MP3070 & MP3126 Stimulus Extension Cable Manual Ver 1.6

Stimulus Extension Cable MP3070 (12m) & MP3126 (24m)

CONTENTS 1.

PRODUCT DESCRIPTION... 2 1.1 Warnings and Precautions... 3 2. HOW SUPPLIED... 4 3. DESCRIPTION ... 5 3.1 General ... 5 3.2 Specifications ... 6 3.2.1 Product Specifications ... 6 3.2.2 Cable specifications ... 6 3.2.3 Cable Construction ... 7 3.2.4 Cable connections: ...Error! Bookmark not defined. 3.3 Labelling ... 8 3.3.1 Product Label (Placed on plastic bag): ... 8 3.3.2 Labels on the product ... 8 3.3.3 Appearance - Product picture: ... 8 4. INSTALLATION ... 9 4.1 Cable placement ... 9 4.2 Installation Testing: ... 11 5. USER INSTRUCTION ... 11

1. PRODUCT DESCRIPTION This Stimulus Extension Cables MP3070 and MP3126 are supplied for use with all version and configurations of the EPS320 Cardiac Stimulator, for use with the following stimulus output connection accessories: 1. Stimulus Connection Box MP3014 2. Stimulus Multiplexor Box, MP3086 The MP3070 and MP3126 extend the length of the connecting cable between the Stimulus Generator Unit (SGU) and the Stimulus output connectors from 2.5m (8 feet) to 14.5 m (48 feet) and 26.5 m (87 feet) respectively.

2

Stimulus Extension Cable MP3070 (12m) & MP3126 (24m)

1.1 Warnings and Precautions Warning: This product is not a life support device. Use approved temporary pacemaker generators connected directly to intra-cardiac leads for patients requiring life-support pacing. Warning: These extension cables form part of the Class CF patient isolated circuit. In order to prevent electrocution hazards to the patient through conducted or electromagneticaly induced leakage currents, MP3070 and MP3126 cable installation: (i) (ii)

must be appropriately insulated from any nearby mains wiring to prevent injection of mains voltage through broken insulation, must be installed away from mains voltage–energised cables and

(iii) should be installed in a manner whereby < 10m (30 feet) of cable is in contact with earthed surfaces such as within metal tubing or concrete channels. Cable must be installed so it remains dry and is never exposed to wet grounded surfaces. (iv) May be ideally installed in plastic conduits Final installation must be acceptance tested by biomedical engineer for Patient Applied Part, Class CF device, including mains-applied patient leakage current measurements (IEC60601-1 Clause 19.2b). MP3070 o r M P 3 1 2 6 MP3070 or M P 3126 Mains Cable

Do not install parallel to mains cables

Do not install on or within grounded conduits

M P 3 0 7 0 o r M P 3126

Install within insulated channels with other data / signal cables

Precaution: Where stimulus extension cabling is required to cover distances greater than 12m (40 feet), consideration should be given to the use of split-system installation as shown below:

MP3074 PSU

PACE OUT PUT

BACKUP ENA LBE

P a

e cV -

a B

t e r y

Q RS Sen s e

PA OCEF ON/

V ENTRICL E

PCP a c e Con t ro l

CH E C K LEAD WA RN I NG Potentiall y d a n g eur os o u t p u t . For eusbqualif y ied ca r d ioogl i sot n l y .

C ur r e n t ( m A)

`

!

! P l ung ti op a c eVentri c l e : 100 bpm @ 5 mA.

