Service Manual

Description
Document HE41.2_7
Hermes Service Manual Revision 7
Date 12/12/2017 Page 1 OF 27

HERMES URODINAMIC EQUIPMENT

Ref: 98600000

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Contents

DESCRIPTION 3
HARDWARE TECHNICAL SPECIFICATIONS 4
Flow sensor 4
Puller 4
EMG (wireless) 4
Infusion pump 5
Air Pump 5
Remote Control 5
Video urodynamics 6
Urodynamics Kit 6
Micturition Chair 6
Automatic Leak Detector 7
PC, Monitor, Printer 7
Pressure Transducers for use with air-charged catheters 7
Software characteristics 7
PARTS OF THE EQUIPMENT 9
UROBOARD TECHNICAL DESCRIPTION 12
Features 12
Introduction 12
Board Monitoring Unit 13
Infusion pump driver 14
Puller driver 14
Analog section 14
USB / Communication Interface #1 15
Connectors 15
Uroboard Specifications 25

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DESCRIPTION

The following investigations and analysis can be performed:

- Mictiometry (Uroflowmetry)

- Filling Cystometry

- Voiding Cystometry (Pressure- Flow studies)

- UPP (Urethral Pressure Profiles, Rest & Stress

- EMG (Electromyography) - wireless

- Automatic Leak Detection

- Video-urodynamics

- Anorectal Motility Studies

- Biofeedback (Adult & paediatric)

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HARDWARE TECHNICAL SPECIFICATIONS

1) Flow sensor - wireless (optional) or wired, specifically designed & sensitive for low flow-rates
(ie paediatric or obstructed flow).

Technical Data

Capacity: 3kg
Input Impedance: 415 Ohms
Output Impedance: 350 Ohms
Insulation: >2 GOhms
Precision: +/- 0.25 ml
Cleaning: Replaceable plastic covers
Control/indication Led.

2) Puller - To allow urethral pressure profile studies. Control from software (start/stop &
adjustable speed). Mounted on a fully adjustable stand (vertical/horizontal). Catheter holder is
removable and can be sterilised via autoclave.

Technical data

Length: 35 cm
Direction: Double
(pull/push)
Cleaning: Autoclave

3) EMG (wireless) - Wireless Bluetooth connection. Separate module, connects to main

system input via USB extension cable. Vaginal and rectal probes available. ‘Full Wave’ or
‘Envelope’ signal.

Technical Data

1 EMG Channel
2 electrodes, 1 reference electrode.
Patient input protection: ~6kOhms
Input range: 1mV full scale
Input resolution: >100nV (averaged)
Acceptable DC voltage: 600mV maximum
Input impedance: 1010 ohms // 1pF
Input impedance imbalance: >40%
Common mode rejection: >100dB.
Bandwidth: 10Hz~1000Hz
Optional Notch: 50Hz
Input referred noise level: 2µV (averaged)

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4) Infusion pump – 3 roller peristaltic fillng pump. Software control (start/stop & speed
selection). A seperate filling volume sensor calculates exactly how much fluid has been infused
into patient.
Technical data

Filling range: 1-150 ml/min

Tubing: Ref 288705 from Albyn Medical

5) Air Pump – automatic air pump which maintains a constant pressure inside a pressure-
infusor - to regulate the infusion rate required for UPP studies. Integrally mounted inside the
Hermes unit, with an accessible connector for connection to a pressure infusor.

Technical data

Voltage: DC6V
Software controlled: Start/stop and pressure required
Tubing and pressure infusor available from Albyn Medical

6) Remote Control – Hand-held remote control to allow system operator to control Hermes
urodynamics system without having to touch the PC/mouse.

Functions

Recording start/stop
Pump start/stop
Puller start/stop
Video clip start/stop
Record video snapshot
Zero channels
5 additional buttons (1-5) that can be programmed by the user

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7) Video urodynamics – allows x-ray images to be combined with the urodynamics traces.
Display/record/print options all available within Hermes software. X-ray system is connected to
Hermes via an adapter cable.

