BISx/BISx4
Meets the requirements of IEC 60601-2-26
Technique Bispectral Index
Impedance Range 0 to 999 kΩ
EEG Bandwidth 0.25 to 100 Hz
BIS Range 0 to 100 (BIS, BIS L, BIS R)
SQI Range 0 to 100% (SQI, SQI L, SQI R)
ASYM 0 to 100%
DSA Trend Yes

NMT
Meets the requirements of IEC 60601-2-10
Sensor Type Acceleromyography sensor
Stimulation Modes ST, TOF, PTC, DBS3.2, DBS3.3
Stimulation Current Range 0 to 60 mA
Stimulation Current Accuracy ±5% or ±2mA, whichever is greater
Stimulation Pulse Width 100, 200 or 300 µs, monophasic rectangle pulse
Stimulation Pulse Width Accuracy ±10%
Max. Output Voltage 300 V

EEG
Meets the requirements of IEC 60601-2-26
EEG Channels Up to 4 channels
Montage Mode Biopolar mode, referential mode
Max. Input DC Offset ±500 mV DC
CMRR ≥ 100 dB @ 50 Hz
Sampling Frequency 1024 Hz
Analog Bandwidth 0.5 to 110 Hz
Measurement Range 0.5 to 30 Hz
Low Filter 0.16, 0.5, 1.0, 2.0 Hz
High Filter 15, 30, 50, 70 Hz
Spectrum Analysis SEF, MF, PPF, TF, Delta, Theta, Alpha and Beta
DSA Trend Yes
CSA Trend Yes

8 Penlon SP M5 Patient Monitor


Penlon SP M5 Patient Monitor Technical Specifications
PAT I E N T M O N I T O R I N G S O LU T I O N S

RM
Technique Diff-Pressure Flow

Monitoring Parameters PEEP, Pmean, PIP, Pplat, PEF, PIF, MVe, MVi, TVe, TVi, RR, I:E, FEV1.0,
Compl, RSBI, NIF, WOB, RAW and loops

Flow Range Adult/Paediatric: ± (2 to 120) L/min


Neonate: ± (0.5 to 30) L/min
Flow Accuracy Adult/Paediatric: ±1.2 L/min or ±10% of the reading, whichever is greater
Neonate: ±0.5 L/min or ±10% of the reading, whichever is greater
Flow Resolution 0.1 L/min
Paw Range -20 to 120 cmH2O
Paw Accuracy ±3% × reading
Paw Resolution 0.1 cmH2O
MVe/MVi Range Adult/Paediatric: 2 to 60 L/min
Infant: 0.5 to 15 L/min
MVe/MVi Accuracy ±10% × reading

MVe/MVi Resolution 0.01 L/min (MVe/MVi < 10 L/min)


0.1 L/min (MVe/MVi ≥10 L/min

TVe/TVi Range Adult/Paediatric: 100 to 1500 ml


Infant: 20 to 500 ml
TVe/TVi Accuracy Adult/Paediatric: ±10% or ±15 ml, whichever is greater
Infant: ±10% or ±6 ml, whichever is greater
TVe/TVi Resolution 1 ml
awRR Range 4 to 120 rpm
awRR Accuracy ±1 rpm (4 to 99 rpm)
±2 rpm (100 to 120 rpm)
awRR Resolution 1 rpm

Provides VCO2, VO2, MVCO2, MVO2, EE, RQ parameters, when monitoring with Sidestream CO2 or AG module
configured with the paramagnetic O2 sensor.

Penlon SP M5 Patient Monitor 9


Penlon SP M5 Patient Monitor Technical Specifications
PAT I E N T M O N I T O R I N G S O LU T I O N S

tcGas
Interfaces with TCM CombiM, TCM TOSCA or SenTec SDM monitor
tcpCO2 Range 5 to 200 mmHg
tcpCO2 Accuracy Better than 1 mmHg (1 or 10% CO2)
TOSCA Sensor 92, tc Sensor 54:
Better than 3 mmHg (33% CO2)
Better than 1 mmHg (1 or 10% CO2)
tc Sensor 84:
Better than 5 mmHg (33% CO2)
tcpO2 Range 0 to 800 mmHg
tcpO2 Accuracy Better than 1 mmHg (0% O2)
Better than 3 mmHg (21% O2)
tc Sensor 84:
Better than 5 mmHg (50% O2)
Better than 25 mmHg (90% O2)
SpO2 Range 0 to 100%
SpO2 Accuracy ±3% (70 to 100%)
PR Range 25 to 240 bpm
PR Accuracy ±3 bpm
Power Range 0 to 1000 mW
Power Accuracy ±20% of reading