To Local Isolation Transformer

EPS320 Cardia cS m ti u l aot r

Stimulus Generator Po we r Backup Manual N o rUnit m a l P a c e Output LE Ds P ace Green socket MP3008

EP Recording Equipment

EM PACE ER GENC YF XI ED OU TPUT

CH E C K LEAD

AT R IUM

Pac e I n t e r va l ( ms )

Ba t t er y Low

E me rge ncy P acin g

Control Room

Ba t t e r y Po w er

Patient Area

B AC KU P MA NU AL PA CE C ON T RO L

Ma i n s Po w er

Power

Monitor

COM

Kbrd

Ventricle Atrium Stimulus Connection Box,MP3014

MP3084 - 12m(40ft) MP3084 - 24m(80ft) Cable, Serial RS232

Figure 1 Split system stimulator installation using serial cable MP3084

3

Stimulus Extension Cable MP3070 (12m) & MP3126 (24m)

Precaution: Always inspect the product prior to use for evidence of damage to the device, associated cables, and connectors; do not use if product appears damaged. Precaution: Protect cables and connectors from ingress of liquids and body fluids. Components may be externally cleaned using a cloth dampened with standard hospital equipment cleaning agents such as 10% ammonia or 10% bleach, isopropyl alcohol, Cidex, or mild soap. Do not spray or pour agents onto the equipment and do not use acetone solvents.

2. HOW SUPPLIED

Stimulus Extension Cable Item

Part No.

Stimulus Extension Cable MP3070, 12 m (40 feet)

MP3070

Stimulus Extension Cable Manual

MP3132

Packed

OR Stimulus Extension Cable Item

Part No.

Stimulus Extension Cable MP3126, 24 m (80 feet)

MP3126

Stimulus Extension Cable Manual

MP3132

Packed

Cable Batch Number:

Packed By: Date:

4

Stimulus Extension Cable MP3070 (12m) & MP3126 (24m)

3. DESCRIPTION

3.1 General The standard EPS320 Cardiac Stimulator consists of a Personal Computer (PC) and a Stimulus Generator Unit (SGU) which are usually located together either in a control room where it is operated by support staff, or next to the bedside in the EP Laboratory where it may be controlled by the cardiologist directly. Where the Stimulator is located in the control room, the stimulator’s output is typically routed to a connection box in the patient area via a Stimulus Cable from which it is connected to the Stimulus Inputs of the EP Recording equipment via a third party stimulus cable.

Hospital Electrophysiology Laboratory

Patient Area

Patient

Control Room

Remote Slave Keyboard / Display

EP Recorder

Micropace EPS320 Stimulator

SGU

EP Recorder AMPLIFIER

Stimulus Connection Box MP3014 OR Stimulus Multiplexer Box MP3086

Stimulus Extension CableMP3070 (12m) OR MP3126 (24m)

Micropace provides two alternative connection boxes, both terminated in shrouded 2mm banana sockets: (i) the Stimulus Connection Box, MP3014 which has 2 + 2 terminals for two channel stimulation and (ii) MP3086 which features 4 x 2 terminals for four channel stimulation. Each connection box has a 2.5m (8 foot) cable with a 4 pin green connector for insertion into the SGU. This extension cable is provided for insertion between the SGU and the connection box to extend the remote location of the connection box by 12m (40 feet) (MP3070) or 24m (80 feet) (MP3126).

5

Stimulus Extension Cable MP3070 (12m) & MP3126 (24m)

3.2 Specifications 3.2.1 Product Specifications Product batches 2355 and above use a custom manufactured cable for low conductor-t o-external capacitance and extra structural protection provided by a second outer polyolefin fire-retardant jacket. Micropace Catalogue Part No.

MC3070

MC3126

Micropace Component No.

MC3070FR-1

MC3126FR-1

Length

12 m (40 feet)

24 m (80 feet)

Cable

Hartland HCX-248HFS

Hartland HCX-248HFS

Colour

Black outer jacket

Black outer jacket

Green Redel 4 pin, single key plug and socket

Green Redel 4 pin, single key plug and socket

Connectors

Single conductor resistance

1.0 Ohms

2.0 Ohms

Atrium: 0.56 nF

Atrium: 1.1 nF

Ventricle 0.57nF

Ventricle 1.1nF

0.78 nF

1.6 nF

N/A (no sheath)

N/A (no sheath)

Capacitance – between channel(s) and conductive conduit in contact with cable along entire length

0.19 nF (one pair) 0.23 nF (both pairs)

0.38 nF (one pair) 0.46 nF (both pairs)

Capacitance between channel(s) and water surrounding cable.