Technical data

Composite video input (RCA/Phono) PAL, SECAM, NTSC

S-Video input (mini-DIN) PAL, SECAM, NTSC
Adapter cable (BNC to RCA) supplied

8) Urodynamics Kit – Pressure transducers for urodynamic testing. Colour coded labels and
cables (Vesical, Adbominal and Urethral channels). Auto 100mmHg test / calibration button.
Fitted to bracket/clamp.

Technical data

Method: Water filled

Sensitivity: 5.0 Nominal uV/V/mm Hg
Range: -50 – 350mmHg
Reusable transducer (single use dome).

9) Micturition Chair – Height adjustable, folding arms, detachable seat and cover, removable
funnel. Micturition stand – for male voiding studies, height adjustable, removable funnel.

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10) Automatic Leak Detector – detects leaks during procedure and Hermes software
automatically marks trace with a ‘Leak’ event.

Technical data

Detection method: Temperature

Number of detections: Unlimited
Compatible catheters: 6Fr - 10Fr

11) PC, Monitor, Printer – latest specification, All in one Lenovo Thinkcentre E93z, printer
Canon MG3550.

12) Pressure Transducers for use with air-charged catheters.

Technical Data

Method: Air-charged
Connector: Lemo 18 pin
Sensitivity: 5.0 Nominal uV/V/mm Hg
Drift: <1.5 mmHg over 4 Hrs

13) Software characteristics:

 Windows platform, multi-language.

 Powerful SQL Server database.

 Standards and terminology as according the the ICS (International Continente Society)

 Nomograms  Liverpool, ICS, Pediatric, Siroky, Abrams-Griffiths, Werner Shaffer,

Pressure-Flow loop, Pressure v Volume, Compliance.

 NDL Security Protocol – no data loss even in the event of power failure during study.

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 Reports 100% user-configurable, using Microsoft Word format.

 Connectivity to Hospital information system and PACS DICOM work-list & DICOM
Storage

 Rehabilitation software – Biofeedback for adult and paediatric usage, using surface,
needle or plug electrodes.

 Procedure setup – user configurable procedures, traces, colours, layout etc.

 Event markers – user configurable toolbars, and event markers (icons and/or text)

 Archiving capabilities – possibilities to export/import datafiles to other PC’s using Albyn

Medical software.

 Automatic database backup

 Network capability

 Activity report

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PARTS OF THE EQUIPMENT

“All in one” Computer. Integrated

computer.

Monitor arm

Keyboard try: New model with

wireless mouse and touch pad

Printer tray

Hermes base with double

medical grade transformer

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Pressure transducers

Wired flowmeter

Puller
connection

Wireless flowmeter connected through XBee connection (Placed in the back of the
Hermes near the filling sensor)

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Infusion pump

Step by step motor to

infuse liquid inside
the bladder

Filling sensor

This sensor measures the unfunded

volume inside the bladder through a load
cell. Maximum weight 3 Kg.

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UROBOARD TECHNICAL DESCRIPTION

This part of the manual describes the characteristics, operation, and use of the
Electronic board.

Features
 Contains all the necessary circuitry for standard urodynamics tests, rectal manometry
and even some simple GI investigations.
 Wide input range power supply, with on board DC/DC step down converters.
 Low power consumption even when the pump driver is active, allowing battery operation
for long periods of time.
 Analog front end includes a medical grade isolation on all available inputs,
 24 bits, uktra low noise on board analog to digital converter and multiplexer:
 3 pressures grouped in a single connector
 2 versatile inputs with automatic transducer’s type detection
 1 infusion weight transducer
 1 on board air pressure transducer.
 High current Infusion pump driver, including an enhanced micro stepping controller
 On board puller stepper motor driver, also with a micro stepping controller
 High speed DSP controller, running a multi task real time operating system dedicated to
embedded systems
 Safety issues are addressed by the Board Monitoring Unit, permanently checking the
DSP for normal operation, capable to shutdown the Uroboard.
 2 communications interfaces provided: USB V2.0 and Wireless XBee 811.15.4.
 Unique serial number for software security.

