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Safety Standards Applicable or
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If any Statutory/Legal
Requirement applicable for
this product
Details of Legal Documentation
Spare parts details of the
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 Medical Equipment and Accessories and Supp
Class:- Medical diagnostic imaging and nuclear medici
Sub Catogery- Cardiac pacemakers and related pr
Product Category : Pacemaker (Cardiac pacemaker generators or cardiac resynchr
FIELD
S.NO Parameters FIELD TYPE
Category
APPLICA

1 Application Enumerable Mandatory

TYPE
Type of the Pacemaker according to
1 Enumerable Golden
the number of chambers or leads

Type of the Pacemaker according to

2 Enumerable Golden
the programming

3 Pacing Polarity Enumerable Golden

4 Sensing Polarity Enumerable Golden

Pacemaker operating modes (Pacing Mandatory /

5 Enumerable
modes) Filter

Mandatory /
6 Measurable
Filter
Mandatory /
7 Measurable
Filter
Mandatory /
8 Enumerable
Filter
Mandatory /
9 Measurable
Filter
Mandatory /
10 Measurable
Filter
Mandatory /
11 Measurable
Filter
Mandatory /
12 Measurable
Filter
Mandatory /
13 Measurable
Filter
SAFETY / REGUATOR

1 International radio certification Enumerable Mandatory

2 MRI safe / MRI conditional device Enumerable Golden

3 Conformity to Standard Enumerable Mandatory

4 Regulatory approvals Enumerable Golden

ENVIRONM

Storage Temperature (before

1 Measurable Mandatory
implanting the device) (Deg. C)

GENER

1 Pacemaker housing material Enumerable Golden

2 Housing Ingress Protection Ordinal Golden

Overall Dimension(W x D x H)
3 Text Mandatory
(mmxmmxmm)

4 Weight (G) Measurable Mandatory

5 Volume (CC) Measurable Mandatory

6 URL for datasheet of the product Text Mandatory

BATTE
Mandatory /
1 Battery Type Enumerable
Filter
Mandatory /
2 Battery Voltage (V) Measurable
Filter
Battery longevity (declared by OEM) Mandatory /
3 Measurable
(Years) Filter
SALIENT FE

Mandatory /
1 Salient Features Enumerable
Filter

WARRANTY AN

1 Warranty Measurable Golden

2 Services provided under Warranty Measurable Golden

CERTIFICA
 Type of lab which carried out Test of
Complete Product to prove the Mandatory /
1 Enumerable
conformity of product as per Filter
specification
Test Report No and Date
2 (May indicate 'NA' if not Text Mandatory
applicable)"

Name of the Lab and Address

3 Text Mandatory
(May indicate 'NA' if not applicable)

Should submit the copies of all the

certifications, licenses and test Mandatory /
4 Enumerable
reports to the buyer along with Filter
supplies
*AKBVN :- ALLOW KEY BID VALUE NULL
Equipment and Accessories and Supplies; UNSPS Code: 42000000
iagnostic imaging and nuclear medicine products; UNSPC Code: 42200000
- Cardiac pacemakers and related products; UNSPC Code: 42203500
maker generators or cardiac resynchronization therapy pacemakers CRT-P); UNSPS Code : 42203501
Value 1 Value2 Value 3 Value 4 Value 5 Value 6
APPLICATION

A cardiac pacemaker (or artificial pacemaker), is an implantable and programmable medical device that generates
impulses delivered by electrodes to cause the heart muscle chambers (the upper, or atria and/or the lower, or ven
contract and therefore pump blood to regulate the function of the electrical conduction system of the hear

TYPE

Single chamber pacemaker Dual chamber pacemaker Bi-ventricular pacemaker

fixed-rate on demand rate-responsitive

Both unipolar and bipolar

unipolar Pacing bipolar Pacing
Pacing

Both unipolar and bipolar

unipolar Pacing bipolar Pacing
Pacing

VOO mode; AOO mode; DOO mode; OAO mode; OVO mode; ODO mode; VVI mode;
AAI mode; ADI mode; DDD mode; DVI mode; VDI mode; DDI mode; VDD mode; VAT mode;
VVT mode; AAT mode; AOOR mode; DDDR mode; DDIR mode; DVIR mode; DOOR mode; VVIR mo
VDIR mode; VOOR mode; AAIR mode; ADIR mode; Bi-ventricular pacing mode

SAFETY / REGUATORY COMPLIANCE

Yes
Yes No

complies the requirements of EN 45502-2-1 (latest) or equivalent

US FDA or equivalent approved regulatory authorities; DTAB / CDSCO

ENVIRONMENTAL

GENERIC

Titanium

NA(0), IP65(1), IP66(2), IP67(3),IP68(4)

BATTERY

Lithium-ion

SALIENT FEATURES

Automatic Pacing, Automatic Sensing, Automatic Lead Monitoring, Diagnostics, Patient Data Manageme

WARRANTY AND SERVICES

12, 18, 24, 36, 48, 60

CERTIFICATION
OEM, Govt Lab, NABL accredited Lab, ILAC accredited Lab, NA

Text Limit :-120

Text Limit :-120

Yes
 UOM :- NUMBER
Price :-75000- 5 lakh

e : 42203501
Unit/Remar
Value 7 Value 8
k

dical device that generates electrical

ia and/or the lower, or ventricles) to
nduction system of the heart.

mode; VVI mode;

DD mode; VAT mode;
Multi Select
; DOOR mode; VVIR mode;
lar pacing mode
uivalent

B / CDSCO

AKBVN

AKBVN

AKBVN

AKBVN

Deg. C

Deg. C

s, Patient Data Management, Multi Select

Years
Lab, NA

AKBVN

AKBVN