1.0 nF (one pair) 1.3 nF (both pairs)

2.0 nF (one pair) 2.6 nF (both pairs)

Capacitive – +ve to –ve terminals, both channels Capacitance – between channels A and V Capacitance – between either channel and shield (ungrounded)

3.2.2 Cable specifications Specification

Description

Cable Manufacturer and Model number

Hartland Cables – HCX-248HFS

Cable type

Unscreened two twisted pair

Nominal outer diameter

7.5 mm

Connectors

Green Redel 4 pin, single key plug and socket

Screening

No screening

Cable integrity

Inner jacket insulation manufacturer tested at 500V. Flame retardant grey PVC V75 manufactured to requirements of AS3147 and AS3191. Outer jacket insulation Polyolefin, ECCOH™ 5500 Flame Retardant, Bromide-free

Cable approvals

Conductor insulation conforms to requirements of UL1674, UL1007. Conductor Insulation spark tested to 1.8 kV A.C.

6

Stimulus Extension Cable MP3070 (12m) & MP3126 (24m) 3.2.3 Cable Construction

O/A 19mm melinex (AAID003) OD= 6.0 mm

Outer sheath Polyolefin, ECCOH™ 5500 ID= 6.0 mm OD= 7.5 mm

O/A 19mm Double melinex (AAID003) OD= 4.7 mm

Pin Number 2 twisted pair wires 4 xHC0328 Sheath= Polyethylene Core dimension 7/0.2 tinned annealed copper, 24 AWG OD=1.28 mm Pair 1 - Orange and White Pair 2 - Blue and White

Inner Sheath Sheath Material - PVC (INSU110-APLA043) ID=4.7 mm OD=5.6 mm

Designation

1

Ch2- Ventricle +ve

2

Ch2- Ventricle -ve

3

Ch1- Atrium +ve

4

Ch1- Atrium -ve

3.2.4 Appearance - Product picture

7

Stimulus Extension Cable MP3070 (12m) & MP3126 (24m)

3.3 Labelling 3.3.1 Product Label (Placed on plastic bag):

3.3.2 Labels on the product Located on cable near female connector:

MP3070 A.XX LYYYY Where: XX = revision of cable YYYY = Lot number of cable

8

Stimulus Extension Cable MP3070 (12m) & MP3126 (24m)

4. INSTALLATION

4.1 Cable placement q

Install the MP3070 or MP3126 as shown in Figure below inserted between SGU, MP3008 and the Stimulus Connection Box, MP3014, (or the MP3086)

B AC K U P M AN U A L PAC E C O NTR O L

M ow a iners P B at t e r y P ow er

ATR IUM

EP Recording Equipment

Ventricle Atrium

Stimulus Connection Box,MP3014

Patient Area

Pace- V QRS Sense B at ter y

P A CE O N /O FF

VE NTR IC LE

Backup Manual Pa c e

CH ECK LEAD

WAR N I N G

C u r r e nt ( m A )

Potentially dangero us output. For us e by qualified a crdiologisto n l y .

` P o we r L E Ds

CH ECK LEAD

P ace I nt erv a l( m s)

at t er y LB ow P C P ace C ont r ol

EM R E GE NC Y FI XED PA CE O UT PU T

P A CE O U T PU T

B AC KUP EN A BLE

!

! Plug ni to paceVentricle: 100 bpm @ 5 mA.

EPS 3 2 0 Car d i ca S tim u l aot r

Normal Pace Output Green s o c k e t

Em er g e nc y Pa c in g

Extension Stim Cable MP3070 (12m) OR MP3126 (24m)

Control Room

Figure 2 Connection for Two Channel configuration.