Introduction
The Uroboard has been designed mainly for Urodynamics investigations and includes all the
necessary peripherals and functions for that specific medical area. This doesn’t limit the
Uroboard to urodynamics, rectal and some simple GI procedures can easily be performed
without any changes.
Low power consumption and compact layout design makes long term battery operation
possible, even with the infusion pump activated.
The Uroboard requires a connection to a PC running the Albyn Medical Phoenix Software.

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Board Monitoring Unit

The Board Monitoring Unit (BMU) is securing the Uroboard by monitoring the DSP process and
the most important power supplies. The Uroboard running status is displayed using several
bicolour Green/Orange LEDs having the following meaning:

Off: function not used

Steady green: function is ready
Blinking green: Function is in use
Steady orange: function is not ready

Blinking orange: function failure.

Blinking orange all together: DSP system failure.

System Air Pump

Infusion Pump Puller

Analog inputs
Communication
Communication Interface #1 USB
Interface #2 XBee

Figure 1: Uroboard's LEDs

There is one LED for the whole DSP system and one for each major installed peripheral:
infusion pump, puller, analog inputs, air pump and one for each communication interface (Note
that these last two are managed by the communication interface itself).
The BMU is build around a standalone RISC low power processor from Texas Instrument U2,
independently powered by a linear 3.3V regulator U1. This gives the ability to U2 to run even in
case of major power supply failure on other digital areas on the Uroboard.
U2 is connected to the DSP chip with a fast SPI bus, the DSP being the master, the msp430 U2
being the slave. The DSP sends command requests on peripherals and information on its own
process to the BMU, and the BMU returns board monitored values to the DSP. The DSP is
supposed to update the BMU at regular paces. Whenever this pace is irregular or stopped, the
BMU enters the safety mode by shutting down all peripherals.
The board preferences functionality is also devoted to the BMU, these preferences are stored in
the info flash section of the msp430.
U2 firmware has voluntarily been kept very simple to minimize code size thus reducing the
firmware’s risk of failure. This firmware is also secured by a hardware watchdog that resets the
BMU in case of firmware failure. Upon reset, the BMU is places in safety mode.
The msp430 firmware can be uploaded at production time using the JTAG connector U1 or the
USB interface with the Uroboard Service Application (See corresponding chapter). This same
application can upgrade the firmware from the host PC.

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Infusion pump driver

The infusion pump head is powered by a high power bipolar stepper motor. The Uroboard is
using a specific integrated circuit to control this stepper motor, allowing a large service voltage
range and a full control of the current. The controller is a complete microstepping motor driver
with build-in translator, and is fully protected against faults, microstepping capable with
precision of 1/16 of a step, and includes a current decay control scheme that helps reduction
the power consumption.
The pump motor is connected on J4. J3 connector provides some extra inputs/outputs for
extended safety features which are not yet implemented. Due to the high current pulses U7 and
current sense resistors R68 and R75 can get quite hot when running the motor for long periods.
A fan, firmware activated, helps cooling down these components.
All the pump driver digital signals are under the control of the DSP but the enable signal is
managed by the BMU, zeroing the risk of leaving the pump running if the DSP fails.

Puller driver

The Puller is powered by a miniature geared bipolar stepper motor. This motor is connected to
CN4, directly to the microstepping controller U25 (same chip as the infusion driver). As for the
pump, all signals are under DSP control but the enable signal is driven by the BMU for safety
reasons. CN4 provides two control lines for remote controls if ever some are needed.

Analog section

The Uroboard has a very low noise high resolution oversampling successive approximation
analog to digital converter with a medical grade secondary isolation. The ADC resolution is
24bits, and at Uroboard acquisition rate, the noise free resolution is close to 17 bits.
Digital isolation is provided by means of U8 and U10, and power supply isolation is the
responsibility of the DC/DC converter U13. All of them are medical grade 60601 certified
components.
Analog section power supply is provided by two low noise linear regulators, U12 is the digital
3.3V regulator and U14 is the analog +5V regulator which is switched only when the ADC is in
use.

External inputs are available on MEDI-SNAP series connectors, CN1 provides 3 pressures input
in a compact 14 pins socket and CN2 and CN3 are two versatile inputs. The ADC reads the
code input from these connectors to identify the type of connected transducer.
There are also two internal inputs, one for the weight transducer load cell (J5) and an on board
air pressure transducer. All these inputs have EMI filters fitted very close to their respective
connectors, followed by a low pass filter and some protection resistors, before entering the
analog multiplexor build-in U9.