EWS (Early Warning System)

Scoring System NEWS, MEWS, IPS with customisation.


Support sending EWS results to CMS

Data Review

Trends Data 120 hours with resolution no les than 1 minute.


4 hours with resolution @ 5 seconds

Alarm Events 100 events and associated waveforms


Arrythmia Events 100 events and associated waveforms
OxyCRG Events 100 events and associated trends
NIBP 1000 sets

Interpretation of Resting 20 sets


12-lead ECG Results

Full Disclosure 48 hours at maximum. The specific storage time depends on the
waveforms stored and the number of stored waveforms.

Minitrend Yes

10 Penlon SP M5 Patient Monitor


Penlon SP M5 Patient Monitor Technical Specifications
PAT I E N T M O N I T O R I N G S O LU T I O N S

Alarms
Audible Indicator Yes, 3 different alarm tones, and prompt tone
Visible Indicator Red/yellow/cyan LED, and alarm message

Wi-Fi Communications
Protocol IEEE 802.11a/b/g/n
Frequency Range 2.4 to 2.483 GHz, 5.15 to 5.35 GHz, 5.47 to 5.725 GHz, 5.725 to 5.82 GHz

Interfacing and I/O Devices

1 × AC power connector
Main Unit
1 × DVI-D port
1 × Network connector
100 Base-TX, IEEE 802.3
10 × USB 1.1 connector
1 × SMR connector
CF card connector
1 × Nurse call connector
Micro-D port analog output and defibrillator
1 × Synchronisation signals
5 × Integrated module slots

Barcode Scanner Support 1D barcode, standard USB


Keyboard and Mouse Support wire and wireless type, standard USB

Thermal Recorder 3 traces (paper 50 mm width, 20 m length)


25 mm/s, 50 mm/s speed

Network Printer Support

Power
Line Voltage 100 to 240 VAC (±10%), 2.5 to 1.4 A
Frequency 50/60 Hz
2 × Rechargeable lithium-ion battery, 4500 mAh, 11.1 VDC
Battery
> 5.5 hours run time (typical)

Charge Time 5 hours to 90%, 6 hours to 100%

Penlon SP M5 Patient Monitor 11


Penlon SP M5 Patient Monitor Technical Specifications
PAT I E N T M O N I T O R I N G S O LU T I O N S

Environmental Requirements

Temperature Operating: 0 to 40°C (32 to 104°F)


Storage: -20 to 60°C (-4 to 140°F)

Humidity Operating: 15 to 95% (non condensing)


Storage: 10 to 95% (non condensing)

Barometric Operating: 427.5 to 805.5 mmHg (57.0 to 107.4 kPa)


Storage: 120 to 805.5 mmHg (16.0 to 107.4 kPa)

facebook.com/PenlonGlobal linkedin.com/company/penlon-ltd twitter.com/PenlonGlobal

Doc. No. SPM5 0119TS / February 2019. Penlon, InterMed and Prima are trademarks of Penlon Limited. All other trademarks are the property of their respective owners.

Part of the InterMed Group © Penlon Ltd. 2019 All rights reserved

Penlon Limited General International Sales UK Sales Technical Support


Abingdon Science Park t +44 (0) 1235 547000 t +44 (0) 1235 547001 t +44 (0) 1235 547036 t +44 (0) 1235 547060
Barton Lane, Abingdon f +44 (0) 1235 547041 f +44 (0) 1235 547021 f +44 (0) 1235 547023 f +44 (0) 1235 547061
OX14 3NB, UK w www.penlon.com e [email protected] e [email protected] e [email protected]

You might also like