Figure 3 Connection for Four Channel configuration.

q

Cable may be placed under the floor in suitable channels / conduits or in the ceiling.

q

Note that cable connectors are withdrawn by pulling on the connector jacket, the cable can not be disconnected by pulling on the cable itself and will be damaged by doing so.

q

Cable must be supported throughout its course, it should hang unsupported for any length.

q

Ensure that the cable connectors on both sides are in an accessible location for easy accessibility during servicing.

q

Note the warnings below intended to prevent leakage currents explained in Figure 5 and Figure 6.

9

Stimulus Extension Cable MP3070 (12m) & MP3126 (24m)

Warning: To prevent patient electrocution through capacitively coupled leakage currents, install Stimulus Extension cables MP3070 and MP3126 away (>10mm) from mains energised cables and within insulated conduits. These extension cables form part of the Class CF patient isolated circuit. Although this cable is custom manufactured to minimize external cable capacitance, care must be taken to maintain appropriate patient circuit isolation. Warning: In order to prevent electrocution hazards to the patient through conducted or capacitively induced leakage currents, MP3070 and MP3126 cable installation must be (i) appropriately insulated from any nearby mains wiring to prevent injection of mains voltage through broken insulation, (ii) must not be installed next to mains voltage–energised cables, (iii) should not be installed in contact with or within conductive grounded conduits, and (iv) installation lengths should not exceed 24m. Installation must be acceptance tested by biomedical engineer for Patient Applied Part, Class CF device. Laying the stimulus extension cable within grounded conduits – metal or concrete, introduces almost 0.5uA of applied mains earth leakage current per metre, and a length of > 24m may exceed the allowable safe limit of 10uA. Do not install the stimulus extension cable in any conduit carrying mains cables for longer than 2 m or 6 feet, and always ensure adequate insulation and separation from the mains cable.

MP3070 or M P 3126 MP3070 or M P 3126 Mains Cable

Do not install parallel to mains cables

Do not install on or within grounded conduits

MP3070 o r MP 3126

Install within insulated channels with other data / signal cables Figure 4 Installation do’s and don’ts.

EMI - capacitatively coupled leakage current

SGU

Mains Cable Leakage current to ground

A

N

uA

Non-isolated (i.e. ground-referenced) Mains Voltage 240 VAC

Figure 5 Patient hazards from incorrect installation: Applied Part earth leakage current.

10

Stimulus Extension Cable MP3070 (12m) & MP3126 (24m)

Applied Part Capacitance to Ground

Single Fault Inject Mains SGU

Grounded Conduit Applied Part - Single Fault Leakage current to ground

uA 240V AC

Figure 6 Patient hazards from incorrect installation: Applied Part single fault capacitive leakage current to ground.

4.2 Installation Testing: Test Item

Expected result

1.

Using Micropace Test LED verify channels by pacing Atrium and then Ventricle

Green LEDs lights when pacing (red LED cable to +ve to) No LED lights when pacing contralateral channel.

2.

Installation electrical safety acceptance test. The hospital biomedical engineering service or equivalent must verify acceptability of installed system leakage current.

Leakage currents comply with ISO60601-1 or UL2601-1; in particular <10uA for patient auxiliary and applied mains patient leakage current, measured at the catheter terminal box.

Pass / Fail

If this test fails, with a higher leakage current being measured. The SGU device should be installed under the Patient Bed and the stimulus extension cable should not be used. Another cable is then required to connect to the PC, the cable required is the RS232 extension cable MP3084-12 or MP3084-25.

5. USER INSTRUCTION The MP3070 and MP3126 Stimulus Extension Cables are part of an isolated protected patient circuit. Protect cable from damage, such as crushing by trolley wheels, stretching or bending into acute angles. Do not lay mains cables in close proximity to the stimulus cables.

5.1 Maintenance Suggested preventative monthly maintenance: inspect, check the cable for damage and clean with a cloth dampened with standard hospital equipment cleaning agents such as 10% ammonia or 10% bleach, isopropyl alcohol, Cidex, or mild soap. Do not immerse.

11