U11A and U11B are symmetrically amplifying the signal from the multiplexer output before it
enters the ADC.

A resistor divider takes a part of the analog voltage for the ADC to use it as a reference voltage
for the conversion process. This ratiometric measurement helps keeping the noise level very
low, provided the connected transducers are powered with the same power supply.

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The ADC is clocked directly from the DSP chip through the isolation barrier, allowing for a wide
range of sampling rates. Actual sampling rates in use for Urodynamics are 25 sps. and 50 sps..

The ADC starts conversion upon ADS_START assertion by the DSP, when conversion is done
the ADC asserts the ADS_DRDY line. The DSP reads the result registers in the ADC chip from
the SPI bus. This sequence is repeated for every selected channel as long as ADS_START
remains asserted.

USB / Communication Interface #1

The Uroboard can be directly connected to a PC through the USB interface. This USB interface
can be use to upgrade the DSP and BMU firmwares from the host PC without any other
external tool, or to perform studies.
Note that the host interface type is selected during production by setting up the preferences
according to the build system’s requirements.

IMPORTANT NOTICE: if the PC is intended use is to perform real time studies on patients, the
PC is required to have or to be connected to a medical grade power supply. Never run the
Uroboard connected to a patient from an unknown PC configuration.

The Uroboard uses a dedicated USB/RS232 integrated chip U26, containing all the necessary
circuitry and clocks. When connected, the USB host takes USBSCI_ON signal high and enables
U26 interface. The status LEDs blinks according to the input/output data flow. Apart from
standard RS232 signals, U26 has some general purpose IO lines which are used to change the
start-up sequence of the DSP or the BMU, allowing special bootstrap modes to be entered for in
field programming.
U26 features few bytes of non volatile memory which can be read from the host driver side. In
the Uroboard design, this memory is used to identify the Uroboard and gives some setup
instructions to the PC driver –baud rate, name, type of frames....

J16 is an extension connector that can override the on board USB interface and directly access
the DSP’s UART and all the other start-up signals.

Connectors

USB/Communication Interface #1
PCB Manufacturer Type Mating connector
ref.
J15 MOLEX PICO-SPOX series vertical header 87439-0600

Pin Signal
1 +5v dc
2 Data -
3 Data+
4 Ground
5 Ground
6 Ground

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Communication Interface #1 Extension

PCB Manufacturer Type Mating connector
ref.
CONNECTOR HEADER 20POS 5MM
J16 HIROSE DF12 series 20 positions
0.5MM

Pin Signal
1 Ground
2 Ground
3 +5Vdc
4 +3.3Vdc
5 Ground
6 USB on
7 Ground
8 Data Terminal Ready
9 Transmit Data (DSP Uart input)
10 Green LED
11 RS232 RTS
12 Yellow LED
13 Receive Data (DSP Uart output)
14 DSP boot option
15 Clear To Send
16 BMU boot option
17 Ground
18 Power On Reset
19 Ground
20 Ground

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DSP JTAG interface

PCB Manufacturer Type Mating connector

ref.
J2 Std. 14 pins 2.54mm double row header

Pin Signal
1 TMS
2 TRSTn
3 TDI
4 GND
5 +5Vdc
6 Not used
7 TDO
8 GND
9 TCK
10 GND
11 TCK
12 GND
13 BMU0
14 BMU1

Power Supply

PCB Manufacturer Type Mating connector

ref.
J8 TYCO ELEC. Universal MATE_N_LOK 1-794184-1

Pin Signal
1 +Vin
2 GND

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Infusion Pump

PCB Manufacturer Type Mating connector

ref.
J4 MOLEX MICRO-FIT 3 series 43025-0400

Pin Signal
1 Motor phase 1 A
2 Motor phase 1 B
3 Motor phase 2 A
4 Motor phase 2 B

Infusion pump safety extension

PCB Manufacturer Type Mating connector

ref.
J3 MOLEX PICO-SPOX series vertical header 87439-0600

Pin Signal
1 Emitter Anode
2 Emitter cathode
3 Sensor collector
4 Sensor emitter
5 Reed contact input 1
6 Reed contact input 2

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LCD Interface

PCB Manufacturer Type Mating connector

ref.
J6 MOLEX ZIF 1mm, 24 pins ZIF flat cable

Pin Signal
1 Reset
2 Read strobe
3 Write strobe
4 Chip Select
5 A0
6 – 13 8 bits data bus D0 to D7.
14 +3.3Vdc
15 Ground
16 LCD Contrast input
17 Not connected
18 Touch panel SPI clock input
19 Touch panel SPI SOMI
20 Touch panel SPI SIMO
21 Touch panel SPI chip select
22 Touch panel interrupt output
23 +5Vdc
24 Low side backlight switch

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Keypad interface

PCB Manufacturer Type Mating connector

ref.
J7 MOLEX PICO-SPOX series vertical header 87439-0600

Pin Signal
1 Keypad Row 1
2 Keypad Row 2
3 Keypad Row 3
4 Keypad Column 1
5 Keypad Column 2
6 Ground

Power Switches

PCB Manufacturer Type Mating connector

ref.
J9 – J14 MOLEX PICO-SPOX series vertical header 87439-0200

Pin Signal
1 Positive Power Output
2 Low Side Switch

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BMU JTAG Interface

PCB Manufacturer Type Mating connector

ref.
SAMTEC / FTR-
J1 1.27, double row header connector
105-02-G-D

Pin Signal
1 TDO/TDI
2 +3.3V BMU
3 TDI/TCLCK
4 Not Connected
5 TMS
6 Not Connected
7 TCK/P2.4
8 P2.3
9 Ground
10 Not Connected

Infusion Weight Transducer

PCB Manufacturer Type Mating connector

ref.
J4 MOLEX PICO-SPOX series vertical header 87439-0400
Pin Signal
1 Ground
2 Negative Input
3 Positive Input
4 +5Vdc excitation voltage

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Communication Interface #2 Extension

PCB Manufacturer Type Mating connector

ref.
CONNECTOR HEADER 20POS 5MM
J18 HIROSE DF12 series 20 positions
0.5MM
Pin Signal
1 Ground
2 Ground
3 +5Vdc
4 +3.3Vdc
5 Ground
6 Not Connected
7 Ground
8 Data Terminal Ready
9 Transmit Data (DSP Uart input)
10 Green LED
11 RS232 RTS
12 Yellow LED
13 Receive Data (DSP Uart output)
14 Not Connected
15 Clear To Send
16 Not Connected
17 Ground
18 Not Connected
19 Ground
20 Ground

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XBee Upgrade Interface

PCB Manufacturer Type Mating connector

ref.
J17 MOLEX PICO-SPOX series vertical header 87439-0600

Pin Signal
1 DIN
2 DOUT
3 DTR
4 RTS
5 Reset
6 Ground

Pressure Block Input

PCB Manufacturer Type Mating connector
ref.
S21M07P14MCC0657S
CN1 ODU G51M07-P14QC00-0070 +
701023207965050

Pin Signal
1 Pressure Transducer #1 Ground
2 Pressure Transducer #1 Negative Input
3 Pressure Transducer #1 Positive Input
4 Cable shield grounding point
5 Code input
6 Pressure Transducer #3 Negative Input
7 Pressure Transducer #3 Positive Input
8 Pressure Transducer #3 Ground
9 Pressure Transducer #2 Negative Input
10 Pressure Transducer #2 Positive Input
11 Pressure Transducer #2 Ground
12 Pressure Transducer #1 +Excitation Voltage
13 Pressure Transducer #3 +Excitation Voltage
14 Pressure Transducer #2 +Excitation Voltage

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Vesatile Inputs
PCB ref. Manufacturer Type Mating connector
S21M07P06MFD0527S
CN2/CN3 ODU G51M07-P06QF00-0030 +
701023203965040

Pin Signal
1 Cable shiel ground
2 Code input
3 Transducer Ground
4 Transducer Negative Input
5 Transducer Positive Input
6 Transducer +5V excitation voltage

Puller
PCB Manufacturer Type Mating connector
ref.
S21M07P08MFD0527S
CN4 ODU G51M07-P08QF00-0060 +
701023206965040

Pin Signal
1 Forward digital input
2 Backward digital input
3 Ground
4 Ground / Cable shield
5 Motor phase 2B
6 Motor phase 2A
7 Motor phase 1B
8 Motor phase 1B

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Uroboards Specifications

Power Supply
 +9Vdc to 25Vdc input range; MUST be connected to an Albyn Medical recommended
medical grade 60601 certified power supply
 Current consumption 150mA @ 24Vdc (3.6W) excluding infusion pump and puller motor
currents
 Current consumption 150+50mA @ 24Vdc (4.8W) when puller is on (motor: HSI 31651)
 Current consumption 150+400mA @ 24Vdc (13.2W) when infusion pump is on (motor:
ST 6018 M 2008)

Digital Signal Processor

 32 bits DSP, 150MHz, 256Mb to 512Mb RAM, running DSP/BIOS Texas Instruments
real time multi tasks operating system
 Automatic and direct in the field upgradable firmware.
 15s full speed data buffer capability and communication auto recovery, preventing
procedure break on communication failure.

Board Monitoring Unit

 Low power RISC processor dedicated to the on board risk management, ensuring
patient safety on DSP or host PC failure.
 Automatic and direct in the field upgradable firmware.
 Displays Uroboard’s status on user visible LEDs giving precise information on any
possible issue.

USB / Communication interface #1

 USB 2.0 Full Speed compatible
 UHCI / OHCI / EHCI host controller compatible
 Direct in the field DSP and BMU firmware upgrade
 Can be selected as the host interface but the host PC MUST comply with 60601
medical standards and being approved by Albyn Medical technical services.

User interface
 8 bit bi-directional data bus, one address bus, 8051 control bus.
 3.3V digital logic
 80 mA maximum backlight current.
 Touch panel interface with integrated controller.
 6 keys, 3 rows, two columns keypad available interface.

Infusion Pump Driver

 Bipolar stepper motor driver up to 1/16 step mode.
 Max 24V @ +/-1.7A per phase driving capability.
 Thermal and cross over current protection.
 Optional rotation and door sensor interface.

Puller Driver
 Bipolar stepper motor driver up to 1/16 step mode.
 Max 24V @ 100mA per phase driving capability.
 Thermal and cross over current protection.
 Forward and backward command signals for remote operation

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Isolated Analog to Digital Unit

 Medical grade secondary isolation barrier,
 24 bits, successive approximation oversampling analog to digital converter
 Per channel digital filter assignment
 Selectable 25 or 50 samples per second sampling rate,
 0.0003% integral nonlinearity
 Ultra low noise.

Pressure inputs
 3 pressure inputs grouped on the same connector
 +5Vdc transducer excitation voltage
 Compatible with standard pressure transducers (5µV/V/mmHg)
 0.022 cmH2O resolution
 0.1 cmH2O noise free resolution.
 +/- 500mmHg full scale
 FIR Digital filter defaults to 5Hz.

Versatile inputs
 Automatic transducer type detection,
 Automatic range and digital filter adaptation.
 +5Vdc power supply output,
 Fully differential input.
Check versatile connected transducers specs for other detailed information.

Flow Scale (versatile input)

 0.1 ml noise free resolution.
 3.2L full scale
 FIR Digital defaults to 0.5Hz.

Weight transducer
 0.1 ml noise free resolution
 3.2L full scale
 FIR Digital filter defaults to 0.01Hz.

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Dimensions
 Overall dimensions: L 131mm x W 119mm x H 40mm
 Detailed dimensions:

Figure 2: Uroboard dimensions

Weight
 105g.

Environmental Conditions
Transport and storage:
 Ambient temperature: -10°C to +40°C
 Humidity: 10% to 100%
 Atmospheric pressure: 50 kPa to 106 kPa

Operation
 Temperature: +10°C to +40°C
 Humidity: 30% to 75%
 Atmospheric pressure: 70 kPa to 106 kPa

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